WASHINGTON, Dec 11 (Reuters) - More patients with serious diseases could get experimental drugs under revised rules proposed on Monday by the U.S. Food and Drug Administration that also detail how manufacturers can charge for them.

The FDA said the changes spell out more clearly which patients are eligible for special access to the unapproved products, as well as the fees they may have to pay.

“When people are dying of a disease and they’ve run out of therapies, not everyone wants to take an investigational drug under those circumstances.

But some people definitely want to take that risk and we want to give them that choice,” Dr. Janet Woodcock, FDA’s deputy commissioner for operations, told reporters.

Experimental, unapproved medicines have been available to some patients under certain circumstances since the 1970s, the agency said. In the past, thousands of patients with HIV and AIDS, cancer and heart problems have been able to use some drugs prior to approval.

But Woodcock said the current confusion about the regulations made them “one of the best kept secrets around” for needy patients. She could not estimate how many more people might now seek experimental drugs but said the new details should help.

Patient groups have long been pushing for the FDA to expand access for desperate patients.

In 2003, two advocacy groups sued the FDA seeking patient access to new cancer drugs that were shown to be safe in initial tests but had not yet received approval. The case was sent back to lower courts for review in May.

The new rules, which are open for 90 days of public comment, detail access for small groups of patients as well as individuals with serious but not immediately life-threatening conditions, the FDA said. It also clarifies how companies should calculate their fees.

Under the proposal, companies could charge consumers for what it cost in materials and labor to make the medicine as well as shipping, handling and other administrative expenses, the FDA said. Patients participating in clinical trials also could have to pay.

Woodcock said the rules aimed to help academic researchers and small companies offer experimental drugs when they otherwise could not by allowing them to recoup their costs. Larger drugmakers usually do not charge patients and the FDA expects that to continue, she said.

Current, vague rules kept many manufacturers from helping such needy patients, she said, adding the revisions have “nothing to do with profits” and will be strictly monitored.

She also cautioned against company attempts to commercialize their products with such early use, adding they are expected to participate while continuing to develop them for future regulatory approval.

Woodcock would not comment on how the new rules could impact the pending lawsuit. Representatives for the Abigail Alliance, one of the groups that filed the suit, could not be immediately reached for comment.

Every year at this time, cancer doctors and researchers gather at the annual Breast Cancer Symposium in San Antonio, Texas, to hear the latest news in the field.

This year we heard surprising news from investigators at M.D. Anderson: there was an overall 7 percent relative decline in diagnosed cases of breast cancer between 2002 and 2003. The number of breast cancer cases had increased in the 20 years before 2002.

The steepest decline - 12 percent - occurred in women between ages 50 and 69 diagnosed with estrogen receptor positive (ER-positive) breast cancer. ER-positive breast cancer depends on hormones for tumor growth. One reason for the decline, according to the researchers, may be the 2002 announcement that hormone replacement therapy (HRT) is a major contributor to breast cancer growth. The announcement led thousands of women to stop taking these drugs.

Although the researchers aren’t 100 percent sure that stopping HRT is the only reason for the decline, Peter Ravin, Ph.D., the study’s senior investigator, says “it makes perfect sense” if you consider that use of HRT may be an important contributing factor to breast cancer development. “Research has shown that ER-positive tumors will stop growing if they are deprived of the hormones, so it is possible that a significant decrease in breast cancer can be seen if so many women stopped using HRT,” he says.

This news isn’t to be confused with the actual number of breast cancers diagnosed each year, though. Unfortunately, that number has continued to climb. The number of women in the target age group above swelled dramatically as baby boomers came into midlife.

As the denominator swelled, so did the numerator, the number of breast cancers diagnosed. This number includes new cases as well as recurrences of breast cancer in women previously diagnosed. The big news comes from the fact that researchers expected a larger numerator and instead saw a reduction.

So is not taking HRT the answer? I don’t know. There are several other issues that came to my mind when I read this breaking news. Here are a few:

• Is the 2002 announcement that HRT contributes to breast cancer the most important reason for the decline in new breast cancer cases? Or are more women not taking HRT because fewer hysterectomies (removal of the uterus) and more hysteroscopies - a procedure that examines and removes masses from the uterus without the need for a hysterectomy - are taking place, avoiding the need for HRT?

