- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT03052491
Effects of a 10 Component Dietary Supplement on Health and the Quality of Life
Effects of a Multi-Pathway Dietary Supplement (Stem Cell 100+) on Indices of Health and Life Expectancy
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
California
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San Diego, California, Yhdysvallat, 92121
- Accelagen, Inc.
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: Stem Cell 100+ Intervention
Subjects take one 650 mg capsule by mouth twice daily for an average of 15 weeks
|
Open-Label 10-Component Dietary Supplement
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Blood Pressure
Aikaikkuna: Baseline and at an average of 15 weeks
|
Change in Systolic and Diastolic Blood Pressure
|
Baseline and at an average of 15 weeks
|
HDL Cholesterol
Aikaikkuna: Baseline and at an average of 15 weeks
|
Change in HDL Cholesterol
|
Baseline and at an average of 15 weeks
|
Lung Capacity
Aikaikkuna: Baseline and at an average of 15 weeks
|
Change in Peak Expiatory Flow
|
Baseline and at an average of 15 weeks
|
Stress Level
Aikaikkuna: Baseline and at an average of 15 weeks
|
Change in Heart Rate Variability
|
Baseline and at an average of 15 weeks
|
Heart Rate
Aikaikkuna: Baseline and at an average of 15 weeks
|
Change in Heart Rate
|
Baseline and at an average of 15 weeks
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Overall Health
Aikaikkuna: 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)
|
From baseline through study completion, an average of 15 weeks
|
Ability to Concentrate or Focus
Aikaikkuna: 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)
|
From baseline through study completion, an average of 15 weeks
|
Joint Flexibility
Aikaikkuna: 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)
|
From baseline through study completion, an average of 15 weeks
|
Work Productivity
Aikaikkuna: 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)
|
From baseline through study completion, an average of 15 weeks
|
Ability to Relax
Aikaikkuna: 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)
|
From baseline through study completion, an average of 15 weeks
|
Cold/Flu Resistance
Aikaikkuna: 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)
|
From baseline through study completion, an average of 15 weeks
|
Stress Tolerance
Aikaikkuna: 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)
|
From baseline through study completion, an average of 15 weeks
|
Energy Level
Aikaikkuna: 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)
|
From baseline through study completion, an average of 15 weeks
|
Endurance
Aikaikkuna: 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)
|
From baseline through study completion, an average of 15 weeks
|
Ease of Walking
Aikaikkuna: 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)
|
From baseline through study completion, an average of 15 weeks
|
Climbing Stairs
Aikaikkuna: 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)
|
From baseline through study completion, an average of 15 weeks
|
Overall Mood
Aikaikkuna: 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)
|
From baseline through study completion, an average of 15 weeks
|
Vitality
Aikaikkuna: 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)
|
From baseline through study completion, an average of 15 weeks
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Bryant Villeponteau, Ph.D., Centagen, Inc.
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
- 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.
- 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.
- 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.
- 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.
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
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