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Blood PressureNCT03052491

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

A study testing Stem Cell 100+ in people with Blood Pressure and HDL Low, run by Centagen, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 35 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Blood Pressure, HDL Low, Stress
What is being tested?
Stem Cell 100+
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
12 Mar 2016to 24 Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Accelagen, Inc.

    San Diego, California, 92121

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Stem Cell 100+
Medical subject headings
Respiratory Insufficiency, Joint Instability, Immunologic Deficiency Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stem Cell 100+Dietary supplement

    Also called SC100+

    Open-Label 10-Component Dietary Supplement

Study groups in NCT03052491
Study groupRoleWhat they receive
Stem Cell 100+ InterventionExperimentalSubjects take one 650 mg capsule by mouth twice daily for an average of 15 weeks
Receives: Dietary Supplement: Stem Cell 100+

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood Pressure

    Change in Systolic and Diastolic Blood Pressure

    Measured: Baseline and at an average of 15 weeks

  2. HDL Cholesterol

    Change in HDL Cholesterol

    Measured: Baseline and at an average of 15 weeks

  3. Lung Capacity

    Change in Peak Expiatory Flow

    Measured: Baseline and at an average of 15 weeks

  4. Stress Level

    Change in Heart Rate Variability

    Measured: Baseline and at an average of 15 weeks

  5. Heart Rate

    Change in Heart Rate

    Measured: Baseline and at an average of 15 weeks

Secondary outcomes (13)

  1. Overall Health

    Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)

    Measured: From baseline through study completion, an average of 15 weeks

  2. Ability to Concentrate or Focus

    Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)

    Measured: From baseline through study completion, an average of 15 weeks

  3. Joint Flexibility

    Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)

    Measured: From baseline through study completion, an average of 15 weeks

  4. Work Productivity

    Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)

    Measured: From baseline through study completion, an average of 15 weeks

  5. Ability to Relax

    Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)

    Measured: From baseline through study completion, an average of 15 weeks

  6. Cold/Flu Resistance

    Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)

    Measured: From baseline through study completion, an average of 15 weeks

  7. Stress Tolerance

    Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)

    Measured: From baseline through study completion, an average of 15 weeks

  8. Energy Level

    Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)

    Measured: From baseline through study completion, an average of 15 weeks

  9. Endurance

    Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)

    Measured: From baseline through study completion, an average of 15 weeks

  10. Ease of Walking

    Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)

    Measured: From baseline through study completion, an average of 15 weeks

  11. Climbing Stairs

    Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)

    Measured: From baseline through study completion, an average of 15 weeks

  12. Overall Mood

    Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)

    Measured: From baseline through study completion, an average of 15 weeks

  13. Vitality

    Self-Reported Change based on a 7 point range from Much Better (+3) to Much Worse (-3)

    Measured: From baseline through study completion, an average of 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2017
  2. Study start12 Mar 2016
  3. Primary completion24 Aug 2016
  4. Study completion24 Aug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Open-label field trial without a placebo.
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03052491
Sponsor's protocol ID
SC100+ Clinical #1
Status last verified
Feb 2017
First submitted
8 Feb 2017
Last updated
14 Feb 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Villeponteau B, Matsagas K, Nobles AC, Rizza C, Horwitz M, Benford G, Mockett RJ. Herbal supplement extends life span under some environmental conditions and boosts stress resistance. PLoS One. 2015 Apr 16;10(4):e0119068. doi: 10.1371/journal.pone.0119068. eCollection 2015.

    PubMed 25879540

  • Villeponteau B, Cockrell R, Feng J. Nutraceutical interventions may delay aging and the age-related diseases. Exp Gerontol. 2000 Dec;35(9-10):1405-17. doi: 10.1016/s0531-5565(00)00182-0.

    PubMed 11113618

  • Villeponteau B. The heterochromatin loss model of aging. Exp Gerontol. 1997 Jul-Oct;32(4-5):383-94. doi: 10.1016/s0531-5565(96)00155-6.

    PubMed 9315443

  • Marusic L, Anton M, Tidy A, Wang P, Villeponteau B, Bacchetti S. Reprogramming of telomerase by expression of mutant telomerase RNA template in human cells leads to altered telomeres that correlate with reduced cell viability. Mol Cell Biol. 1997 Nov;17(11):6394-401. doi: 10.1128/MCB.17.11.6394.

    PubMed 9343401

  • Harley CB, Villeponteau B. Telomeres and telomerase in aging and cancer. Curr Opin Genet Dev. 1995 Apr;5(2):249-55. doi: 10.1016/0959-437x(95)80016-6.

    PubMed 7613096

Questions about this trial

What is this clinical trial studying?

A study testing Stem Cell 100+ in people with Blood Pressure and HDL Low, run by Centagen, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Pressure (time frame: Baseline and at an average of 15 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03052491, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2017.

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