Clinical trial NCT03052491: Effects of a 10 Component Dietary Supplement on Health and the Quality of Life
Official title: Effects of a Multi-Pathway Dietary Supplement (Stem Cell 100+) on Indices of Health and Life Expectancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
HDL Low
Stress
Lung Function Decreased
Quality of Life
Energy Supply; Deficiency
Concentration Ability Impaired
Joint Instability
Immune Deficiency
Lead sponsor: Centagen, Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-14
Enrollment: 15
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label field trial without a placebo.
Primary purpose: PREVENTION

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.

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.

Eligibility 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
* 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

Primary outcomes:
measure: Blood Pressure
timeFrame: Baseline and at an average of 15 weeks
measure: HDL Cholesterol
timeFrame: Baseline and at an average of 15 weeks
measure: Lung Capacity
timeFrame: Baseline and at an average of 15 weeks
measure: Stress Level
timeFrame: Baseline and at an average of 15 weeks
measure: Heart Rate
timeFrame: Baseline and at an average of 15 weeks
Secondary outcomes:
measure: Overall Health
timeFrame: From baseline through study completion, an average of 15 weeks
measure: Ability to Concentrate or Focus
timeFrame: From baseline through study completion, an average of 15 weeks
measure: Joint Flexibility
timeFrame: From baseline through study completion, an average of 15 weeks
measure: Work Productivity
timeFrame: From baseline through study completion, an average of 15 weeks
measure: Ability to Relax
timeFrame: From baseline through study completion, an average of 15 weeks
measure: Cold/Flu Resistance
timeFrame: From baseline through study completion, an average of 15 weeks
measure: Stress Tolerance
timeFrame: From baseline through study completion, an average of 15 weeks
measure: Energy Level
timeFrame: From baseline through study completion, an average of 15 weeks
measure: Endurance
timeFrame: From baseline through study completion, an average of 15 weeks
measure: Ease of Walking
timeFrame: From baseline through study completion, an average of 15 weeks
measure: Climbing Stairs
timeFrame: From baseline through study completion, an average of 15 weeks
measure: Overall Mood
timeFrame: From baseline through study completion, an average of 15 weeks
measure: Vitality
timeFrame: From baseline through study completion, an average of 15 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Accelagen, Inc.
state: California
Study officials:
affiliation: Centagen, Inc.
name: Bryant Villeponteau, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. eCollection 2015.
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. doi: 10.1016/s0531-5565(00)00182-0.
citation: 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.
citation: 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.
citation: 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.