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Nutrient Supplement
Study of Changes in Total Cholesterol Levels as a Function of Consuming a Supplement Designed to Improve Cardiovascular Health (AdBiotech Trial)
N/A
Waitlist Available
Led By Gilbert R Kaats, PhD FACN
Research Sponsored by Integrative Health Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 30, and 60 days
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.
Eligible Conditions
- High cholesterol
- High Cholesterol
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 30, and 60 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 30, and 60 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Blood Chemistry Measurements
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Ad-Chol-PreActive Control1 Intervention
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.
Group II: Half-dose Ad-Chol-PreActive Control1 Intervention
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.
Group III: Capsule containing inactive component of defatted egg yolkPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
Integrative Health Technologies, Inc.Lead Sponsor
5 Previous Clinical Trials
859 Total Patients Enrolled
Gilbert R Kaats, PhD FACNPrincipal InvestigatorIntegrative Health Technologies, Inc.
3 Previous Clinical Trials
435 Total Patients Enrolled
Harry G Preuss, MD MACNStudy ChairGeorgetown University Medical Center, Dept of Biochemistry, Medicine and Pathology
3 Previous Clinical Trials
435 Total Patients Enrolled
Sidney J Stohs, PhDStudy DirectorDean Emeritus, Creighton University Health Sciences Center
2 Previous Clinical Trials
235 Total Patients Enrolled