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

February 9, 2017 updated by: Centagen, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92121
        • Accelagen, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • SC100+

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: Baseline and at an average of 15 weeks
Change in Systolic and Diastolic Blood Pressure
Baseline and at an average of 15 weeks
HDL Cholesterol
Time Frame: Baseline and at an average of 15 weeks
Change in HDL Cholesterol
Baseline and at an average of 15 weeks
Lung Capacity
Time Frame: Baseline and at an average of 15 weeks
Change in Peak Expiatory Flow
Baseline and at an average of 15 weeks
Stress Level
Time Frame: Baseline and at an average of 15 weeks
Change in Heart Rate Variability
Baseline and at an average of 15 weeks
Heart Rate
Time Frame: Baseline and at an average of 15 weeks
Change in Heart Rate
Baseline and at an average of 15 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Health
Time Frame: 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)
From baseline through study completion, an average of 15 weeks
Ability to Concentrate or Focus
Time Frame: 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)
From baseline through study completion, an average of 15 weeks
Joint Flexibility
Time Frame: 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)
From baseline through study completion, an average of 15 weeks
Work Productivity
Time Frame: 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)
From baseline through study completion, an average of 15 weeks
Ability to Relax
Time Frame: 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)
From baseline through study completion, an average of 15 weeks
Cold/Flu Resistance
Time Frame: 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)
From baseline through study completion, an average of 15 weeks
Stress Tolerance
Time Frame: 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)
From baseline through study completion, an average of 15 weeks
Energy Level
Time Frame: 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)
From baseline through study completion, an average of 15 weeks
Endurance
Time Frame: 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)
From baseline through study completion, an average of 15 weeks
Ease of Walking
Time Frame: 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)
From baseline through study completion, an average of 15 weeks
Climbing Stairs
Time Frame: 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)
From baseline through study completion, an average of 15 weeks
Overall Mood
Time Frame: 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)
From baseline through study completion, an average of 15 weeks
Vitality
Time Frame: 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)
From baseline through study completion, an average of 15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centagen, Inc.

Investigators

  • Principal Investigator: Bryant Villeponteau, Ph.D., Centagen, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2016

Primary Completion (Actual)

August 24, 2016

Study Completion (Actual)

August 24, 2016

Study Registration Dates

First Submitted

February 8, 2017

First Submitted That Met QC Criteria

February 9, 2017

First Posted (Actual)

February 14, 2017

Study Record Updates

Last Update Posted (Actual)

February 14, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC100+ Clinical #1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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