Recruiting

Cardiovascular Supplement

Sponsor:

Integrative Health Technologies, Inc.

Code:

NCT01890889

Conditions

Cholesterol

Hyperlipidemia

Hypercholesteremia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Ad-Chol-Pre

Half-dose Ad-Chol-Pre

Defatted egg yolk without the active ingredient of the other two interventions

Study Details

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.

Conditions

Cholesterol

Hyperlipidemia

Hypercholesteremia

Study ID

NCT01890889

Start date

Jul, 2013

Status verified date

Nov, 2013

Completion date

Dec, 2013

Anticipated

Primary completion date

Nov, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

Ad-Chol-Pre

Half-dose Ad-Chol-Pre

Defatted egg yolk without the active ingredient of the other two interventions

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Patricia L Keith

210-824-4200hmrcenterstudy@gmail.com

Locations

Integrative Health Technologies

Recruiting

San Antonio, Texas, United States, 78209

Contacts

Patricia l Keith, BBA

210-824-4200hmrcenterstudy@gmail.com

Mike E Gale, BS

210-824-4200hmrcenterstudy@gmail.com

More Information

Sponsor

Integrative Health Technologies, Inc.

Last update posted

Nov 25, 2013

Last verified

Nov, 2013

Keywords

  • Total Cholesterol
  • LDL

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Integrative Health Technologies, Inc. on 2013-11-25.