Effects of Triphala and VSL#3 Probiotic Supplementation on Stool Microbiome Profiles and Inflammation

NCT03907501 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-07-06

Study results available
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Summary

Normal aging can lead to loss of gut microbial biodiversity which is linked to inflammaging and immunosenescence or the loss of immunocompetence. Probiotics, such as VSL#3®, and certain herbal supplements such as Triphala are associated with restoration of gut community architecture, increased gut barrier function and decreased inflammation. The present project will examine the potential benefits of a synbiotic (which denotes a prebiotic plus probiotic, and in this study, is an herbal prebiotic plus probiotic) intervention (8 weeks of supplementation) on gut microbiome profiles assessed via stool, inflammatory blood markers, and questionnaires about gastrointestinal health and mood. In this exploratory study, the investigators will examine psychological and physical functioning at baseline and after 8 weeks of supplementation with synbiotic, Triphala alone, or placebo.

Conditions

  • Human Microbiome

Interventions

DIETARY_SUPPLEMENT

Synbiotic

an herbal prebiotic plus probiotic

DIETARY_SUPPLEMENT

Probiotic

Triphala alone

DIETARY_SUPPLEMENT

Placebo

Inert capsule

Sponsors & Collaborators

Principal Investigators

  • Christine T Peterson, PhD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2021-05-05
Completion
2021-07-12

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03907501 on ClinicalTrials.gov