Effects of a 10 Component Dietary Supplement on Health and the Quality of Life

Quality of Life Clinical Trial

Official title:

Effects of a Multi-Pathway Dietary Supplement (Stem Cell 100+) on Indices of Health and Life Expectancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03052491
• Other study ID #: SC100+ Clinical #1
• 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
• 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

Related Conditions & MeSH terms

• Blood Pressure
• Concentration Ability Impaired
• Energy Supply; Deficiency
• HDL Low
• Immune Deficiency
• Immunologic Deficiency Syndromes
• Joint Instability
• Lung Function Decreased
• Protein-Energy Malnutrition
• Quality of Life
• Stress

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

External Links

•   Centagen, Inc. Website
•   Wikipedia description of Villeponteau's contributions to science and medicine