Clinical trial NCT03907501: Effects of Triphala and VSL#3 Probiotic Supplementation on Stool Microbiome Profiles and Inflammation
Official title: The Effects of Organic Triphala and VSL#3 Probiotic Supplementation on Stool Microbiome Profiles and Inflammation in Healthy Elderly Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Human Microbiome
Keywords: Gastrointestinal System
Inflammatory Biomarkers
Psychological Health
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 75
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion criteria:

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

Exclusion criteria:

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

Primary outcomes:
measure: Objective Measures of Gut Microbiome Health
timeFrame: 8 weeks
Secondary outcomes:
measure: Inflammatory Biomarkers
timeFrame: 8 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Christine T Peterson, PhD
role: PRINCIPAL_INVESTIGATOR
References: