Effects of Triphala and VSL#3 Probiotic Supplementation on Stool Microbiome Profiles and Inflammation (TRIPH2017)

University of California San Diego

Status: Terminated

Conditions: Human Microbiome

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Placebo; Dietary Supplement: Synbiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT03907501

TRIPH2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 3 patient groups, including a placebo group

Synbiotic

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Synbiotic

Probiotic

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Probiotic

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo