Hyperlipidemia Clinical Trial
— AdBiotechOfficial title:
A Double-blinded, Placebo-controlled Randomized Trial Assessing the Extent to Which Consumption of Two Different Amounts of a Non-Pharmaceutical Food Supplement Can Improve Cardiovascular Health
The purpose of this study is to evaluate the effectiveness of a food-source nutrient containing bitter orange by comparing changes 45 blood chemistries and self-reported quality of life.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - be an English-speaking male or female at least 18 years of age; - have a total cholesterol level between 200 mg/dL and 250mg/dL - have a LDL level between 100 mg/dL and 160 mg/dL - not have allergic reactions to eggs or egg products - not have consumed cholesterol-lowering drugs within 2 months of starting the study - agree to follow the requirements of the study as set forth in this Informed Consent - agree to withdraw from the study if becoming pregnant during the study. Exclusion Criteria: - do not speak English; - are under 18 years of age; - have a total cholesterol level below 200 mg/dL or above 250 mg/dL - have a LDL level below 100 mg/dL or above 160 mg/dL - have allergic reactions to eggs or egg products - have consumed cholesterol-lowering drugs within 2 months of starting the study - are pregnant or nursing; |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
Country | Name | City | State |
---|---|---|---|
United States | Integrative Health Technologies | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Integrative Health Technologies, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in Total Cholesterol and LDL levels at 30 days | 0 and 30 days | Yes | |
Primary | Change from baseline in Total Cholesterol and LDL levels at 60 days | 0 and 60 days | Yes | |
Primary | Change from mid-point in Total Cholesterol and LDL levels at 60 days | 30 and 60 days | Yes | |
Secondary | Blood Chemistry Measurements | Remaining lipids, Complete Blood Count, Metabolic Panel, Thyroid Stimulating Hormone, Cardio C-reactive Protein | 0, 30, and 60 days | Yes |
Secondary | Self-reported Quality of Life | 0, 30, and 60 days | Yes | |
Secondary | Number of participants with adverse effects | up to 60 days | Yes |
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