Effects of a 10 Component Dietary Supplement on Health and the Quality of Life
2017년 2월 9일 업데이트: 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.
연구 개요
상태
완전한
개입 / 치료
상세 설명
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.
연구 유형
중재적
등록 (실제)
15
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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San Diego, California, 미국, 92121
- Accelagen, Inc.
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
35년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Stem Cell 100+ Intervention
Subjects take one 650 mg capsule by mouth twice daily for an average of 15 weeks
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Open-Label 10-Component Dietary Supplement
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Blood Pressure
기간: Baseline and at an average of 15 weeks
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Change in Systolic and Diastolic Blood Pressure
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Baseline and at an average of 15 weeks
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HDL Cholesterol
기간: Baseline and at an average of 15 weeks
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Change in HDL Cholesterol
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Baseline and at an average of 15 weeks
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Lung Capacity
기간: Baseline and at an average of 15 weeks
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Change in Peak Expiatory Flow
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Baseline and at an average of 15 weeks
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Stress Level
기간: Baseline and at an average of 15 weeks
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Change in Heart Rate Variability
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Baseline and at an average of 15 weeks
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Heart Rate
기간: Baseline and at an average of 15 weeks
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Change in Heart Rate
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Baseline and at an average of 15 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall Health
기간: From baseline through study completion, an average of 15 weeks
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Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
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From baseline through study completion, an average of 15 weeks
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Ability to Concentrate or Focus
기간: From baseline through study completion, an average of 15 weeks
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Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
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From baseline through study completion, an average of 15 weeks
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Joint Flexibility
기간: From baseline through study completion, an average of 15 weeks
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Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
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From baseline through study completion, an average of 15 weeks
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Work Productivity
기간: From baseline through study completion, an average of 15 weeks
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Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
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From baseline through study completion, an average of 15 weeks
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Ability to Relax
기간: From baseline through study completion, an average of 15 weeks
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Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
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From baseline through study completion, an average of 15 weeks
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Cold/Flu Resistance
기간: From baseline through study completion, an average of 15 weeks
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Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
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From baseline through study completion, an average of 15 weeks
|
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Stress Tolerance
기간: From baseline through study completion, an average of 15 weeks
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Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
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From baseline through study completion, an average of 15 weeks
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Energy Level
기간: From baseline through study completion, an average of 15 weeks
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Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
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From baseline through study completion, an average of 15 weeks
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Endurance
기간: From baseline through study completion, an average of 15 weeks
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Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
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From baseline through study completion, an average of 15 weeks
|
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Ease of Walking
기간: From baseline through study completion, an average of 15 weeks
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Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
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From baseline through study completion, an average of 15 weeks
|
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Climbing Stairs
기간: From baseline through study completion, an average of 15 weeks
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Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
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From baseline through study completion, an average of 15 weeks
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Overall Mood
기간: From baseline through study completion, an average of 15 weeks
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Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
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From baseline through study completion, an average of 15 weeks
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Vitality
기간: From baseline through study completion, an average of 15 weeks
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Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
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From baseline through study completion, an average of 15 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Bryant Villeponteau, Ph.D., Centagen, Inc.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 3월 12일
기본 완료 (실제)
2016년 8월 24일
연구 완료 (실제)
2016년 8월 24일
연구 등록 날짜
최초 제출
2017년 2월 8일
QC 기준을 충족하는 최초 제출
2017년 2월 9일
처음 게시됨 (실제)
2017년 2월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 2월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 2월 9일
마지막으로 확인됨
2017년 2월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .