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

NCT01152073 | Completed DMC

• 1 other identifier: 2009.35
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hyperlipidemia

Keywords

Cholesterol; Statin; Nutraceuticals; Niacin; Hyperlipidemia; Liquid

Outcome Measures

Primary Outcomes (1)

• LDL Reduction

  The primary end point will be relative LDL and total cholesterol reductions, i.e., the placebo subtracted reduction in these parameters.

  8 weeks

Secondary Outcomes (3)

• HDL change from control formulation

  8 weeks

• CRP change from control formulation

  8 weeks

• Triglyceride reduction from control formulation

  8 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Study participants whose drink formulation contains no active ingredients but will appear and taste similar to the two other formulations. This will form the control formulation

Dietary Supplement: Placebo

Second Formulation

ACTIVE COMPARATOR

Study participants' drink formulation will include Red Yeast Rice 600mg, Niacin 12.5mg, Phytosterol esters 650mg, L-Carnitine 150mg, vitamin C 500mg, and Co-Q-10 25mg.

Dietary Supplement: Second Formulation

Third Formulation

ACTIVE COMPARATOR

The third formulation will be identical to the second, but without the Red Yeast Rice.

Dietary Supplement: Third Formulation

Interventions

Placebo DIETARY_SUPPLEMENT

Each subject will be expected to consume a twice daily drink of approximately 4 ounces per serving taken with the morning and evening meals for a total of 8 weeks. Each bottle will contain two servings.

Placebo

Second Formulation DIETARY_SUPPLEMENT

Each subject will be expected to consume a twice daily drink of approximately 4 ounces per serving taken with the morning and evening meals for a total of 8 weeks. Each bottle will contain two servings.

Second Formulation

Third Formulation DIETARY_SUPPLEMENT

Each subject will be expected to consume a twice daily drink of approximately 4 ounces per serving taken with the morning and evening meals for a total of 8 weeks. Each bottle will contain two servings.

Third Formulation

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Healthy Drink Discoveries, Inc.: lead

Study Sites (1)

Mitchell Karl, M.D. -- Cardiology

Boca Raton, Florida, 33486, United States

Location

Related Publications (25)

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MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mitchell Karl, M.D.

  Boca Raton Community Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: June 29, 2010
• Study Start: October 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 16, 2012

Record last verified: 2012-03

Locations

US (1)