Study of Changes in Total Cholesterol Levels as a Function of Consuming a Supplement Designed to Improve Cardiovascular Health
AdBiotech
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
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedFirst Posted
Study publicly available on registry
July 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedNovember 25, 2013
November 1, 2013
4 months
June 27, 2013
November 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change from baseline in Total Cholesterol and LDL levels at 30 days
0 and 30 days
Change from baseline in Total Cholesterol and LDL levels at 60 days
0 and 60 days
Change from mid-point in Total Cholesterol and LDL levels at 60 days
30 and 60 days
Secondary Outcomes (3)
Blood Chemistry Measurements
0, 30, and 60 days
Self-reported Quality of Life
0, 30, and 60 days
Number of participants with adverse effects
up to 60 days
Study Arms (3)
Ad-Chol-Pre
ACTIVE COMPARATORA 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.
Half-dose Ad-Chol-Pre
ACTIVE COMPARATORA 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.
Capsule containing inactive component of defatted egg yolk
PLACEBO COMPARATORPlacebo 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Integrative Health Technologies
San Antonio, Texas, 78209, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Gilbert R. Kaats, PhD
Study Record Dates
First Submitted
June 27, 2013
First Posted
July 2, 2013
Study Start
July 1, 2013
Primary Completion
November 1, 2013
Study Completion
December 1, 2013
Last Updated
November 25, 2013
Record last verified: 2013-11