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

Study Overview
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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.

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

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

Intervention / Treatment
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* Dietary Supplement: Stem Cell 100+


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Open-label field trial without a placebo.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem Cell 100+ Intervention<br>Subjects take one 650 mg capsule by mouth twice daily for an average of 15 weeks | Dietary Supplement: Stem Cell 100+<br>* Open-Label 10-Component Dietary Supplement<br>* Other names: SC100+;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Health | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |