Clinical trial NCT01890889: Study of Changes in Total Cholesterol Levels as a Function of Consuming a Supplement Designed to Improve Cardiovascular Health
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholesterol
Hyperlipidemia
Hypercholesteremia
Keywords: Total Cholesterol
LDL
Lead sponsor: Integrative Health Technologies, Inc.
Sponsor class: NETWORK
First posted: 2013-07-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 two different functional-food supplements versus a placebo in a 60-day study.

Upon completion of the pre-study screening, and after having received an explanation of the requirements, risks and benefits, and completing the informed consent interview with the research coordinator, subjects will execute a written informed consent. Subjects will be randomly assigned to one of three study groups.

Relevant Background Information.

A factor leading to development of vascular disease, a leading cause of death in industrialized nations, is elevated serum cholesterol. It is estimated that 19% of Americans between the ages of 20 and 74 years of age have high serum cholesterol. However, in an analysis of 10,000 test results in our database from subjects similar to those who are likely to participate in this study, we found 37% of subjects had TC scores between 200 and 250 and 10.3% above 250.

The most prevalent form of vascular disease is arteriosclerosis, a condition associated with the thickening and hardening of the arterial wall. The regulation of whole-body cholesterol homeostasis involves the regulation of intestinal cholesterol absorption, cellular cholesterol trafficking, a modulation of cholesterol biosynthesis, bile acid biosynthesis, steroid biosynthesis and the catabolism of the cholesterol-containing plasma lipoproteins. Regulation of intestinal cholesterol absorption has proven to be an effective means by which to regulate serum cholesterol levels.

Ad-Chol-Pre (ACP) is a functional food ingredient designed to inhibit cholesterol absorption. ACP is a freeze dried defatted egg powder containing specific Anti-NPCIL1 (Niemann-Pick C1-like 1) IgY. NPC1L1 is known as a biological target of the cholesterol-uptake inhibitor, Ezetimibe. In previous unpublished pilot studies examining the safety and efficacy of ACP include:

* ACP was shown to produce a statistically inhibition of \[3H\]-Cholesterol absorption from 50 ug/ml (P\<0.05) in NPC1L1 over-expressing HepG2 cell lines as compared to an inhibition of 10ug/ml with Ezetimibe alone.
* I preliminary unpublished animal studies, ACP was shown to significantly inhibit radiolabelled cholesterol. ACP was found to significantly lower total cholesterol (38% \~56%) and LDL cholesterol (46\~57%) in bloods from animals fed who had been fed a high fat diet for 6 weeks.

Eligibility criteria: 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;

Primary outcomes:
measure: Change from baseline in Total Cholesterol and LDL levels at 30 days
timeFrame: 0 and 30 days
measure: Change from baseline in Total Cholesterol and LDL levels at 60 days
timeFrame: 0 and 60 days
measure: Change from mid-point in Total Cholesterol and LDL levels at 60 days
timeFrame: 30 and 60 days
Secondary outcomes:
measure: Blood Chemistry Measurements
timeFrame: 0, 30, and 60 days
measure: Self-reported Quality of Life
timeFrame: 0, 30, and 60 days
measure: Number of participants with adverse effects
timeFrame: up to 60 days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Integrative Health Technologies
state: Texas
Study officials:
affiliation: Integrative Health Technologies, Inc.
name: Gilbert R Kaats, PhD FACN
role: PRINCIPAL_INVESTIGATOR
affiliation: Georgetown University Medical Center, Dept of Biochemistry, Medicine and Pathology
name: Harry G Preuss, MD MACN
role: STUDY_CHAIR
affiliation: Dean Emeritus, Creighton University Health Sciences Center
name: Sidney J Stohs, PhD
role: STUDY_DIRECTOR
References: