Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 7 of 37 for:    Niemann Pick C

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2013 by Integrative Health Technologies, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Gilbert R Kaats, Integrative Health Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01890889
First received: June 27, 2013
Last updated: November 21, 2013
Last verified: November 2013
  Purpose
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.

Condition Intervention
Cholesterol
Hyperlipidemia
Hypercholesteremia
Dietary Supplement: Ad-Chol-Pre
Dietary Supplement: Half-dose Ad-Chol-Pre
Other: Defatted egg yolk without the active ingredient of the other two interventions

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
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

Resource links provided by NLM:


Further study details as provided by Integrative Health Technologies, Inc.:

Primary Outcome Measures:
  • Change from baseline in Total Cholesterol and LDL levels at 30 days [ Time Frame: 0 and 30 days ] [ Designated as safety issue: Yes ]
  • Change from baseline in Total Cholesterol and LDL levels at 60 days [ Time Frame: 0 and 60 days ] [ Designated as safety issue: Yes ]
  • Change from mid-point in Total Cholesterol and LDL levels at 60 days [ Time Frame: 30 and 60 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Blood Chemistry Measurements [ Time Frame: 0, 30, and 60 days ] [ Designated as safety issue: Yes ]
    Remaining lipids, Complete Blood Count, Metabolic Panel, Thyroid Stimulating Hormone, Cardio C-reactive Protein

  • Self-reported Quality of Life [ Time Frame: 0, 30, and 60 days ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse effects [ Time Frame: up to 60 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: July 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Anti-NPC1L1 IgY
  • Ezetimibe
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:
  • Ad-Chol-Pre
  • Anti-NPC1L1 IgY
  • Ezetimibe
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 Name: Capsule manufactured to mimic the Ad-Chol-Pre capsule, only not containing the active component.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01890889

Contacts
Contact: Patricia L Keith 210-824-4200 hmrcenterstudy@gmail.com

Locations
United States, Texas
Integrative Health Technologies Recruiting
San Antonio, Texas, United States, 78209
Contact: Patricia l Keith, BBA    210-824-4200    hmrcenterstudy@gmail.com   
Contact: Mike E Gale, BS    210-824-4200    hmrcenterstudy@gmail.com   
Sub-Investigator: Patricia L Keith, BBA         
Sub-Investigator: Samuel C Keith, BBA         
Sub-Investigator: Joel A Michalek, PhD         
Sub-Investigator: Harry A Croft, MD         
Sponsors and Collaborators
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
  More Information

Responsible Party: Gilbert R Kaats, Dr. Gilbert R. Kaats, PhD, Integrative Health Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01890889     History of Changes
Other Study ID Numbers: 065 
Study First Received: June 27, 2013
Last Updated: November 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Integrative Health Technologies, Inc.:
Total Cholesterol
LDL

Additional relevant MeSH terms:
Hyperlipidemias
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on September 29, 2016