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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 In previous unpublished pilot studies examining the safety and efficacy of ACP include: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 de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Texas
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San Antonio, Texas, Estados Unidos, 78209
- Reclutamiento
- Integrative Health Technologies
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Contacto:
- Patricia l Keith, BBA
- Número de teléfono: 210-824-4200
- Correo electrónico: hmrcenterstudy@gmail.com
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Sub-Investigador:
- Patricia L Keith, BBA
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Sub-Investigador:
- Samuel C Keith, BBA
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Sub-Investigador:
- Joel A Michalek, PhD
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Sub-Investigador:
- Harry A Croft, MD
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Contacto:
- Mike E Gale, BS
- Número de teléfono: 210-824-4200
- Correo electrónico: hmrcenterstudy@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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;
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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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Otros nombres:
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Comparador activo: 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.
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Otros nombres:
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Comparador de placebos: 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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Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change from baseline in Total Cholesterol and LDL levels at 30 days
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 30 and 60 days
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30 and 60 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Blood Chemistry Measurements
Periodo de tiempo: 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
Periodo de tiempo: 0, 30, and 60 days
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0, 30, and 60 days
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Number of participants with adverse effects
Periodo de tiempo: up to 60 days
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up to 60 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gilbert R Kaats, PhD FACN, Integrative Health Technologies, Inc.
- Silla de estudio: Harry G Preuss, MD MACN, Georgetown University Medical Center, Dept of Biochemistry, Medicine and Pathology
- Director de estudio: Sidney J Stohs, PhD, Dean Emeritus, Creighton University Health Sciences Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 065
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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