Blood Pressure, Concentration Ability Impaired, Energy Supply; Deficiency, HDL Low, Immune Deficiency, Joint Instability, Lung Function Decreased, Quality of Life, Stress
Conditions
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.
Interventions
DIETARY_SUPPLEMENTStem Cell 100+
Open-Label 10-Component Dietary Supplement
Sponsors
Centagen, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Open-label field trial without a placebo.
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | Baseline and at an average of 15 weeks | Change in Heart Rate |
| Blood Pressure | Baseline and at an average of 15 weeks | Change in Systolic and Diastolic Blood Pressure |
| HDL Cholesterol | Baseline and at an average of 15 weeks | Change in HDL Cholesterol |
| Lung Capacity | Baseline and at an average of 15 weeks | Change in Peak Expiatory Flow |
| Stress Level | Baseline and at an average of 15 weeks | Change in Heart Rate Variability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cold/Flu Resistance | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 Health | 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 | 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) |
Countries
United States
Outcome results
None listed