Effects of a 10 Component Dietary Supplement on Health and the Quality of Life
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Stem Cell 100+ Intervention Subjects take one 650 mg capsule by mouth twice daily for an average of 15 weeks |
Dietary Supplement: Stem Cell 100+
Open-Label 10-Component Dietary Supplement
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Blood Pressure [Baseline and at an average of 15 weeks]
Change in Systolic and Diastolic Blood Pressure
- HDL Cholesterol [Baseline and at an average of 15 weeks]
Change in HDL Cholesterol
- Lung Capacity [Baseline and at an average of 15 weeks]
Change in Peak Expiatory Flow
- Stress Level [Baseline and at an average of 15 weeks]
Change in Heart Rate Variability
- Heart Rate [Baseline and at an average of 15 weeks]
Change in Heart Rate
Secondary Outcome Measures
- Overall Health [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)
- Ability to Concentrate or Focus [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)
- Joint Flexibility [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)
- Work Productivity [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)
- Ability to Relax [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)
- Cold/Flu Resistance [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)
- Stress Tolerance [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)
- Energy Level [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)
- Endurance [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)
- Ease of Walking [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)
- Climbing Stairs [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)
- Overall Mood [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)
- Vitality [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)
Eligibility Criteria
Criteria
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
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Willing to submit to evaluation testing of blood pressure, lung testing, stress testing.
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Willing to take online self reported survey of health at end of trial
Exclusion Criteria:
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History of metastatic cancer, heart attack, dementia, or other life-threatening disease
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Any subject who is not capable of responding to a self-reported online questionnaire
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Pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Accelagen, Inc. | San Diego | California | United States | 92121 |
Sponsors and Collaborators
- Centagen, Inc.
Investigators
- Principal Investigator: Bryant Villeponteau, Ph.D., Centagen, Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Harley CB, Villeponteau B. Telomeres and telomerase in aging and cancer. Curr Opin Genet Dev. 1995 Apr;5(2):249-55. Review.
- MarusÃc 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.
- 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.
- 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. The heterochromatin loss model of aging. Exp Gerontol. 1997 Jul-Oct;32(4-5):383-94. Review.
- SC100+ Clinical #1