A Study Of Nutraceutical Drinks For Cholesterol (Evaluating Effectiveness and Tolerability)

Completed · Not applicable · Has a placebo group

Conditions studied: Hyperlipidemia

In brief

Great controversy exists about the feasibility and safety of a product that can be employed for self-directed cholesterol reduction. The position that self-directed cholesterol lowering could lead those that do not need lower cholesterol to take the product is likely unfounded. This is because there is no convincing evidence to suggest that there are cholesterol levels so low that a lower one would not be beneficial or conversely be dangerous. Ample evidence exists that cholesterol causes cardiovascular disease and that lower cholesterol places individuals and populations at lower risk. Because of the high cost, insurance concerns and suboptimal access to physician care, a self-directed, effective and safe approach to cholesterol maintenance or reduction would be very desirable. Drug therapy also has been associated with suboptimal results. Though a new concept that addresses cholesterol by several mechanisms simultaneously has been shown to be more consistently effective and with better tolerability, there is still a need for a self-directed cholesterol optimizing alternative. It is, therefore, our intent in this study to evaluate certain foods, specifically nutraceutical containing fruit flavored drinks in the hopes that they can be proven a safe and effective alternative approach for cholesterol management.

Key facts

Study ID

NCT01152073

Run by

Healthy Drink Discoveries, Inc.

People needed

79

Starts

2009-10-01

Expected to finish

2010-09-01

Last updated by the study team

2012-03-16

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All subjects will need to be on their usual diet and
• Not have been on any cholesterol lowering medications for at least two months or eight weeks prior to randomization. The subjects will also need to be off of all dietary supplements or vitamins containing any of the constituents in any of the formulations for the same time period.
• Any baseline cholesterol measurement will be acceptable since there is no convincing evidence of low cholesterol below which a clinical benefit is thought not to occur, nor cellular function compromised,.
• Males 20 to 80 years of age will be acceptable.
• Post menopausal females 55 to 80 years of age.

You may not qualify if…

• Prior myocardial infarction clinically or by EKG criteria including left bundle branch block.
• History of angina.
• History of abnormal stress test consistent with ischemia or myocardial infarction.
• Diabetes (because of the generally accepted significant association with previously undiagnosed coronary artery disease).
• Peripheral vascular disease (because of the generally accepted significant association with previously undiagnosed coronary artery disease).
• History of prior allergy or sensitivity to any component of any formulation.
• Those taking medications of the following types or closely related medications:
• cyclosporins
• fibrates
• Azole antifungals
• macrolide antibiotics
• anti-arrhythmic medications
• Nefazodin
• protease inhibitors
• Coumadin
• Seizure medication
• Pre-randomization CPK greater than the upper limits of normal.
• History of hepatitis or unexplained elevation of transaminase LFTs.
• History of musculoskeletal condition with weakness or pain, i.e., arthritis, myositis, myalgia, fibromyalgia or PMR.
• Active cancer or vasculitis on therapy.
• Inability to provide informed consent.
• Premenopausal women, women who are pregnant, may become pregnant or nursing mothers will be excluded because of the unknown effects of nutraceuticals on the fetus or newborn.
• Any travel plans by the subject that would affect compliance with the study protocol.
• History of a seizure disorder.
• End stage renal disease (or renal failure).

Where it is running

• Mitchell Karl, M.D. -- Cardiology — Boca Raton, Florida, United States

Full record on ClinicalTrials.gov

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