Resvida (Resveratrol) Clinical Trial & Effects of a Calorie Restrictive Diet

The Washington University School of Medicine is recruiting for a clinical trial studying the effect of Resvida (a natural supplement containing resveratrol) to a calorie restrictive diet. A calorie restrictive diet constitutes about 30% less of the normal dietary guideline per day. The goal is to determine how the antioxidant resveratrol compares to the effects of a restrictive diet on the gene expression profile, lipids, how well insulin is working to control blood sugar and other blood and tissue markers of metabolic and cardiovascular health.

DSM Nutritional Products, LTD markets Resvida. Even though it’s marketed as a dietary supplement, it’s a natural product and does not get FDA approval.

Resvida has been in development for over ten years and is of synthetic form but claims to be ‘nature identical.’

This is a double blind study meaning no one knows if the subject is getting drug or placebo (other than the researchers).

Ages 35 to 70
Females only

Read here for more information on qualifying for this study.

Surprisingly, most of the other recruiting trials are for cancer indications. I am impressed that they are conducting a clinical trial to determine safety and efficacy in order to make a better claim.

 

Mice, human skin cells converted into fat burners

Recent research indicates they might have identified a molecular switch that causes the development of brown adipose tissue.    This might lead to the ability to take obese patient’s cells into the lab and transplant those to create brown adipose tissue that burns off excess  energy.

Here is more on the story:

“When it’s activated — usually by cold — brown adipose tissue initiates a series of pathways that convert free fatty acids and glucose into heat, rather than storing them.   In humans, brown fat is usually found in infants, who are unable to maintain body heat by shivering. The tissue had been thought to vanish long before adulthood, until three studies earlier this year showed it can still be present and active in later life.

Infants generate brown fat to maintain body heat. It was thought that the tissue was not found in adults, but discoveries made earlier this year showed that adults do in fact generate brown fat. If scientists are able to find a way to produce more brown fat in adults, it could lead to better weight control treatments. Researchers say the discovery may lead to treatments that involve removing tissue from a patient, adding the proteins and returning it to the patient to generate brown fat.  Another possibility is developing a drug that can produce the effects of the protein switch.”

 

Rush Limbaugh’s Quick Weight Loss Center Experience: I’m Trying It

My father told me about Rush Limbaugh’s reported 90 pound weight loss since March so I had to find out more about it.    They are only in south Florida but they do have a home program at the cost of $449 for a six week supply of various products to achieve your weight loss goal.  Apparently this is the hot topic at the moment and has drummed up a lot of Google searches for this place.  As I already admitted, I jumped on the chance to learn more.

On the website, they have the program and their products you need as well as sample recipes.  Rush is touting the easiness of this program but does not want to get caught up being a spokesperson.  I performed various checks and what I could glean from the information, you start out on an Atkin’s type diet for two to three days and then cut your caloric intake to 1500 a day which is pretty good.  He watches the meat consumption and doesn’t double his meat intake and keeps it to one serving.  Alcohol is off limit even though he said he most likely could have one to glasses of wine a week but opts not to.  The sample recipes look good and if you are an avid dieter like me, the plan sounds interesting but not sure it does at $449 for the six week period considering you are still buying your food from the grocery store.

The testimonies are good and promising and they do sponsor contests.

Want to track my progress?  Go to my other website for my daily journal as I’ve already lost 12 pounds.

 

*I have not been paid or compensated for my QWLC review

 

Fiber for Good Health

If you are like me, you are paying more attention to getting healthier and finding ways to not only lose or maintain weight but also to retain some youthfulness as long as possible. More and more studies claim that one key to retaining a better youthful appearance is maintaining calorie intake. Another big claim is eating properly and getting the correct amount of nutrients every day. I have read many different sources that tout the benefit of fiber in not only keeping our bodies regulated but also in helping to satisfy an appetite. In an effort to feed this information overload and the quick road to weight loss and better health, many products are on the shelves making many claims.

Fiber is a source categorized as soluble or insoluble.  Soluble is the type found in various products in the grocery store packaged into things such as ice cream and cookies.  Insoluble are found in fruits, vegetables and whole grains.   Both types of fiber are not digested in the body but the ways they are excreted is different.  Soluble forms a gel when mixed with liquids and insoluble is excreted through the intestines intact.  This ability of insoluble to remain largely intact provides the benefit removing bulk.  This removal of toxic material helps to maintain good intestinal health and good control of pH balance.  Soluble fiber binds with fatty acids and provides benefits such as lowering total and LDL cholesterol and  helps those with diabetes since it helps to regulate blood sugar.  Soluble fibers assist in prolonging digestion thus slows down the emptying time in the stomach which regulates the amount of sugar released and absorbed.

So why is fiber so important to our bodies?   It helps to promote good health and helps to ward off some chronic diseases.   Studies have suggested it can help to prevent certain cancers such as colon and breast cancer, it may help to stabilize cholesterol which in turn, may help to reduce heart disease.

The best sources of soluble fiber include:

• Oat and oat bran
• Flax seed
• Nuts
• Barley
• Fruits such as apples
• Vegetables such as peas and carrots

The best sources of insoluble fiber include:

• Vegetables such as dark green leafy varieties
• Fruit and vegetables skins
• Corn bran
• Seeds
• Nuts

The bottom line is what benefit you are looking for in fiber.  If it’s for good bowel health, stick with the insoluble fiber but if you are looking for lowering your cholesterol, use soluble products. 

Possible fiber choices in supplements:

Fiber Choice Fiber Supplement, Sugar-Free Assorted Fruit Chewable Tablets, 90-Count Bottles (Pack of 2)

Citrucel Methylcellulose Fiber Therapy for Regularity, Fiber Caplets, 180-Count Bottle

 

2AP Biochemical Component for Aging and Weight Loss Benefits: Scam?

According to mydailydose.com, a new patented product with 2AP is available.  MyDailyDose’s primary patented ingredient is 2-AEP which is the actual biochemical component making up the outer cell membranes of our bodies.  Their claim is this product will delivers 2-AEP directly to the outer cells thus providing benefits which include strengthening the seal and protecting healthy cells while repairing damaged cells.  They claim it was only available in Germany by a doctor but is now available in America without a prescription.

The complete claim includes:

1. Slows the aging process
2. Increase energy levels
3. Speeds up metabolism
4. Reduces wrinkles and skin spots
5. Restores shine and color of hair
6. Strengthens hair and bones
7. Rebuilds and rejuvenates cells
8. Feel healthier in less than one month

It’s delivered in five doses per day in handy daily packs and has a seven day trial offer.  Watch the small print!

Their clinical trial section on the web boasts of delivering 50,000 daily doses to 300 study participants in one study.  They also note that they have been researching this from 1963 and on.  For more information on their claimed studies and findings, go to http://www.mydailydose.com/v2/prodinfo_scientific.htm

On one website evaluating the claims on anti-aging and a product called Longevity (has AEP in it), I found this:

“This is utter bull,” said Caleb Finch, professor of gerontology at the University of Southern California in Los Angeles. Neither he nor noted expert on aging Leonard Hayflick, a professor of anatomy at the University of California in San Francisco, had ever heard of 2-AEP with respect to research on aging. When asked for medical references pertaining to 2-AEP, Oden said people could find it for themselves. “This is Looney Tunes,” Finch said. “On request you were not given verifiable data for their scientific claims. If they don’t have data, there’s nothing to say.”

Olshansky, Hayflick and Bruce Carnes of the National Opinion Research Center at the University of Chicago gave Longevity the second annual “Silver Fleece” award as “the product with the most ridiculous, outrageous, scientifically unsupported or exaggerated assertions about aging or age-related diseases.” The award, which the three experts created as a lighthearted way to call attention to anti-aging quackery, was announced at a March conference of the National Council on the Aging and the American Society on Aging.

Save  your bucks, as it appears this place, mydailydose, has been reported numerously over potential scams on their product:

1. www.ripoffreport.com
2. www.scam.com
3. www.complaintsboard.com

 

Resveratrol Phase 1 Study, Other Clinical Trials and Biotivia

 

Biomarker studies is the latest focus of the pharmaceutical and biotech worlds.  So much might be learned by looking at how drugs and natural products/ingredients affect the body.   Per Wiki, a biomarker is explained as:  “in medicine, a biomarker can be a substance that is introduced into an organism as a means to examine organ function or other aspects of health. For example, rubidium chloride is used as a radioactive isotope to evaluate perfusion of heart muscle.  

 It can also be a substance whose detection indicates a particular disease state, for example, the presence of an antibody may indicate an infection (see biomarker (medicine) ). More specifically, a biomarker indicates a change in expression or state of a protein that correlates with the risk or progression of a disease, or with the susceptibility of the disease to a given treatment. Once a proposed biomarker has been validated, it can be used to diagnose disease risk, presence of disease in an individual, or to tailor treatments for the disease in an individual (choices of drug treatment or administration regimes). In evaluating potential drug therapies, a biomarker may be used as a surrogate for a natural endpoint such as survival or irreversible morbidity. If a treatment alters the biomarker, which has a direct connection to improved health, the biomarker serves as a surrogate endpoint for evaluating clinical benefit.”

A Phase 1 study published in Cancer Epidemoil Biomarkers Prevention in 2007 studied resveratrol in healthy volunteers.  Phase 1 trials are typically the first trials in which a drug is tested in a human volunteer.  The volunteer can be healthy or have the disease that is being studied.    The hypothesis of this study “was tested that, in healthy humans, p.o. administration of resveratrol is safe and results in measurable plasma levels of resveratrol.”   Resveratrol was provided to a small sample size of 10 healthy volunteers in a 0.5, 1, 2.5, or5 g dose format.

“The results presented here intimate that consumption of high-dose resveratrol might be insufficient to elicit systemic levels commensurate with cancer chemopreventive efficacy.  However, the high systemic levels of resveratrol conjugate metabolites suggest that their cancer chemopreventive properties warrant investigation.”

Here is a website that list some studies of resveratrol .  Unfortunately, it only lists the studies with no results.

There currently eight registered on-going trials:

New York’s Mount Sinai School of Medicine’s Alzheimer’s Disease Research Center is currently recruiting subjects for their study of resveratrol and alzheimer . The University of California is recruiting subjects to perform clinical trials ”to define the actions of resveratrol on the  signaling pathway in a clinical trial in which patients with colon cancer will receive treatment with resveratrol and correlative laboratory studies will examine its effects directly on colon cancer and normal colonic mucosa.  These studies will provide data on the mechanisms of resveratrol action and provide a foundation for future prevention trials, correlative studies and therapeutic clinical research with this agent.” 

For a complete list of the eight trials registered under the government, refer to this link.

Based on researching more about Resveatrol, stay clear of claims of free trials of the product especially if seen on 60 Minutes or Oprah.  I read many consumers who signed up for the “free offer” only to be charged large amounts and no one to contact to get a refund.  I guess it’s marketed under Resveratrol Ultra and under SWM Labs.  Read that small print before buying for all the details such as what others wrote as a scam.  You can buy Biotivia brand for $24 for a 240 mb bottle (250 mg) Biotivia Resveratrol Bioforte 500 Dietary Supplement, Capsules, 60-Count Bottle.

I only noticed headaches when I took resveratrol but can’t say for sure it was attributed to the product. 

 

Bioceuticals?

I guess adding “ceuticals” to a word helps to market a product.  I just posted one on cosmeticeuticals and now I’m reading about bioceuticals and not to mention “bio” being the latest edition of buzz words.  I guess we have a love/hate relationship with the pharmaceutical world as on one hand, we embrace anything with “pharmaceutical” in it but balk and cry foul over high prices or whenver a horrible adverse event occurs in spite of the pre-existing warnings identified and mandated on every script sold. 

What is a bioceutical?  According to Astro Bioceuticals, “remedies derived from natural plants and their derivatives have been used traditionally in various cultures around the world and are still used today to successfully treat many common health concerns. This type of remedy has been termed bioceutical. Such products may range from isolated nutrients, dietary supplements and specific diets to genetically engineered designer foods, herbal products, and processed foods such as cereals, soups and beverages.”

The FDA does not regulate this type of business but they are allowed to market their products to appear as if they are a pharmaceutical product.  Take Biotivia products, for instance, their website on Resteratrol supplements has a host of products with “bio” in the name.  These products range from the infamous Resteratrol to weight loss to immune support.  You can get discounts on bulk purchases and on automatic shipment programs with the option to cancel at anytime.

Their website boasts a lot of information on how they came Biotivia and the process behind their “unique” products:  http://www.biotivia.com/company.html

A story in 2008,  noted a competitor of Biotivia complained about their claims “but most of Biotivia’s print, online and labeling claims were deemed to be “sufficiently supported” by the National Advertising Division of the Council of Better Business Bureaus (NAD).”

The story provided further information of:

“In response to the challenge, Biotivia voluntarily removed disease-related claims which NAD noted was “both appropriate and necessary”.  NAD told the firm it must discontinue claims that its products are processed in a plant that has been GMP-certified by the FDA.  NAD noted there was a reasonable basis for the claim of a 24-month active life but told the company not to suggest this was unique to its product.  The claim that Transmax was being used by universities outside the US was also deemed to be usable, as long as Biotivia disclosed the location of the universities.   It also said Biotivia should more clearly disclose on the label the fact that the resveratrol source is the knotwood plant and not grapes which images of grapes on the label suggest.  Biotivia said it was “more than willing to implement the suggested clarifications noted” in NAD’s final decision.”  NAD ruled in Biotivia’s favor over the rest of the claims.”

Keep in mind that NAD is a New York based voluntary media watchdog group where businesses can pay a fee to provide “scrutiny” on the truth and accuracy of the claims being made.  There is no recourse if a company does not comply with the NADs findings.  However, the NAD does have the authority to refer issues to the FDA and FTC.   The competitor of Biotivia paid $6,000 to have their claims assessed.

The Dietary Supplement Health and Education Act of 1994 does state that the FDA can go after a product when issues are arising.  Although manufacturers are required to inform that FDA on adverse events it’s completely up to the consumer if they report the event to anyone.  I know I never have as I never knew there was a forum to be heard.   Contact 1-800-FDA-1088 or visit http://www.fda.gov/medwatch/how.htm.

According to one doctor in 2008, no clinical trials have been conducted in humans on Resveratrol so the claim of improvement is hardly there (http://scienceline.org/2008/01/23/health-stern-aging/).  The problem with the entire business is, for every doctor that says one thing, you can find another stating otherwise.  It’s why it’s called practicing medicine and I’m all for trying out natural alternatives as long as there is some safety regulations in place.

 

The Flex Mini Skirt® & Slendertone Flex Bottom Toning: Effective?

Okay, this one made me laugh as I have seen the tummy tighteners that have the electrodes that stimulate the muscles to make it simulate sit ups but this is the first time I have seen the The Flex Mini Skirt®  with the claim of “clinically proven to tone the buttocks & backs of thighs.”

Here is the website with the specifics:  http://www.flexmini.com/main/?mcp=3845

Women’s Version of the Belt:

Slendertone Revive Muscle Conditioner

Men’s Version of the Belt:

Slendertone Men’s System Abs Toning Belt

“The Flex Mini Skirt® tones and strengthens the same muscles that are worked when you do squats, lunges, go skiing, running, or work out on the elliptical cross trainer in the gym. All these activities are great for your body’s shape, but hard work. If you thought it was impossible to get a firmer, better shaped bottom and backs of the thighs, think again because the Flex Mini Skirt® makes it easy.

This is not a product that doesn’t results – it is a medical technology that works for everyone. It will work for you too. Just ask any of the over two million Flex product pustomers worldwide…

Clinical studies prove the Flex Mini Skirt® works in as little as four-eight weeks. The Flex Mini Skirt® clinical study showed that:

• 100% of users said it worked
• 92% of users say it is easy to fit into their daily routine
• 90% of users saw an improvement in their body shape
• 90% said they were firmer and more toned
• 90% said the backs of their legs were tighter
• 80% reported that their clothes felt looser
• 80% said their bottom was more uplifted

The best part is you can use it whenever you want to. The Flex Mini Skirt® is clinically proven to deliver a firmer, stronger and more toned butt/hamstring muscles while you are: at home, at work, watching TV, exercising, folding laundry, helping your kids with their homework, taking a walk…virtually anywhere and anytime.”

The cost is $199.99 but it does have  a “60-day money-back guarantee assures customers that they can return their Flex Mini® if needed.  This is one of the added bonuses about ordering the Flex Mini®—the manufacturer is committed to putting their customers above their own interests.  Another feature that emphasizes this point is the 2 year warranty all Flex Minis® are backed with.” 

I can’t find any links to the FDA unless they submitted the application under another name and I can’t find anything relative to actual tests that were ran on efficacy.

This website has alleged user reviews that look overwhelmingly positive (suspicious):  http://naturalsuperfoodsblog.com/exercise-fitness/flex-mini-skirt-user-reviews/

I was able to find that Biomedical Research has an approved application on the FDA site in which they provided an independent research study noting that the 60 women who tried their butt and thigh toning stimulating device did find marked improvement over an eight week period.  However, they do not note if the women in this trial for Slendertone Flex Bottom and Toning device exercised outside of using the belt.  You can buy this at Amazon for only $299.95 (yikes)!  http://www.amazon.com/Slendertone-Bottom-Toning-System-Shorts/dp/B0006JJFSI

Overall, it appears the technology to stimulate the muscles which simulates exercising has been approved by the FDA.  Any readers try it yet?  I actually had the stomach one and used it but I lost my 40 lbs by eating correctly and exercising in conjunction with the belt so can’t really say if it helped or not.   For the cost, I’d say “exercise.”

 

 

Leptin – Hormone for Fat Regulation & Skin Care

Leptin (Greek meaning leptos) is a protein hormone that helps to regulate metabolism, body weight and reproductive function.  I just read a story by Dr. Mercola who I absolutely love since he’s into more organic foods and natural ways to take care of your body.  He’s also anti-vaccination due to the wicked amounts and different types of ingredients that make up this hodge-podge of products injected into humans but that’s another story.  Anyway, leptin as one site explains,  “is expressed predominantly by adipocytes, which fits with the idea that body weight is sensed as the total mass of fat in the body. Smaller amounts of leptin are also secreted by cells in the epithelium of the stomach and in the placenta. Leptin receptors are highly expressed in areas of the hypothalamus known to be important in regulating body weight, as well as in T lymphocytes and vascular endothelial cells.”

Leptin functioning was observed in the 1950’s by studying mutant obese mice.  It was discovered in 1994 by Jeffrey Friedman and collegues via a colony of obese mice.  Per Wiki, this is a biomarker for body fat as well as a way to measure individual energy levels via testing leptin in the serum.  It also states that although the obese mice had little or no leptin, obese people typically have too much leptin.

Leptin plays a big role in many facets of the body but another component is aging.  As Dr. Mercola’s article points out, “Leptin appears to play a significant role in obesity, heart disease, osteoporosis, autoimmune diseases, inflammatory diseases and cancer. These are the so-called ^“chronic diseases of aging^“. 

“To sum up a complex process very simply, the hormones your fat cells produce impact how much you eat and how much fat you burn.

One of these hormones is leptin, and leptin sends signals that reduce hunger, increase fat burning and reduce fat storage. That is, if your cells are communicating properly and can “hear” this message.

If you are eating a diet that is high in sugar and grains — this is the same type of diet that will also increase inflammation in your body — as the sugar gets metabolized in fat cells, fat releases surges in leptin. Over time, if your body is exposed to too much leptin, it will become resistant to the leptin (just as your body can become resistant to insulin).

When you become leptin-resistant, your body can no longer hear the messages telling it to stop eating and burn fat — so it remains hungry and stores more fat.

Leptin-resistance also causes an increase in visceral fat, sending you on a vicious cycle of hunger, fat storage and an increased risk of heart disease, diabetes, metabolic syndrome and more.”

From what I can gather, fish oil might be the source of leptin but it appears that research is on-going.

This product claims to be a skin strenthening complex repair cream:  http://www.loveyourlook.com/NIA24/repair.aspx and its key ingredient has “5% Pro-Niacin allows for conversion of nicotinic acid into NAD, which plays a central role in energy metabolism. NAD helps repair, promotes skin cell generation and stimulates the release of leptin. ”

The Skinstore.com website has 12~ reviews on various skin products from this company which were overall pretty good but it costs $85 for 1.7 ounces.  The ingredients do show olive oil:

Ingredients:

Water (Aqua), Hydrogenated Polyisobutene, Myristyl Nicotinate, Cyclopentasiloxane, Olea Europaea (Olive) Fruit Oil, Cyclomethicone, Squalane, Butylene Glycol, Dimethicone, C12-15 Alkyl Benzoate, Glyceryl Stearate SE, Cetyl Alcohol Glycerin, Polyacrylamide, Pyrus Malus (Apple) Fruit Extract, Aloe Barbadensis Leaf Juice, Glycine Soja (Soybean) Seed Extract, Juglans Regia (Walnut) Seed Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Camellia Sinensis (Green Tea) Leaf Extract, Oenothera Biennis (Evening Primrose) Oil, Triticum Vulgare (Wheat) Germ Oil, Carthamus Tinctorius (Safflower) Seed Oil, Pentadecalactone, Methyldihydrojasmonate, Dodecahydro-3a,6,6,9atetramethylnaphtho( 2,1-b)furan, Myristica Fragrans (Nutmeg) Kernel Extract, Maltol, Ceramide 3,Retinyl Palmitate (Vitamin A Palmitate), Sodium Hyaluronate, Ceramide 2, PEG-8, Phospholipids, Tribehenin, PEG-10 Rapeseed Sterol, Palmitoyl Oligopeptide, Dimethicone Crosspolymer-3,BHT, Laureth-7, C13-14 Isoparaffin, Polysorbate 60, Diazolidinyl Urea, Iodopropynyl Butylcarbamate,Methylparaben,Propylparaben

Amazon.com users (24 in all) gave the Skin Strengthening product 4.5 stars out of 5.0 with one negative user giving a rating in spite of not using it. 

I’m going to try it and will post the results after awhile.  Anyone else try it?

 

GentleWaves® LED Procedure for Fine Lines, Wrinkles, Freckles & Brown Spots

Another facial wrinkle remover I just read about is the GentleWaves® LED.  It was reported in April 2008, the FDA approved this LED system.  Since our skin loses elasticity over time and other culprits such as stress, overexposure to sun, excessive consumption of alcohol, smoking and other pollutants do not help, there are ways to counter that damage.  The variety of products are ranging from creams to serums to botox to laser to LEDs and not to forget, surgery. 

The GentleWaves® LED provides an alleged option to counter these ill effects on our skin.   The GentleWaves® Skin Fitness System claims to help restore and maintain “healthier, smoother and better-looking skin.”   

The only FDA-approved LED device for wrinkle reduction around the eyes is delivered through “Light Emitting Diodes (LEDs) to activate cells causing them to produce collagen and multiply.  By building collagen, wrinkles are reduced and skin retains a more youthful, radiant appearance. LED Photomodulation also simultaneously suppresses collagen-degrading enzymes that assist in the aging process. ”  Some of the claims of this product is it improves the skin’s texture, simulates collagen, shrinks pore size and inhibits those nasty collagenase that are the culprits in attacks against our collagen.

“GentleWaves®, the first LED device FDA-approved for wrinkle reduction, offers a totally natural, non-ablative method for skin rejuvenation. In a process similar to photosynthesis in plants, the LED light interacts with cells and stimulates them to produce more collagen and elastin, while decreasing enzymes that breakdown skin. GentleWaves delivers this light in a unique, pulsing sequence that is administered in just minutes.”

Since GentleWaves® does not utilize on thermal (heat) energy, the claim is there is no potential damage to the skin, the patient will experience no pain or discomfort and there are no documented side effects (yet).   They state that the procedure not only reduces fine lines and wrinkles but can also reduce freckles, brown spots and skin redness.

They do recommend a series of eight to ten treatments which can be done twice per week.

The procedure lasts less than one minute, there is no downtime, painless, no anesthesia, can be used on all skin types and is inexpensive.  Patients report a difference after five to seven treatments.

“LED technology costs about less than half and 35% the cost of comparable laser light therapy,” the inventor says. “It’s a slam dunk for practices who can’t afford these expensive lasers.”

Anyone try it and have any opinion on it?