- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01890889
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
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 In previous unpublished pilot studies examining the safety and efficacy of ACP include: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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Patricia L Keith
- Numero di telefono: 210-824-4200
- Email: hmrcenterstudy@gmail.com
Luoghi di studio
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Texas
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San Antonio, Texas, Stati Uniti, 78209
- Reclutamento
- Integrative Health Technologies
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Contatto:
- Patricia l Keith, BBA
- Numero di telefono: 210-824-4200
- Email: hmrcenterstudy@gmail.com
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Sub-investigatore:
- Patricia L Keith, BBA
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Sub-investigatore:
- Samuel C Keith, BBA
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Sub-investigatore:
- Joel A Michalek, PhD
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Sub-investigatore:
- Harry A Croft, MD
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Contatto:
- Mike E Gale, BS
- Numero di telefono: 210-824-4200
- Email: hmrcenterstudy@gmail.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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;
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore attivo: 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.
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Altri nomi:
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Comparatore attivo: 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.
|
Altri nomi:
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Comparatore placebo: 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.
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Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Change from baseline in Total Cholesterol and LDL levels at 30 days
Lasso di tempo: 0 and 30 days
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0 and 30 days
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Change from baseline in Total Cholesterol and LDL levels at 60 days
Lasso di tempo: 0 and 60 days
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0 and 60 days
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Change from mid-point in Total Cholesterol and LDL levels at 60 days
Lasso di tempo: 30 and 60 days
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30 and 60 days
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Blood Chemistry Measurements
Lasso di tempo: 0, 30, and 60 days
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Remaining lipids, Complete Blood Count, Metabolic Panel, Thyroid Stimulating Hormone, Cardio C-reactive Protein
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0, 30, and 60 days
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Self-reported Quality of Life
Lasso di tempo: 0, 30, and 60 days
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0, 30, and 60 days
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Number of participants with adverse effects
Lasso di tempo: up to 60 days
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up to 60 days
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Gilbert R Kaats, PhD FACN, Integrative Health Technologies, Inc.
- Cattedra di studio: Harry G Preuss, MD MACN, Georgetown University Medical Center, Dept of Biochemistry, Medicine and Pathology
- Direttore dello studio: Sidney J Stohs, PhD, Dean Emeritus, Creighton University Health Sciences Center
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 065
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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