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

Not Applicable

Terminated

• Conditions: Human Microbiome
• Interventions: Dietary Supplement: Synbiotic; Dietary Supplement: Probiotic; Dietary Supplement: Placebo

• Registration Number: NCT03907501
• Lead Sponsor: University of California, San Diego

Brief 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.

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-04-03
• Study First Submitted QC: 2019-04-04
• Study First Posted: 2019-04-09
• Primary Completion: 2021-05-05
• Study Completion: 2021-07-12
• Results First Submitted: 2021-12-29
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-05
• Last Update Submitted: 2023-07-05
• Results First Posted: 2023-07-06
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Synbiotic	Synbiotic	Two grams of organic Triphala powder (Banyan Botanicals, Inc.) with 1 capsule VSL#3® (VSL Pharmaceuticals, Inc.) probiotic taken with a few ounces of room temperature water in the morning and at bedtime for 8 weeks. Subjects will be provided both written and verbal instructions and given a kit containing encapsulated Organic Triphala powder (Banyan Botanicals, Inc.) and VSL#3® (VSL Pharmaceuticals, Inc.) capsules.
Probiotic	Probiotic	Subjects will be provided both written and verbal instructions and given a kit containing encapsulated Organic Triphala powder (Banyan Botanicals, Inc.). Subjects will take 2 grams of organic Triphala powder with a few ounces of room temperature water in the morning and at bedtime.
Placebo	Placebo	Subjects will be provided both written and verbal instructions and given a kit containing placebo capsules. Subjects will be instructed to take 2 (inert) capsules with room temperature water in the morning and at bedtime.

Primary Outcome Measures

Name	Time	Method
Objective Measures of Gut Microbiome Health	8 weeks	16S rDNA sequencing of stool sample

Secondary Outcome Measures

Name	Time	Method
Inflammatory Biomarkers	8 weeks	Measure concentrations of 30 cytokines in blood samples with standard ELISA panel

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 La Jolla, California, United States