Status:
COMPLETED
A Study Of Nutraceutical Drinks For Cholesterol (Evaluating Effectiveness and Tolerability)
Lead Sponsor:
Healthy Drink Discoveries, Inc.
Conditions:
Hyperlipidemia
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
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 tho...
Detailed Description
Cholesterol is the principle component of cardiovascular disease. It deposits in the walls of blood vessels and contributes to both chronic vascular insufficiency manifested as claudication, ischemic ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
- Any subject who the investigator determines that discontinuing current cholesterol lowering treatment for the 16 weeks (8 weeks each for a wash out and study participation) of the study would not be safe or otherwise in the best interest of the subject.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT01152073
Start Date
October 1 2009
End Date
September 1 2010
Last Update
March 16 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mitchell Karl, M.D. -- Cardiology
Boca Raton, Florida, United States, 33486