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

Study Overview
=================
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.

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

Conditions
-----------------
Human Microbiome

Intervention / Treatment
-----------------
* Dietary Supplement: Synbiotic
* Dietary Supplement: Probiotic
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Cognitively intact; Able to give informed consent in English; Medical clearance by their doctor; > 60 years of age. Exclusion criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synbiotic<br>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<br>* an herbal prebiotic plus probiotic<br>|
| Active Comparator: Probiotic<br>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<br>* Triphala alone<br>|
| Placebo Comparator: Placebo<br>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<br>* Inert capsule<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Measures of Gut Microbiome Health | 16S rDNA sequencing of stool sample | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory Biomarkers | Measure concentrations of 30 cytokines in blood samples with standard ELISA panel | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastrointestinal System, Inflammatory Biomarkers, Psychological Health