Summary

for people ages 65 years and up (full criteria)
healthy people welcome
at La Jolla, California
study started
estimated completion
Christine T Peterson, PhD

Description

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.

Official Title

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

Details

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.

Keywords

Human Microbiome Gastrointestinal System Inflammatory Biomarkers Psychological Health Inflammation Synbiotic Probiotic

Eligibility

You can join if…

Open to people ages 65 years and up

  1. Cognitively intact;
  2. Able to give informed consent in English;
  3. Medical clearance by their doctor;
  4. > 60 years of age.

You CAN'T join if...

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

Location

  • University of California, San Diego
    La Jolla California 92093 United States

Lead Scientist

  • Christine T Peterson, PhD
    Postdoctoral Scholar, Family Medicine and Public Health. Authored (or co-authored) 20 research publications

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT03907501
Study Type
Interventional
Last Updated