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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Mitchell Karl, Healthy Drink Discoveries, Inc.
ClinicalTrials.gov Identifier:
NCT01152073
First received: June 25, 2010
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Hyperlipidemia
Dietary Supplement: Placebo
Dietary Supplement: Second Formulation
Dietary Supplement: Third Formulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Multicenter Study Of Nutraceutical Drinks For Cholesterol (Evaluating Effectiveness and Tolerability)

Resource links provided by NLM:


Further study details as provided by Healthy Drink Discoveries, Inc.:

Primary Outcome Measures:
  • LDL Reduction [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The primary end point will be relative LDL and total cholesterol reductions, i.e., the placebo subtracted reduction in these parameters.


Secondary Outcome Measures:
  • HDL change from control formulation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Secondary end points will include change from the control formulation with regard to HDL.

  • CRP change from control formulation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Secondary end points will include change from the control formulation with regard to CRP.

  • Triglyceride reduction from control formulation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Secondary end points will include change from the control formulation with regard to triglyceride levels.


Enrollment: 79
Study Start Date: October 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
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
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.
Active Comparator: Second Formulation
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
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.
Active Comparator: Third Formulation
The third formulation will be identical to the second, but without the Red Yeast Rice.
Dietary Supplement: Third Formulation
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All subjects will need to be on their usual diet and

  1. 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.
  2. 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,.
  3. Males 20 to 80 years of age will be acceptable.
  4. Post menopausal females 55 to 80 years of age.

Exclusion Criteria:

  1. Prior myocardial infarction clinically or by EKG criteria including left bundle branch block.
  2. History of angina.
  3. History of abnormal stress test consistent with ischemia or myocardial infarction.
  4. Diabetes (because of the generally accepted significant association with previously undiagnosed coronary artery disease).
  5. Peripheral vascular disease (because of the generally accepted significant association with previously undiagnosed coronary artery disease).
  6. History of prior allergy or sensitivity to any component of any formulation.
  7. Those taking medications of the following types or closely related medications:

    1. cyclosporins
    2. fibrates
    3. Azole antifungals
    4. macrolide antibiotics
    5. anti-arrhythmic medications
    6. Nefazodin
    7. protease inhibitors
    8. Coumadin
    9. Seizure medication
  8. Pre-randomization CPK greater than the upper limits of normal.
  9. History of hepatitis or unexplained elevation of transaminase LFTs.
  10. History of musculoskeletal condition with weakness or pain, i.e., arthritis, myositis, myalgia, fibromyalgia or PMR.
  11. Active cancer or vasculitis on therapy.
  12. Inability to provide informed consent.
  13. 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.
  14. Any travel plans by the subject that would affect compliance with the study protocol.
  15. History of a seizure disorder.
  16. End stage renal disease (or renal failure).
  17. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152073

Locations
United States, Florida
Mitchell Karl, M.D. -- Cardiology
Boca Raton, Florida, United States, 33486
Sponsors and Collaborators
Healthy Drink Discoveries, Inc.
Investigators
Principal Investigator: Mitchell Karl, M.D. Boca Raton Community Hospital
  More Information

Publications:
Baens-Arcega, L., Ardischer, AG et al. Indigenous Amino Acid/Peptide Sauces and Pastes with Meat-Like Flavors, Chinese Soy Sauces, Japanese, Shoyu, Japanese Miso, Southeast Asian Fish Sauces and Pastes and Related Fermented Foods in: Steinkraus, ED Handbook of Indigenous Fermented Food, 2nd edition, New York, NY, Marcel Dekker, Inc., 1986. Pg 625-633.
Diaz, et al, L-Carnitine Induced Modulation of Plasma Fatty Acid Metabolism, Rev Electron J. BioMed 2006; 1:33.

Responsible Party: Dr. Mitchell Karl, Principal Investigator, Healthy Drink Discoveries, Inc.
ClinicalTrials.gov Identifier: NCT01152073     History of Changes
Other Study ID Numbers: 2009.35
Study First Received: June 25, 2010
Last Updated: March 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Healthy Drink Discoveries, Inc.:
Cholesterol
Statin
Nutraceuticals
Niacin
Hyperlipidemia
Liquid

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 27, 2014