Effects of a 10 Component Dietary Supplement on Health and the Quality of Life
9 de fevereiro de 2017 atualizado por: Centagen, Inc.
Effects of a Multi-Pathway Dietary Supplement (Stem Cell 100+) on Indices of Health and Life Expectancy
This open-label field trial evaluates the effects of treatment with a multi-pathway dietary supplement (Stem Cell 100+) that has been commercially available for several years.
The objective of the intervention trial is to determine if normal subjects over 35 years of age experience any observable health benefits from the dietary supplement as to their blood pressure, pulse rate, blood cholesterol, lung capacity, stress levels, or self reported changes in markers of overall health and life expectancy.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Currently, only dietary restriction has been verified to slow the rate of aging and to promote general health. This trial is designed to see whether a complex supplement (Stem Cell 100+) that targets multiple longevity pathways could also have positive effects on several markers of successful aging and good health. Multipath causes of aging include: stem cell function, telomere loss, chronic stress, inflammation, insulin-like growth factors, autophagy, vascular loss, neural dysfunction, and oxidative stress. The goal of the study was to test the effects of this novel multipath intervention strategy in a clinical trial of healthy people using health markers such as blood pressure, cholesterol status, lung function, stress levels, and self-reported health status. Hundreds of published animal and human clinical studies have been done with each of the individual active ingredients in the formulation, which target many critical causes of aging.
Based on their published animal studies showing extension of life span in a model animal and their laboratory work on adult human stem cells, the investigators believe that Stem Cell 100+ will provide evidence of efficacy in addressing multiple index markers of health and life expectancy outcomes.
Tipo de estudo
Intervencional
Inscrição (Real)
15
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
California
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San Diego, California, Estados Unidos, 92121
- Accelagen, Inc.
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
35 anos a 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- No history of serious cardiovascular, cancer, or neural disease.
- Normal health for age
- Willing to have blood drawn at baseline and after trial
- Willing to submit to evaluation testing of blood pressure, lung testing, stress testing.
- Willing to take online self reported survey of health at end of trial
Exclusion Criteria:
- History of metastatic cancer, heart attack, dementia, or other life-threatening disease
- Any subject who is not capable of responding to a self-reported online questionnaire
- Pregnant
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Stem Cell 100+ Intervention
Subjects take one 650 mg capsule by mouth twice daily for an average of 15 weeks
|
Open-Label 10-Component Dietary Supplement
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Blood Pressure
Prazo: Baseline and at an average of 15 weeks
|
Change in Systolic and Diastolic Blood Pressure
|
Baseline and at an average of 15 weeks
|
|
HDL Cholesterol
Prazo: Baseline and at an average of 15 weeks
|
Change in HDL Cholesterol
|
Baseline and at an average of 15 weeks
|
|
Lung Capacity
Prazo: Baseline and at an average of 15 weeks
|
Change in Peak Expiatory Flow
|
Baseline and at an average of 15 weeks
|
|
Stress Level
Prazo: Baseline and at an average of 15 weeks
|
Change in Heart Rate Variability
|
Baseline and at an average of 15 weeks
|
|
Heart Rate
Prazo: Baseline and at an average of 15 weeks
|
Change in Heart Rate
|
Baseline and at an average of 15 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall Health
Prazo: From baseline through study completion, an average of 15 weeks
|
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
|
From baseline through study completion, an average of 15 weeks
|
|
Ability to Concentrate or Focus
Prazo: From baseline through study completion, an average of 15 weeks
|
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
|
From baseline through study completion, an average of 15 weeks
|
|
Joint Flexibility
Prazo: From baseline through study completion, an average of 15 weeks
|
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
|
From baseline through study completion, an average of 15 weeks
|
|
Work Productivity
Prazo: From baseline through study completion, an average of 15 weeks
|
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
|
From baseline through study completion, an average of 15 weeks
|
|
Ability to Relax
Prazo: From baseline through study completion, an average of 15 weeks
|
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
|
From baseline through study completion, an average of 15 weeks
|
|
Cold/Flu Resistance
Prazo: From baseline through study completion, an average of 15 weeks
|
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
|
From baseline through study completion, an average of 15 weeks
|
|
Stress Tolerance
Prazo: From baseline through study completion, an average of 15 weeks
|
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
|
From baseline through study completion, an average of 15 weeks
|
|
Energy Level
Prazo: From baseline through study completion, an average of 15 weeks
|
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
|
From baseline through study completion, an average of 15 weeks
|
|
Endurance
Prazo: From baseline through study completion, an average of 15 weeks
|
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
|
From baseline through study completion, an average of 15 weeks
|
|
Ease of Walking
Prazo: From baseline through study completion, an average of 15 weeks
|
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
|
From baseline through study completion, an average of 15 weeks
|
|
Climbing Stairs
Prazo: From baseline through study completion, an average of 15 weeks
|
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
|
From baseline through study completion, an average of 15 weeks
|
|
Overall Mood
Prazo: From baseline through study completion, an average of 15 weeks
|
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
|
From baseline through study completion, an average of 15 weeks
|
|
Vitality
Prazo: From baseline through study completion, an average of 15 weeks
|
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
|
From baseline through study completion, an average of 15 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Bryant Villeponteau, Ph.D., Centagen, Inc.
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Villeponteau B, Matsagas K, Nobles AC, Rizza C, Horwitz M, Benford G, Mockett RJ. Herbal supplement extends life span under some environmental conditions and boosts stress resistance. PLoS One. 2015 Apr 16;10(4):e0119068. doi: 10.1371/journal.pone.0119068. eCollection 2015.
- Villeponteau B, Cockrell R, Feng J. Nutraceutical interventions may delay aging and the age-related diseases. Exp Gerontol. 2000 Dec;35(9-10):1405-17. doi: 10.1016/s0531-5565(00)00182-0.
- Villeponteau B. The heterochromatin loss model of aging. Exp Gerontol. 1997 Jul-Oct;32(4-5):383-94. doi: 10.1016/s0531-5565(96)00155-6.
- Marusic L, Anton M, Tidy A, Wang P, Villeponteau B, Bacchetti S. Reprogramming of telomerase by expression of mutant telomerase RNA template in human cells leads to altered telomeres that correlate with reduced cell viability. Mol Cell Biol. 1997 Nov;17(11):6394-401. doi: 10.1128/MCB.17.11.6394.
- Harley CB, Villeponteau B. Telomeres and telomerase in aging and cancer. Curr Opin Genet Dev. 1995 Apr;5(2):249-55. doi: 10.1016/0959-437x(95)80016-6.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
12 de março de 2016
Conclusão Primária (Real)
24 de agosto de 2016
Conclusão do estudo (Real)
24 de agosto de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
8 de fevereiro de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de fevereiro de 2017
Primeira postagem (Real)
14 de fevereiro de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de fevereiro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de fevereiro de 2017
Última verificação
1 de fevereiro de 2017
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SC100+ Clinical #1
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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