Status:
UNKNOWN
Study of Changes in Total Cholesterol Levels as a Function of Consuming a Supplement Designed to Improve Cardiovascular Health
Lead Sponsor:
Integrative Health Technologies, Inc.
Conditions:
Cholesterol
Hyperlipidemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
To evaluate the safety and efficacy of a food-source nutrient by comparing changes in total cholesterol levels, 44 other blood chemistries, and self-reported quality of life as a function of consuming...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01890889
Start Date
July 1 2013
End Date
December 1 2013
Last Update
November 25 2013
Active Locations (1)
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1
Integrative Health Technologies
San Antonio, Texas, United States, 78209