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Completed

NCT Number: NCT03052491

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

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.

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Key information

Conditions

Blood Pressure Concentration Ability Impaired Energy Supply; Deficiency HDL Low Immune Deficiency Immune System Diseases Immunologic Deficiency Syndromes Joint Diseases Joint Instability Lung Function Decreased Musculoskeletal Diseases Quality of Life Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Stress

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Accelagen, Inc.

San Diego, California, 92121, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stem Cell 100+

Dietary Supplement

Open-Label 10-Component Dietary Supplement

Other names: SC100+

Primary outcomes

  1. Blood Pressure

    Time frame: Baseline and at an average of 15 weeks

    Change in Systolic and Diastolic Blood Pressure

  2. HDL Cholesterol

    Time frame: Baseline and at an average of 15 weeks

    Change in HDL Cholesterol

  3. Lung Capacity

    Time frame: Baseline and at an average of 15 weeks

    Change in Peak Expiatory Flow

  4. Stress Level

    Time frame: Baseline and at an average of 15 weeks

    Change in Heart Rate Variability

  5. Heart Rate

    Time frame: Baseline and at an average of 15 weeks

    Change in Heart Rate

Secondary outcomes

  1. 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)

  2. 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)

  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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

Sponsors and collaborators

Lead sponsor

Centagen, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 14, 2017
Registry last updated
Feb 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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