CholesterolAdBiotechNCT01890889
Study of Changes in Total Cholesterol Levels as a Function of Consuming a Supplement Designed to Improve Cardiovascular Health
A study testing Ad-Chol-Pre, Half-dose Ad-Chol-Pre and Defatted egg yolk without the active ingredient of the other two interventions in people with Cholesterol and Hyperlipidemia, run by Integrative Health Technologies, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cholesterol, Hyperlipidemia, Hypercholesteremia
- What is being tested?
- Ad-Chol-Pre, Half-dose Ad-Chol-Pre and Defatted egg yolk without the active ingredient of the other two interventions
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Integrative Health Technologies
San Antonio, Texas, 78209
Patricia l Keith, BBA, 210-824-4200, hmrcenterstudy@gmail.com
Mike E Gale, BS, 210-824-4200, hmrcenterstudy@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Cholesterol, Hyperlipidemia, Hypercholesteremia
- Being tested
- Ad-Chol-Pre, Half-dose Ad-Chol-Pre, Defatted egg yolk without the active ingredient of the other two interventions
- Keywords
- Total Cholesterol, LDL
- Medical subject headings
- Hyperlipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad-Chol-PreDietary supplement
Also called Anti-NPC1L1 IgY, Ezetimibe
Half-dose Ad-Chol-PreDietary supplement
Also called Ad-Chol-Pre, Anti-NPC1L1 IgY, Ezetimibe
Defatted egg yolk without the active ingredient of the other two interventionsOther
Also called Capsule manufactured to mimic the Ad-Chol-Pre capsule, only not containing the active component.
| Study group | Role | What they receive |
|---|---|---|
| Ad-Chol-Pre | Active comparator | 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. Receives: Dietary Supplement: Ad-Chol-Pre |
| Half-dose Ad-Chol-Pre | Active comparator | 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. Receives: Dietary Supplement: Half-dose Ad-Chol-Pre |
| Capsule containing inactive component of defatted egg yolk | Placebo comparator | 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. Receives: Other: Defatted egg yolk without the active ingredient of the other two interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Total Cholesterol and LDL levels at 30 days
Measured: 0 and 30 days
Change from baseline in Total Cholesterol and LDL levels at 60 days
Measured: 0 and 60 days
Change from mid-point in Total Cholesterol and LDL levels at 60 days
Measured: 30 and 60 days
Secondary outcomes (3)
Blood Chemistry Measurements
Remaining lipids, Complete Blood Count, Metabolic Panel, Thyroid Stimulating Hormone, Cardio C-reactive Protein
Measured: 0, 30, and 60 days
Self-reported Quality of Life
Measured: 0, 30, and 60 days
Number of participants with adverse effects
Measured: up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionNov 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholesterolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Health Technologies, Inc.
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Gilbert R Kaats, Integrative Health Technologies, Inc.
- Investigators
- Gilbert R Kaats, PhD FACN, Principal investigator, Integrative Health Technologies, Inc.Harry G Preuss, MD MACN, Study chair, Georgetown University Medical Center, Dept of Biochemistry, Medicine and PathologySidney J Stohs, PhD, Study director, Dean Emeritus, Creighton University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890889
- Sponsor's protocol ID
- 065
- Acronym
- AdBiotech
- Status last verified
- Nov 2013
- First submitted
- 27 Jun 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01890889
- Acronym / sponsor ID
- AdBiotech / 065
- Conditions
- Cholesterol, Hyperlipidemia, Hypercholesteremia
- Keywords
- Total Cholesterol, LDL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Integrative Health Technologies, Inc.Research network
- Study start
- Jul 2013
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 2 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ad-Chol-Pre | Active comparator | Dietary Supplement: Ad-Chol-PreA 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 comparator | Dietary Supplement: Half-dose Ad-Chol-PreA 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 comparator | Other: Defatted egg yolk without the active ingredient of the other two interventionsPlacebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ad-Chol-PreAlso: Anti-NPC1L1 IgY, Ezetimibe | Dietary supplement | Ad-Chol-Pre |
| Half-dose Ad-Chol-PreAlso: Ad-Chol-Pre, Anti-NPC1L1 IgY, Ezetimibe | Dietary supplement | Half-dose Ad-Chol-Pre |
| Defatted egg yolk without the active ingredient of the other two interventionsAlso: Capsule manufactured to mimic the Ad-Chol-Pre capsule, only not containing the active component. | Other | Capsule containing inactive component of defatted egg yolk |
Primary outcome
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
3 secondary outcomes
Blood Chemistry Measurements
Time frame: 0, 30, and 60 days
Self-reported Quality of Life
Time frame: 0, 30, and 60 days
Number of participants with adverse effects
Time frame: up to 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilbert R Kaats, PhD FACN principal investigator
Integrative Health Technologies, Inc.
Harry G Preuss, MD MACN study chair
Georgetown University Medical Center, Dept of Biochemistry, Medicine and Pathology
Sidney J Stohs, PhD study director
Dean Emeritus, Creighton University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ad-Chol-Pre, Half-dose Ad-Chol-Pre and Defatted egg yolk without the active ingredient of the other two interventions in people with Cholesterol and Hyperlipidemia, run by Integrative Health Technologies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia L Keith (210-824-4200, hmrcenterstudy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Total Cholesterol and LDL levels at 30 days (time frame: 0 and 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.