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

NCT03907501 | Terminated Results

• 1 other identifier: TRIPH2017
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Microbiome

Keywords

Gastrointestinal System; Inflammatory Biomarkers; Psychological Health

Outcome Measures

Primary Outcomes (1)

• Objective Measures of Gut Microbiome Health

  16S rDNA sequencing of stool sample

  8 weeks

Secondary Outcomes (1)

• Inflammatory Biomarkers

  8 weeks

Study Arms (3)

Synbiotic

EXPERIMENTAL

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.

Dietary Supplement: Synbiotic

Probiotic

ACTIVE COMPARATOR

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.

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Synbiotic DIETARY_SUPPLEMENT

an herbal prebiotic plus probiotic

Synbiotic

Probiotic DIETARY_SUPPLEMENT

Triphala alone

Probiotic

Placebo DIETARY_SUPPLEMENT

Inert capsule

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Cognitively intact;
• Able to give informed consent in English;
• Medical clearance by their doctor;
• \> 60 years of age.

You may not qualify if:

• Alzheimer's Disease or other neurodegenerative disease such as Parkinson's Disease;
• Current use or use in the past 3 months of antimicrobial or steroidal drugs;
• Medical conditions affecting immune status (e.g., rheumatoid arthritis, heart failure, hepatitis C, HIV);
• Individuals diagnosed with Diabetes Mellitus
• International travel in past 3 months.
• Previous known side effect or negative reaction to VSL#3 or Triphala

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Synbiotics; Probiotics

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

Study Closed early due to COVID-19 related impacts.

Results Point of Contact

• Title: Dr. Christine Tara Peterson
• Organization: UCSD School of Medicine

chpeterson@health.ucsd.edu

7033959377

Study Officials

• Christine T Peterson, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study will employ double-blind masking and only the project manager will be aware if the participant is assigned to take the synbiotic, triphala alone, or placebo. At the end of the 8 weeks, participants will be made aware of their randomly assigned supplement.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Project Scientist

Model Details: Interested and eligible participants will be randomly assigned to either an 8-week synbiotic group, herb alone, or placebo control with a goal to obtain 60 patients who complete the study (20 in each group) after an estimated 20% attrition. Placebo control subjects will be given the option of having the 8-weeks of herbal synbiotic for directed personal use upon conclusion of the study.

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 9, 2019
• Study Start: February 1, 2019
• Primary Completion: May 5, 2021
• Study Completion: July 12, 2021
• Last Updated: July 6, 2023
• Results First Posted: July 6, 2023

Record last verified: 2023-07

Locations

US (1)