Study of Changes in Total Cholesterol Levels as a Function of Consuming a Supplement Designed to Improve Cardiovascular Health (AdBiotech)

November 21, 2013 updated by: Gilbert R Kaats, Integrative Health Technologies, Inc.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78209
        • Recruiting
        • Integrative Health Technologies
        • Contact:
        • Sub-Investigator:
          • Patricia L Keith, BBA
        • Sub-Investigator:
          • Samuel C Keith, BBA
        • Sub-Investigator:
          • Joel A Michalek, PhD
        • Sub-Investigator:
          • Harry A Croft, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ad-Chol-Pre
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.
Dietary supplement: Ad-Chol-Pre
Other Names:
  • Ezetimibe
  • Anti-NPC1L1 IgY
Active Comparator: Half-dose Ad-Chol-Pre
A half-dose of the active comparator in arm one is administered. 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.
Dietary supplement: Half-dose Ad-Chol-Pre
Other Names:
  • Ezetimibe
  • Anti-NPC1L1 IgY
  • Ad-Chol-Pre
Placebo Comparator: Capsule containing inactive component of defatted egg yolk
Placebo capsule is filled with defat egg yolk only without specific IgY which is anti-NPC1L1 IgY, designed to look and taste the same as the active product capsule, but does not contain the active component.
Other: Defatted egg yolk without the active ingredient of the other two interventions
Other Names:
  • Capsule manufactured to mimic the Ad-Chol-Pre capsule, only not containing the active component.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Total Cholesterol and LDL levels at 30 days
Time Frame: 0 and 30 days
0 and 30 days
Change from baseline in Total Cholesterol and LDL levels at 60 days
Time Frame: 0 and 60 days
0 and 60 days
Change from mid-point in Total Cholesterol and LDL levels at 60 days
Time Frame: 30 and 60 days
30 and 60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Chemistry Measurements
Time Frame: 0, 30, and 60 days
Remaining lipids, Complete Blood Count, Metabolic Panel, Thyroid Stimulating Hormone, Cardio C-reactive Protein
0, 30, and 60 days
Self-reported Quality of Life
Time Frame: 0, 30, and 60 days
0, 30, and 60 days
Number of participants with adverse effects
Time Frame: up to 60 days
up to 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Integrative Health Technologies, Inc.

Investigators

  • Principal Investigator: Gilbert R Kaats, PhD FACN, Integrative Health Technologies, Inc.
  • Study Chair: Harry G Preuss, MD MACN, Georgetown University Medical Center, Dept of Biochemistry, Medicine and Pathology
  • Study Director: Sidney J Stohs, PhD, Dean Emeritus, Creighton University Health Sciences Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

November 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

June 27, 2013

First Submitted That Met QC Criteria

June 27, 2013

First Posted (Estimate)

July 2, 2013

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 21, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 065

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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