- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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
Visão geral do estudo
Status
Condições
Descrição detalhada
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 In previous unpublished pilot studies examining the safety and efficacy of ACP include: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 estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Patricia L Keith
- Número de telefone: 210-824-4200
- E-mail: hmrcenterstudy@gmail.com
Locais de estudo
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Texas
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San Antonio, Texas, Estados Unidos, 78209
- Recrutamento
- Integrative Health Technologies
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Contato:
- Patricia l Keith, BBA
- Número de telefone: 210-824-4200
- E-mail: hmrcenterstudy@gmail.com
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Subinvestigador:
- Patricia L Keith, BBA
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Subinvestigador:
- Samuel C Keith, BBA
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Subinvestigador:
- Joel A Michalek, PhD
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Subinvestigador:
- Harry A Croft, MD
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Contato:
- Mike E Gale, BS
- Número de telefone: 210-824-4200
- E-mail: hmrcenterstudy@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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;
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: 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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Outros nomes:
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Comparador Ativo: 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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Outros nomes:
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Comparador de 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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Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Change from baseline in Total Cholesterol and LDL levels at 30 days
Prazo: 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
Prazo: 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
Prazo: 30 and 60 days
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30 and 60 days
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Blood Chemistry Measurements
Prazo: 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
Prazo: 0, 30, and 60 days
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0, 30, and 60 days
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Number of participants with adverse effects
Prazo: 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.
- Cadeira de estudo: Harry G Preuss, MD MACN, Georgetown University Medical Center, Dept of Biochemistry, Medicine and Pathology
- Diretor de estudo: Sidney J Stohs, PhD, Dean Emeritus, Creighton University Health Sciences Center
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 065
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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