CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 79 enrolled
Drug / intervention
Placebo +2 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01152073
NCT01152073N/ACompleted

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

Healthy Drink Discoveries, Inc.·interventional·Posted Jun 29, 2010·Updated Mar 16, 2012

In Brief

A clinical study evaluating Placebo, Second Formulation, and 1 other intervention for Hyperlipidemia. Completed, enrolled 79 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 29, 2010
Enrollment StartOct 1, 2009
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.0 years ago

Interventions

Placebodietary

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 Formulationdietary

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 Formulationdietary

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.