NCT03052491

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 14, 2017

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

February 8, 2017

Last Update Submit

February 9, 2017

Conditions

Blood PressureHDL LowStressLung Function DecreasedQuality of LifeEnergy Supply; DeficiencyConcentration Ability ImpairedJoint InstabilityImmune Deficiency

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (13)

  • Overall Health

    From baseline through study completion, an average of 15 weeks

  • Ability to Concentrate or Focus

    From baseline through study completion, an average of 15 weeks

  • Joint Flexibility

    From baseline through study completion, an average of 15 weeks

  • Work Productivity

    From baseline through study completion, an average of 15 weeks

  • Ability to Relax

    From baseline through study completion, an average of 15 weeks

  • +8 more secondary outcomes

Study Arms (1)

Stem Cell 100+ Intervention

EXPERIMENTAL

Subjects take one 650 mg capsule by mouth twice daily for an average of 15 weeks

Dietary Supplement: Stem Cell 100+

Interventions

Stem Cell 100+DIETARY_SUPPLEMENT

Open-Label 10-Component Dietary Supplement

Also known as: SC100+
Stem Cell 100+ Intervention

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Accelagen, Inc.

San Diego, California, 92121, United States

Location

Related Publications (5)

  • 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.

    PMID: 25879540BACKGROUND

  • 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.

    PMID: 11113618BACKGROUND

  • 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.

    PMID: 9315443BACKGROUND

  • 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.

    PMID: 9343401BACKGROUND

  • 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.

    PMID: 7613096BACKGROUND

Related Links

MeSH Terms

Conditions

Respiratory InsufficiencyJoint InstabilityImmunologic Deficiency Syndromes

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesJoint DiseasesMusculoskeletal DiseasesImmune System Diseases

Study Officials

  • Bryant Villeponteau, Ph.D.

    Centagen, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Open-label field trial without a placebo.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2017

First Posted

February 14, 2017

Study Start

March 12, 2016

Primary Completion

August 24, 2016

Study Completion

August 24, 2016

Last Updated

February 14, 2017

Record last verified: 2017-02

Locations

US(1)