Effects of a 10 Component Dietary Supplement on Health and the Quality of Life
Primary Purpose
Blood Pressure, HDL Low, Stress
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stem Cell 100+
Sponsored by
About this trial
This is an interventional prevention trial for Blood Pressure
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
Sites / Locations
- Accelagen, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stem Cell 100+ Intervention
Arm Description
Subjects take one 650 mg capsule by mouth twice daily for an average of 15 weeks
Outcomes
Primary Outcome Measures
Blood Pressure
Change in Systolic and Diastolic Blood Pressure
HDL Cholesterol
Change in HDL Cholesterol
Lung Capacity
Change in Peak Expiatory Flow
Stress Level
Change in Heart Rate Variability
Heart Rate
Change in Heart Rate
Secondary Outcome Measures
Overall Health
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Ability to Concentrate or Focus
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Joint Flexibility
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Work Productivity
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Ability to Relax
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Cold/Flu Resistance
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Stress Tolerance
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Energy Level
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Endurance
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Ease of Walking
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Climbing Stairs
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Overall Mood
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Vitality
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03052491
Brief Title
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 12, 2016 (Actual)
Primary Completion Date
August 24, 2016 (Actual)
Study Completion Date
August 24, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centagen, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, HDL Low, Stress, Lung Function Decreased, Quality of Life, Energy Supply; Deficiency, Concentration Ability Impaired, Joint Instability, Immune Deficiency
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open-label field trial without a placebo.
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stem Cell 100+ Intervention
Arm Type
Experimental
Arm Description
Subjects take one 650 mg capsule by mouth twice daily for an average of 15 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Stem Cell 100+
Other Intervention Name(s)
SC100+
Intervention Description
Open-Label 10-Component Dietary Supplement
Primary Outcome Measure Information:
Title
Blood Pressure
Description
Change in Systolic and Diastolic Blood Pressure
Time Frame
Baseline and at an average of 15 weeks
Title
HDL Cholesterol
Description
Change in HDL Cholesterol
Time Frame
Baseline and at an average of 15 weeks
Title
Lung Capacity
Description
Change in Peak Expiatory Flow
Time Frame
Baseline and at an average of 15 weeks
Title
Stress Level
Description
Change in Heart Rate Variability
Time Frame
Baseline and at an average of 15 weeks
Title
Heart Rate
Description
Change in Heart Rate
Time Frame
Baseline and at an average of 15 weeks
Secondary Outcome Measure Information:
Title
Overall Health
Description
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Time Frame
From baseline through study completion, an average of 15 weeks
Title
Ability to Concentrate or Focus
Description
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Time Frame
From baseline through study completion, an average of 15 weeks
Title
Joint Flexibility
Description
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Time Frame
From baseline through study completion, an average of 15 weeks
Title
Work Productivity
Description
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Time Frame
From baseline through study completion, an average of 15 weeks
Title
Ability to Relax
Description
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Time Frame
From baseline through study completion, an average of 15 weeks
Title
Cold/Flu Resistance
Description
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Time Frame
From baseline through study completion, an average of 15 weeks
Title
Stress Tolerance
Description
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Time Frame
From baseline through study completion, an average of 15 weeks
Title
Energy Level
Description
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Time Frame
From baseline through study completion, an average of 15 weeks
Title
Endurance
Description
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Time Frame
From baseline through study completion, an average of 15 weeks
Title
Ease of Walking
Description
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Time Frame
From baseline through study completion, an average of 15 weeks
Title
Climbing Stairs
Description
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Time Frame
From baseline through study completion, an average of 15 weeks
Title
Overall Mood
Description
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Time Frame
From baseline through study completion, an average of 15 weeks
Title
Vitality
Description
Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)
Time Frame
From baseline through study completion, an average of 15 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryant Villeponteau, Ph.D.
Organizational Affiliation
Centagen, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Accelagen, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25879540
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.
Results Reference
background
PubMed Identifier
11113618
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.
Results Reference
background
PubMed Identifier
9315443
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.
Results Reference
background
PubMed Identifier
9343401
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.
Results Reference
background
PubMed Identifier
7613096
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.
Results Reference
background
Links:
URL
http://en.wikipedia.org/wiki/Bryant_Villeponteau
Description
Wikipedia description of Villeponteau's contributions to science and medicine
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Effects of a 10 Component Dietary Supplement on Health and the Quality of Life
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