Human Microbiome
Conditions
Keywords
Gastrointestinal System, Inflammatory Biomarkers, Psychological Health
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.
Interventions
DIETARY_SUPPLEMENTSynbiotic
an herbal prebiotic plus probiotic
DIETARY_SUPPLEMENTProbiotic
Triphala alone
DIETARY_SUPPLEMENTPlacebo
Inert capsule
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Measures of Gut Microbiome Health | 8 weeks | 16S rDNA sequencing of stool sample |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Biomarkers | 8 weeks | Measure concentrations of 30 cytokines in blood samples with standard ELISA panel |
Countries
United States
Participant flow
Recruitment details
Recruitment dates 07/01/2019 - 11/01/2019. The location is UCSD School of Medicine Building 4 via IRB approved phone script. 34 subjects were approved for enrollment for our first wave of intervention/subjects and 18 began the study before the study was closed.
Pre-assignment details
18 subjects began the intervention (2 dropped out) before the study was closed. Few subjects were able to begin the intervention compared to what was planned before the study was closed due to multiple pandemic related impacts. As the budget was impacted, no data was generated. No data is reported as the samples will not be processed and no data was generated.
Participants by arm
| Arm | Count |
|---|---|
| Synbiotic 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.
Synbiotic: an herbal prebiotic plus probiotic | 7 |
| Triphala Triphala Group. Subjects will be provided both written and verbal instructions and given a kit containing Triphala capsules (Banyan Botanicals). Subjects will take 4 capsules (2g) of Triphala with room temperature water in the morning and at bedtime.
Triphala: encapsulated | 6 |
| Placebo 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.
Placebo: Inert capsule | 5 |
| Total | 18 |
Baseline characteristics
| Characteristic | Triphala | Placebo | Synbiotic | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 5 Participants | 6 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Age, Continuous | 74.5 years STANDARD_DEVIATION 8.4 | 73.6 years STANDARD_DEVIATION 6.6 | 69.3 years STANDARD_DEVIATION 5 | 72.2 years STANDARD_DEVIATION 6.7 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment United States | 6 participants | 5 participants | 7 participants | 18 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 6 | 0 / 5 |
| other Total, other adverse events | 0 / 7 | 0 / 6 | 0 / 5 |
| serious Total, serious adverse events | 0 / 7 | 0 / 6 | 0 / 5 |
Outcome results
Primary
Objective Measures of Gut Microbiome Health
16S rDNA sequencing of stool sample
Time frame: 8 weeks
Population: Study closed due to COVID-19. No data was generated. No data was analyzed.
Secondary
Inflammatory Biomarkers
Measure concentrations of 30 cytokines in blood samples with standard ELISA panel
Time frame: 8 weeks
Population: No data was generated or analyzed. Study closed due to COVID-19 impacts.