Dietary supplements are common support therapy and have been shown to improve energy, protein, micronutrients intake, maintain or improve nutritional status. Clinical research enthusiasm fuels a burgeoning development in dietary supplements for management of many chronic disorders, which can unlock incredible market opportunities for dietary supplements through clinical trials.
It is important to understand the clinical trial process for dietary supplements so that you know what to expect when conducting clinical research for your product.
What Is A Clinical Trial?
A clinical trial is carefully designed to closely monitor people’s progress, which can be an essential component for substantiating health claims for foods, food constituents and supplements. When properly conducted, they provide the highest level of scientific evidence into a cause-and-effect relationship. (1)
Many critical factors must be considered in the design of a well-controlled dietary supplement trial to ensure that the objectives of the study will be met and to ensure that the results collected will be relevant to the proposed health claim. Also, Good Clinical Practice (GCP) guidelines should be followed to ensure the credibility of clinical study data and the protection of study subjects.
Under FDA regulations, an Institutional Review Board (IRB) is group that has been formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup.(2) IRBs can also be called Independent Ethics Committees (IECs).
Best practices dictate the use a double-blind placebo controlled (the gold standard) clinical trial encompassing a wide diversity of population and age groups. These studies are expensive and time consuming, but offer the most reliable and verifiable data for the efficacy of a substance with regard to other testing methods.
Supplements Generally Considered Safe Through Historic Use
According to the Food and Drug Administration (FDA) Dietary Supplement Health and Education Act (DSHEA) of 1994 (3), all supplements include vitamins, minerals, amino acids, herbs, and other botanicals are considered safe until they are proven unsafe. Furthermore, anything prior to 1994 was not regulated. Thus, any and all supplements generally found on the shelves of your local supermarket or pharmacy is generally considered safe. In general, the FDA recommends avoiding:
· Products that claim to work like prescription drugs—anything that claims to treat an illness or cure a medical condition.
· Products that are advertised through mass e-mails.
· Products marketed mainly in a foreign language.
· Products that promise weight loss, body-building, or enhanced sexual performance.
· Products that say they are a legal alternative to anabolic steroids
as they have been known to be tainted with potentially dangerous additives. (4)
A dietary supplement is considered “new” if it contains an ingredient not recognized as a food substance, unless it was sold as a supplement before October 1994. If it is new, the manufacturer must provide the FDA with reasonable evidence that the new ingredient is safe before the supplement is marketed to the public. (4)
Advantages of Clinical Trials for Dietary Supplements
All prescription and non-prescription drugs are regulated in the United States by the FDA. But dietary supplements are treated more like special foods. In 1994, the DSHEA defined dietary supplements as a category of food, which put them under different regulations than drugs. They are considered safe until proven otherwise. The DSHEA says that dietary supplements cannot contain anything that may have “a significant or unreasonable risk of illness or injury” when the supplement is used as directed on the label, or with normal use if there are no directions on the label.
Due to these guidelines, it is very advantageous for any company bringing a new (or old, but repurposed) dietary supplement ingredient to market to perform some form of study to prove the substance is not unsafe. The most complete way to do this is by w...
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