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

NCT ID: NCT03052491

Last Updated: 2017-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-12

Study Completion Date

2016-08-24

Brief Summary

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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

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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.

Conditions

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Blood Pressure HDL Low Stress Lung Function Decreased Quality of Life Energy Supply; Deficiency Concentration Ability Impaired Joint Instability Immune Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open-label field trial without a placebo.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Stem Cell 100+ Intervention

Subjects take one 650 mg capsule by mouth twice daily for an average of 15 weeks

Group Type EXPERIMENTAL

Stem Cell 100+

Intervention Type DIETARY_SUPPLEMENT

Open-Label 10-Component Dietary Supplement

Interventions

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Stem Cell 100+

Open-Label 10-Component Dietary Supplement

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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SC100+

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centagen, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bryant Villeponteau, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Centagen, Inc.

Locations

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Accelagen, Inc.

San Diego, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25879540 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11113618 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9315443 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9343401 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7613096 (View on PubMed)

Related Links

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http://en.wikipedia.org/wiki/Bryant_Villeponteau

Wikipedia description of Villeponteau's contributions to science and medicine

Other Identifiers

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SC100+ Clinical #1

Identifier Type: -

Identifier Source: org_study_id

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