Embracing a Healthy Family: Resveratrol, Biomarkers and Clinical Trials

Resveratrol, Biomarkers and Clinical Trials

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: http://www.anyvitamins.com/resveratrol-references.htm . 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 http://www.delay-ad.org/trials/resveratrol . The University of California is recruiting subjects to perform clinical trials ”to define the actions of resveratrol on the Wnt 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.” http://clinicaltrials.gov/ct2/show/NCT00256334?term=resveratrol&rank=2
For a complete list of the eight trials registered under the government, refer to this link: http://clinicaltrials.gov/ct2/results?term=resveratrol .

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). I only noticed headaches when I took resveratrol but can’t say for sure it was attributed to the product. Biomarker study 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: http://www.anyvitamins.com/resveratrol-references.htm . 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 http://www.delay-ad.org/trials/resveratrol . The University of California is recruiting subjects to perform clinical trials ”to define the actions of resveratrol on the Wnt 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.” http://clinicaltrials.gov/ct2/show/NCT00256334?term=resveratrol&rank=2
For a complete list of the eight trials registered under the government, refer to this link: http://clinicaltrials.gov/ct2/results?term=resveratrol .

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

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