Effects of a 10 Component Dietary Supplement on Health and the Quality of Life
9 février 2017 mis à jour par: Centagen, Inc.
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
15
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
California
-
San Diego, California, États-Unis, 92121
- Accelagen, Inc.
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
35 ans à 80 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Blood Pressure
Délai: 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
Délai: Baseline and at an average of 15 weeks
|
Change in HDL Cholesterol
|
Baseline and at an average of 15 weeks
|
|
Lung Capacity
Délai: Baseline and at an average of 15 weeks
|
Change in Peak Expiatory Flow
|
Baseline and at an average of 15 weeks
|
|
Stress Level
Délai: Baseline and at an average of 15 weeks
|
Change in Heart Rate Variability
|
Baseline and at an average of 15 weeks
|
|
Heart Rate
Délai: Baseline and at an average of 15 weeks
|
Change in Heart Rate
|
Baseline and at an average of 15 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall Health
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Bryant Villeponteau, Ph.D., Centagen, Inc.
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
12 mars 2016
Achèvement primaire (Réel)
24 août 2016
Achèvement de l'étude (Réel)
24 août 2016
Dates d'inscription aux études
Première soumission
8 février 2017
Première soumission répondant aux critères de contrôle qualité
9 février 2017
Première publication (Réel)
14 février 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 février 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 février 2017
Dernière vérification
1 février 2017
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SC100+ Clinical #1
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .