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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03052491
Other study ID # SC100+ Clinical #1
Secondary ID
Status Completed
Phase N/A
First received February 8, 2017
Last updated February 9, 2017
Start date March 12, 2016
Est. completion date August 24, 2016

Study information

Verified date February 2017
Source Centagen, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date August 24, 2016
Est. primary completion date August 24, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 80 Years
Eligibility 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

Study Design


Intervention

Dietary Supplement:
Stem Cell 100+
Open-Label 10-Component Dietary Supplement

Locations

Country Name City State
United States Accelagen, Inc. San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Centagen, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (5)

Harley CB, Villeponteau B. Telomeres and telomerase in aging and cancer. Curr Opin Genet Dev. 1995 Apr;5(2):249-55. Review. — View Citation

Marusíc 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. — View Citation

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. — View Citation

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. — View Citation

Villeponteau B. The heterochromatin loss model of aging. Exp Gerontol. 1997 Jul-Oct;32(4-5):383-94. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Blood Pressure Change in Systolic and Diastolic Blood Pressure Baseline and at an average of 15 weeks
Primary HDL Cholesterol Change in HDL Cholesterol Baseline and at an average of 15 weeks
Primary Lung Capacity Change in Peak Expiatory Flow Baseline and at an average of 15 weeks
Primary Stress Level Change in Heart Rate Variability Baseline and at an average of 15 weeks
Primary Heart Rate Change in Heart Rate Baseline and at an average of 15 weeks
Secondary Overall Health 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
Secondary Ability to Concentrate or Focus 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
Secondary Joint Flexibility 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
Secondary Work Productivity 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
Secondary Ability to Relax 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
Secondary Cold/Flu Resistance 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
Secondary Stress Tolerance 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
Secondary Energy Level 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
Secondary Endurance 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
Secondary Ease of Walking 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
Secondary Climbing Stairs 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
Secondary Overall Mood 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
Secondary Vitality 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
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