• Because HRT increases breast density, which makes it harder to image breast tumors, discontinuing it should improve detection of breast cancers that previously were hidden in the image. How does that get factored in?

• Breast cancer takes several years to grow, so stopping HRT for a year or less won’t necessarily prevent someone from getting it; the tumor will be smaller when detected because it’s been fed for a shorter time.

• What about high-risk women who are taking tamoxifen or raloxifene to prevent breast cancer? What do those statistics look like? Are there more women doing this and what impact might it have on breast cancer rates?

• How many women in the 50 to 69 age group had screening mammograms in 2003? Is that up, down or the same as 2002?

All of these factors may also have influenced the reduction. So, although the news certainly is exciting, I want to learn more before I hang my hat (or my bra) on the HRT reduction hypothesis.

The Food and Drug Administration plans to improve the Web portal so that anyone can report adverse drug effects and will try data mining to learn more about any problems with regulated medicines.

The agency, which has been criticized for paying too little attention to prescription drugs after they are approved for sale, also will offer a downloadable software module that doctors and other practitioners can use to report on drugs. The module will work with existing electronic medical records, making reporting easier for those with EMR systems.

Dr. Scott Gottlieb, the FDA’s deputy commissioner for medical and scientific affairs, disclosed those and other information technology tactics in a November speech. Gottlieb did not give a timetable for completing the projects, and FDA spokeswoman Crystal Rice said such questions were premature.

The agency plans to proceed with a single portal for reporting all problems with FDA-regulated products, she said, but the scope of the project is still under discussion.

Today’s MedWatch portal “is a valuable tool, but we know that it is not being used as effectively as it ought to be,” Gottlieb said in his speech. The agency gets only about 10 percent of the adverse-event reports that it would find helpful, he said, and few of the reports come from doctors and patients.

“We think we can improve reporting by taking steps to make our Web portal more automated and easier to use,” he said. Besides improving usability, the agency will try to collect more information through MedWatch, Gottlieb added.

The FDA also will begin producing a regular, perhaps weekly, report to the public so that everyone can find out what kinds of problems are being reported, he said. The report may prompt more health professionals to contribute data on drugs’ effects, he added.

Gottlieb said the FDA also is concerned about delays in reporting adverse effects and will try to get more timely information. “With the advent of electronic medical records, there is a lot of opportunity to develop more active reporting systems that can scan medical information –- real-time or near real-time –- and look for the tell-tale signs of a potential drug safety problem much earlier than the passive reporting systems that we rely on today,” he said.

The agency is collaborating with the Massachusetts Institute of Technology on a data-mining project that builds on biosurveillance techniques, Gottlieb said. “Such systems could scour federal and private health care databases in real time for unusual and emerging patterns that could indicate potential safety concerns,” he said.

Minerals - Why do we need them?

Minerals are essential constituents of all cells. They form the greater portion of the bones, teeth and nails and are also essential components of the soft tissues, muscles, nerve cells, enzymes, glandular secretions (i.e. ¡V hormones) and blood. They regulate the “excitability” of muscle and nerve tissues, and are essential in maintaining proper osmotic pressure equilibria. Minerals are also necessary to maintain a proper acid-base balance, and play an important role in regulating blood volume and maintaining the delicate water balance in our body tissues. Although minerals comprise only 4-5 percent of our body weight, without them life itself would be impossible.

Modern man has become increasingly reliant on canned, frozen, pre-cooked, chemically altered and denatured “food”. Many farming methods such as “mono-cropping” (growing one crop on the same land year after year), the extensive use of fertilizers high in nitrogen, phosphorous, and potassium but deficient in many other key minerals and trace minerals, and the harvesting of fruit and vegetables before they have fully ripened, have made it nearly impossible for even health conscious individuals to obtain all the nutrients they require for optimum health from the foods they consume.

In view of these factors the need to supplement a “balanced” diet with additional vitamins and minerals seem apparent. The form these supplements should take is of prime importance when considering how best to attain maximum “bioavailability”.

Mineral Absorption - The Digestive Process

The prime function of our digestive system is to break down our foods into the various nutrient components necessary to maintain health. This process begins in the mouth where salivary amylase initiates the breakdown of starches. It continues in the harsh environment of the stomach where hydrochloric acid and gastric enzymes begin breaking down proteins (and to a very limited degree, carbohydrates). After a period of one to four hours (depending on the combination of foods ingested) peristaltic action pushes the “chyme” out of the stomach and into the small intestine where bile and various pancreatic enzymes complete the digestive process. It is here in the upper portion of the small intestine where all minerals are ultimately absorbed.

Minerals are released from our food by the action of hydrochloric acid and gastric enzymes in the stomach. Once free, the mineral, which carries a positive electrical charge, will either:

1. Attach itself to a very strong negatively charged carrier, thereby creating a bond too strong to be broken in the stomach, or

2. Pass into the intestine as an unattached, positively charged mineral ion.

Should the former occur, the ionic compound, owing to the strength of the bond holding its mineral and mineral carrier components together, will pass through the intestine without being further digested. In other words, a mineral in this form is of little value to the body.

On the other hand, a free positively charged mineral can only be assimilated (in the small intestine) if its charge is reduced to zero. This is because the intestinal villi (short filament-like projections which line the intestinal wall and through which absorption of most vitamins and all minerals takes place) carry a negative charge and thus create an attraction between themselves and the positively charged mineral ion (called a “cation”). This attraction is so strong that the metal cations will adhere to the villi without being absorbed into the bloodstream. The free mineral¡¦s positive charge can be neutralized by surrounding it with a binding protein at the villi. This is a slow process, and as the intestine can only assimilate a small amount in a given period of time, much of the mineral will pass its receptor site before this neutralization can be achieved. Consequently, much of the ingested mineral is never absorbed.

Gluconates, Citrates, Sulphates, etc.

Mineral salts such as calcium gluconate, zinc citrate or ferrous fumerate can be likened to two magnets of opposite charge; the mineral portion (calcium, zinc, iron, etc.) carries a positive charge, and the mineral carrier, the negative charge. The mineral and mineral carrier are held together by the attraction of their opposite charges, an attraction which yields a net charge of zero. If this electrochemical attraction was strong enough to hold the compound together in the acid environment of the stomach, a significant amount might pass into the small intestine to be absorbed through the villi.

However such is not usually the case. Because the charges held by the mineral and mineral carrier are relatively weak, so too will be the attraction between them. Consequently, this bond is easily broken by the stomach¡¦s digestive enzymes, and the positively charged mineral, now liberated from its carrier, will follow the usual digestive processes described earlier. It is apparent that these types of mineral compounds (citrates, gluconates, sulphates, etc.) permit only a very limited amount of the mineral to be absorbed. In fact, in a study measuring the retention of iron in body tissues after high oral administration of either ferric gluconate, ferric citrate (these are sometimes, though erroneously, referred to as “chelates”) or inorganic ferrous sulphate, the percentage of the original oral dose of iron actually retained in the tissues was only 6% for the citrates, gluconates, and sulphates.

In other words, the so called mineral “chelates” were no better absorbed than the inorganic mineral salt form. (Various experiments have shown that only 1-6% of minerals in these forms is ultimately absorbed into the bloodstream). In light of these factors there is an obvious need for minerals supplement that is more readily absorbed than either the “organic” or “inorganic” mineral salt forms. A supplement in which minerals are chelated with amino acids seems to provide the best answer.

The Amino Acid Chelates

The ideal chelating agent is one which:

1. Provides a bond strong enough to hold the mineral chelate together while it is in the stomach, yet not so strong as to make its central mineral ion unavailable for absorption, and

2. Allows the creation of a mineral chelate which carries a zero electrical charge so that the mineral ion encased therein might be attracted to the villi to a degree sufficient to permit assimilation into the bloodstream.

It has been established that amino acids (the “building blocks” of protein without which the formation of any living tissue is impossible), especially those producing neutral chelates, fulfill all essential characteristics required as chelating agents. Since the mineral is embedded in a cyclic or ring-like molecular configuration comprised of amino acids which bear no electrochemical charges, and the intestinal villi have receptors with the affinity to absorb 95% of all amino acids*. Properly absorbed amino acid chelated minerals will be absorbed through the villi intact (* some minerals may enter the bloodstream through the receptor sites of the amino acids simply by being “hidden” within the amino acid). This form of chelate cannot cause the intestinal problems sometimes encountered with prolonged use of mineral gluconates, citrates, sulphates or carbonates.

Enzyme Hydrolysis of Protein - A Better Way!

The recently developed enzyme hydrolysis method of chelating amino acids with minerals has several advantages over processes using strong acids of bases:

1. Enzyme hydrolysis of protein breaks down the protein molecule more thoroughly into its component peptides and polypeptides, thus providing chains of these units better suited to form strong, effective chelates.

2. The enzyme hydrolysis process is almost a duplication of that which occurs naturally in the gastro-intestinal tract. The high temperatures required under extreme acid or base conditions maintained for long periods of time (about 24 hours) are not employed in the enzyme method of hydrolyzing protein. This avoids the formation of harmful oxidation products.

3. Because the enzyme hydrolysis process takes place under neutral or near neutral pH conditions, it will not destroy acid and temperature sensitive amino acids such as tryptophan and methionine (as will methods using the acid hydrolysis procedure). Hydrolysis of protein using a strong basic medium also results in the destruction of serine, threonine, and other amino acids not affected by the comparatively low (not more than 50-60„a C.) temperatures used in the enzyme hydrolysis method.

4. When preparing chelates using highly acid or basic pH solutions for hydrolyzing the protein, it is essential that a neutralizing salt solution be used. This will result in the formation of significant amounts of salts (rather than chelates). Because a neutral or slightly basic medium is used in the enzyme hydrolysis technique, there is no need for this neutralization step.

The Importance of Synergistically Balanced Minerals

Often the absorption or “bioavailability” of a particular mineral can be enhanced by the simultaneous ingestion of certain minerals, with balanced vitamins, or enzymes. These “synergistic factors” may aid in the actual absorption of the mineral. Additionally, extra quantities of a particular mineral may be required if another mineral displaces or “uses up” the first in order to be absorbed itself. For example, an increased intake of calcium will bring about a decreased concentration of magnesium (as shown by an increase in urinary excretion). Some examples of this “synergism” between minerals and their “associate” nutrients are:

IRON - Its absorption is enhanced by combining it with copper, vitamin C and various B complex members.

MAGNESIUM - Vitamin B-6, calcium and phosphorous all work to effect its assimilation.

ZINC - Vitamin A and copper increase its absorption. Further, the addition of copper prevents its (copper¡¦s) depletion from body stores.

CALCIUM - Its bioavailability is greatly enhanced by the presence of vitamin D and magnesium (Although phosphorous is also vital for calcium absorption, adequate supplies are usually obtained from a number of commonly consumed foods [flesh foods, nuts, seeds, grains, etc.]).

MAGNESIUM - The “synergistic factors” that facilitate its assimilation are vitamin B-1, and vitamin C.

SELENIUM - Vitamin E and C enhance its effectiveness and (like selenium) are also important anti-oxidants themselves.

Summary

Certain conditions are necessary before optimal mineral absorption can be attained.

1. The chelating agent must provide a bond of stability sufficient to hold the mineral chelate together in the stomach, yet allow its breakdown in the small intestine where mineral absorption takes place.

2. Whether they are formed by the natural digestive process or in the laboratory, all mineral chelates must be in a water soluble form.

3. The chelating agent must permit the creation of a mineral chelate that carries a neutral charge. This will create an attraction between the chelated mineral and negatively charged villi strong enough to permit optimum absorption into the bloodstream, yet sufficiently weak to eliminate the possibility of the mineral adhering to the villi (and thereby not be absorbed).

4. The completeness and thus the effectiveness of protein as a chelating agent is best preserved by the use of the enzyme method of protein hydrolysis. This method does not require the harsh acid or base mediums and extreme temperatures used in other methods of hydrolysis. Consequently, its implementation preserves the numerous pH and temperature sensitive amino acids which processes the acid and base mediums often destroy.

5. The assimilation, retention and utilization of a mineral is greatly enhanced by its simultaneous ingestion with associate or “synergistic” vitamins, minerals and enzymes.

These nutrients either:

a. Work directly with the mineral to increase its effectiveness,

b. Increase the absorption of the mineral itself,

c. Prevent their being depleted from body tissues, bones, body fluids, etc. due to displacement by their “associate” mineral (i.e. ¡V the excretion of magnesium when calcium is consumed).

