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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Centagen, Inc.

Current Primary Outcome:

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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)
• 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)
• 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)
• 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)
• 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)
• 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)
• 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)
• 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)
• 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)
• 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)
• 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)
• 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)
• 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)

Original Secondary Outcome: Same as current

Information By: Centagen, Inc.

Dates:
Date Received: February 8, 2017
Date Started: March 12, 2016
Date Completion:
Last Updated: February 9, 2017
Last Verified: February 2017