NCT03907501

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

The Effects of Organic Triphala and VSL#3 Probiotic Supplementation on Stool Microbiome Profiles and Inflammation in Healthy Elderly Subjects

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Primary Aim: In healthy, cognitively intact elderly subjects, determine the effects of an 8-week synbiotic supplement intervention on the stool microbiome (pre- and post-intervention) as compared to Triphala alone and placebo. Secondary Aim: In healthy elderly subjects, examine the effects of an 8-week synbiotic supplementation intervention on inflammatory blood markers compared to herb alone or placebo. Exploratory Aim 1: In healthy elderly subjects, examine the effects of an 8-week synbiotic intervention on gastrointestinal and psychological health via questionnaires compared to herb alone or placebo.

Conditions

• Human Microbiome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Synbiotic	an herbal prebiotic plus probiotic
DIETARY_SUPPLEMENT	Probiotic	Triphala alone
DIETARY_SUPPLEMENT	Placebo	Inert capsule

Timeline

• Start date: 2019-02-01
• Primary completion: 2021-05-05
• Completion: 2021-07-12
• First posted: 2019-04-09
• Last updated: 2023-07-06
• Results posted: 2023-07-06

Locations

1 site across 1 country: United States