Additionally, since all minerals absorbed are simultaneously absorbed through the same receptor site, the latter will not be so “tied up” by one mineral that the others cannot be absorbed. An optimum level of health can only be achieved if, in addition to eating whole, natural food, obtaining sufficient sleep, and exercising regularly, one also selects food supplements of the highest possible quality. Enzyme Amino Acid technology has made possible the creation of minerals that are better assimilated, retained and utilized than ever before. When purchasing vitamin/mineral supplements, choose those formulae such as the SONA, where the minerals are properly chelated and synergistically balanced.

References

1. Frost, A.E. The Science Counselor, Durquesen University Press, Pittsburgh, Pennsylvania. (June, 1956)

2. Schwarzenbach, G., and Freitag, E., Helv Chemacta, 34, p. 1492, (1951).

3. Martell and Calvin, Chemistry of the Metal Chelate Compound, Prentiss Hill Inc., New York, (1952).

4. Robinson, J.W., et al, J. Surg, Res., 5, p.150 (1965).

5. Miller, J.J., Paper Presented to the International College of Applied Nutrition, Pasadena, California, (1962).

6. Franklin, M., et al. J. Amer. Med. Assoc., 166, p. 1685, (1958).

7. Pollack, S., et al, Blood, 24, p.577, (1964).

8. Bates, G.W., et al, Amer. J. Nut., 25, p.983, (1972).

9. O¡¦Dell, B.L., Cornell Nutritional Conference, p. 77, (1962).

10. Greenberger, A.S., et al, Science, 153, p. 315, (1966).

11. Everett, M., Medical Biochemistry, P.B. Hoeber Inc., New York, p. 400, (1946).

12. Fouad, M.T., “Chelation and Chelated Minerals”, J. Applied Nutrition, 28 (1), Spring, (1976).

For cancer survivors, exercising and maintaining a healthy weight are important factors in preventing malignancy’s return, at least for some forms of the disease.

That’s the conclusion of an American Cancer Society report that updates nutrition and physical activity recommendations for cancer survivors during and after treatment.

Among the points contained in the report:

For some kinds of cancer, just 1 to 3 hours a week of exercise can lower the risk of cancer recurrence and death, as well as death from all causes. Exercise has also been shown to improve fitness, fatigue, and several other quality of life aspects in cancer survivors. While a vegetarian diet can help health in some ways, there’s no direct evidence that this kind of diet can prevent cancer recurrence. Survivors who eat a vegetarian diet should ensure that they’re getting an adequate intake of nutrients. A standard multivitamin and mineral supplement in amounts equivalent to 100 percent of the Daily Value can help cancer survivors meet their nutrient needs when it’s difficult for them to eat a healthy diet. However, some supplements — such as those with high levels of folic acid or antioxidants — may be harmful during cancer treatment. Food safety is especially important for cancer survivors, particularly during treatment that involves immunosuppression. Alcohol can affect the risk for new primary cancers in certain areas of the body.

The report is published in the November/December issue of CA: A Cancer Journal for Clinicians.

Currently, nearly two out of three cancer patients in the United States live more than five years after their diagnosis. There are more than 10 million Americans who have been diagnosed with cancer at some point in their lives.

More information:

The U.S. National Cancer Institute has more about life after cancer treatment.

Staying slim and fit is especially important for cancer survivors, because obesity raises the risk of cancer coming back, the American Cancer Society said in new guidelines issued on Wednesday.

“The evidence really is quite strong for the need for cancer survivors to achieve and maintain a healthful weight,” Wendy Demark-Wahnefried of Duke University Medical Center, one of the report’s authors, said in an interview.

The recommendations, updating advice issued in 2001 and 2003, were published in the society’s “CA: A Cancer Journal for Clinicians.”

The report said obesity is a well-established risk factor for some of the most common forms of cancer, including breast cancer in post-menopausal women and cancers of the colon, esophagus, liver, gallbladder, pancreas, kidney, uterus and prostate.

It also cited increasing evidence that being overweight raises the risk for recurrence and reduces likelihood of survival for many cancers.

Demark-Wahnefried said cancer survivors also face a greater risk of heart disease and diabetes, adding, “Obesity is a big risk factor for those diseases as well as second cancers.”

The American Cancer Society said nearly two-thirds of U.S. cancer patients live more than five years after diagnosis, and more than 10 million Americans now alive have been diagnosed with cancer at some time in their lives.

The report said vegetarian diets can have many benefits because they tend to be low in saturated fat and high in fiber and vitamins.

“However, no direct evidence has determined whether consuming a vegetarian diet has any additional benefit for the prevention of cancer recurrence over an omnivorous diet high in vegetables, fruits, and whole grains, and low in red meats,” the report stated.

The report noted that preliminary evidence indicates that for some types of cancer, one to three hours per week of exercise can cut the risk of cancer recurrence and death.

A new study provides the first-ever scientific proof that if you eat slowly, you will eat less — and you will enjoy the meal more.

Women consumed about 70 fewer calories when they were told to take their time eating a meal of pasta and sauce, compared to when they were instructed to eat it as quickly as possible. They also rated the meal as more pleasant when they ate slowly.

“They got more pleasure for (fewer) calories, and more satiety for (fewer) calories,” Dr. Kathleen Melanson of the University of Rhode Island in Kingston told Reuters Health.

Melanson decided to conduct the study when she learned there was no research to support the familiar claim that eating slowly reduces appetite.

She and her colleagues had 30 young women eat a meal of ditalini with tomato and vegetable sauce, topped with Parmesan cheese, under two different conditions. Before each meal, the women had eaten a standard 400-calorie breakfast, and then fasted for four hours.

At one visit to the lab, study participants were given a large spoon and told not to pause between bites and to eat as quickly as possible. At the other, participants ate with a small spoon, which they put down after each bite, and were told to take small bites and chew each bite 15 to 20 times.

When eating quickly, the women took in an average of 646 calories in nine minutes. But when they slowed down, they consumed 579 calories in 29 minutes, according to their report, presented at the annual meeting of the North American Association for the Study of Obesity.

The women felt fuller and more satisfied immediately after they ate the meal and an hour later when they had consumed it slowly, Melanson and her colleagues found.

Eating slowly may indeed promote weight loss, or help people maintain a healthy weight, Melanson noted, given that someone who ate three leisurely meals might consume 210 fewer calories a day than someone who wolfed those meals down.

People who flavor their diets with plenty of onions and garlic might have lower odds of several types of cancer, a new study suggests.

In an analysis of eight studies from Italy and Switzerland, researchers found that older adults with the highest onion and garlic intakes had the lowest risks of a number of cancers — including colon, ovarian and throat cancers.

The findings, which appear in the American Journal of Clinical Nutrition, are in line with some past research. But those studies were mainly conducted in China, and it is unclear if the results are different in Western countries.

Dietary habits are substantially different in China, with garlic intake, in particular, being far higher, Dr. Carlotta Galeone, the lead author of the new study, told Reuters Health.

These latest findings suggest the anti-cancer benefit of these vegetables extend to Western populations, according to Galeone, a researcher at the Mario Negri Institute of Pharmacologic Research in Milan, Italy.

It’s still not certain that onions and garlic have a direct effect on cancer risk. It’s possible, for instance, that onion and garlic lovers also have an overall diet that protects against cancer, according to Galeone and her colleagues.

On the other hand, they note, animal studies and lab experiments with cancer cells have found that certain compounds in onions and garlic may inhibit the growth of tumors. Sulfur compounds found in garlic and antioxidant flavonoids in onions are among the potentially protective substances.

The current findings are based on results from eight studies conducted in Italy and Switzerland. Each study compared healthy older adults to patients with a particular form of cancer, asking participants for detailed information on their diets, physical activity and other lifestyle habits.

When it came to colon cancer, Galeone’s team found that men and women who ate seven or more servings of onions per week had less than half the risk of those who shunned the vegetable. Similarly, garlic lovers were a quarter less likely to develop the disease than people who maintained garlic-free diets.

The vegetables were also linked to lower risks of cancers of the mouth, throat, kidneys and ovaries.

Given what’s known about the biological activity of some onion and garlic compounds, it wouldn’t be a bad idea to spice up your diet with the vegetables, according to Galeone.

It’s probably wise to mix them with plenty of other vegetables, however.

Some research has found that garlic and tomatoes may have “synergistic” cancer-fighting effects, Galeone and her colleagues note. And, in general, experts recommend that people eat a variety of fruits and vegetables every day for overall health.

SOURCE: American Journal of Clinical Nutrition, November 2006.

You’re the body weight you are because of the types of food you’ve eaten as well as the quantity of food. That has to change. The well-worn definition of insanity applies: Insanity is doing the same thing over and over and expecting different results. It’s time to wise up about food choices!

You have to change the types of food you’re eating, both for weight loss and for improved health.

Whole books have been written about what to eat, but let’s give you some fundamentals.

Increase Fresh Vegetables and Fruits

These should be the staples of your diet. In general, the darker the color of the fruit and the vegetable, the better the content of vitamins, minerals, and phytonutrients.

Choose Lean Sources of Protein

Look for poultry without the skin, lean cuts of beef and pork with all fat trimmed away, cold-water fish, and dairy products made with skim milk. Beans, legumes, and some nuts are great vegetarian sources of protein.

Reduce Intake of Fried Food

When food is deep-fat fried, the process essentially implodes fat into the food. Mushrooms and potatoes are great foods, but being breaded and deep-fat fried turns them into fat bombs.

Reduce Intake of Refined Carbohydrates

Bread, pasta, rolls, tortillas, cakes, cookies, and many others should be replaced with whole-grain selections when you need these types of carbohydrates.

Choose Better Fats and Oils

Replace saturated fats from vegetable and tropical oils with olive oil, high-oleic safflower oil, and canola oil. All are low in saturated fats and high in mono- and polyunsaturated fats.

Those are some fundamentals that need to be incorporated into your healthier lifestyle. the best types of foods to eat for a healthier lifestyle in the primary food categories: Protein, Carbohydrates, Dairy, Vegetables, Fruits, and Fats and Oils. Whether you use your own plan, a diet plan or read labels to decide what foods will fit your new lifestyle, making better food choices is critical to lifestyle training.

Researchers studying a group of vegetarians who’d maintained a diet relatively low in protein and calories found that they had lower blood levels of several hormones and other substances that have been tied to certain cancers.

A comparison group of distance runners also had lower levels of most of these substances compared with sedentary adults who followed a typical American diet — that is, relatively high in protein from meat and dairy.

However, the low-protein group also had a potential advantage over the runners: lower levels of insulin-like growth factor 1 (IGF-1), a body protein that helps cells grow and multiply. High IGF-1 levels in the blood have been linked to breast, prostate and colon cancers.

It’s not clear that this all translates into lower odds of developing cancer, but the findings are a “first step” in showing how lower-protein diets might alter cancer risk, according to the researchers.

“I believe our findings suggest that protein intake may be very important in regulating cancer risk,” lead study author Dr. Luigi Fontana, an assistant professor of medicine at Washington University in St. Louis, said in a statement.

He and his colleagues report their findings in the American Journal of Clinical Nutrition.

The findings are based on a small sample of middle-aged adults, including 21 who’d been vegetarians for at least two years; they were recruited through a local vegetarian society and a magazine on “raw” foods.

They were compared with 21 long-time endurance runners the same age, and 21 sedentary adults who ate a typical American diet.

On average, the vegetarians ate just below the recommended daily amount of protein — 0.8 grams per kilogram of body weight. Both the runners and the sedentary group ate significantly more than the recommended amount.

Fontana’s team found that, compared with their sedentary counterparts, the runners and vegetarians had lower levels of several hormones and inflammatory proteins linked to cancer risk.

When it came to IGF-1, specifically, the low-protein group had lower levels than runners did, even though they were equally lean — suggesting an effect of diet and not just body weight, according to the researchers.

In addition, IGF-1 levels in the sedentary group generally rose in tandem with their protein intake.

“Many people are eating too many animal products,” Fontana said, as well as too many processed foods and sugars.

He advised that people try to eat more fruits and vegetables, fiber-rich whole grains, beans and fish, and less red meat. Doing so could bring the amount of calories and protein the average American eats closer to recommended levels — and possibly lower IGF-I levels, according to Fontana.

“We hope to further clarify what happens to cancer risk when we are chronically eating more protein than we need,” he said.

SOURCE: American Journal of Clinical Nutrition, December 2006.