Probiotic Supplement and Microbiome, Immune System and Metabolic Syndrome

Impact of a Probiotic Supplement on the Microbiome, Immune System, and Metabolic Syndrome

This study will define the impact of a probiotic supplement on microbiome, immune system, and metabolic syndrome. This study will determine the degree to which a probiotic supplement can 1) improve metabolic markers and metrics of metabolic syndrome, 2) alter microbiota composition and function, 3) impact microbiota metabolites, short-chain fatty acids-potential normalizers of metabolic and immune dysfunction, and 4) regulate immune status and function including reducing chronic, systemic inflammation as assessed by high dimensional immune profiling.

Study Overview

• Status: Completed
• Conditions: Inflammation; Metabolic Syndrome; Microbiome; Immune Function
• Intervention / Treatment: Dietary supplement: Probiotic supplement; Dietary supplement: Placebo

Detailed Description

The centrality of the gut microbiota to human health has emerged in just the last decade, with the last three years implicating our modern, deteriorated gut microbiota in numerous chronic diseases. It is likely dietary changes in the last half-century consistent with adoption of the Western diet have had an adverse impact on the gut microbiota. A critically important next step in this field of research is to identify how different probiotic supplements can potentially restore the microbiota in alignment with the optimization of human health, particularly in regard to the reversal or prevention of chronic diseases including obesity, metabolic syndrome, and inflammatory bowel disease. This study is designed to elicit and contrast the amount of increase in microbiota diversity and related metabolic output achievable following consumption of a probiotic supplement commonly available to the general population. The results could contribute to dietary recommendations for reversing the chronic disease epidemics of westernization.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 and older
• Must have metabolic syndrome as defined by having at least 2 of the 5 criteria per either ATP III guidelines OR International Diabetes Federation (IDF) guidelines:

ATP III guidelines:

1. Abdominal obesity, defined as a waist circumference in men ≥102 cm (40 in) and in women ≥88 cm (35 in)
2. Serum triglycerides ≥150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides
3. Serum high-density lipoprotein (HDL) cholesterol <40 mg/dL (1 mmol/L) in men and <50 mg/dL (1.3 mmol/L) in women or drug treatment for low HDL cholesterol
4. Blood pressure ≥130/85 mmHg or drug treatment for elevated blood pressure
5. Fasting plasma glucose (FPG) ≥100 mg/dL (5.6 mmol/L) or drug treatment for elevated blood glucose

International Diabetes Federation Guidelines:

1. Increased waist circumference, with ethnic-specific waist circumference cut-points:

   White and all other ethnic groups - Men ≥ 94 cm; Women ≥ 80 cm South Asians, Chinese, and Japanese - Men ≥ 90 cm; Women ≥ 80 cm

   PLUS any two of the following:

2. Triglycerides ≥150 mg/dL (1.7 mmol/L) or treatment for elevated triglycerides
3. HDL cholesterol <40 mg/dL (1.03 mmol/L) in men or <50 mg/dL (1.29 mmol/L) in women, or treatment for low HDL
4. Systolic blood pressure ≥130, diastolic blood pressure ≥85, or treatment for hypertension
5. FPG ≥100 mg/dL (5.6 mmol/L) or previously diagnosed type 2 diabetes; an oral glucose tolerance test is recommended for patients with an elevated fasting plasma glucose, but not required.

Exclusion Criteria:

• Body Mass Index (BMI) ≥ 40
• LDL >160 mg/dL.
• Vital signs outside of acceptable range at Screening Visit: blood pressure >159/99, oral temperature ≥ 100°F, pulse >100.
• Use of any of the following drugs within the last 6 months:systemic antibiotics (must be discontinued and avoided for 2 months prior to the study start), antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral); oral, intravenous, intramuscular, nasal or inhaled corticosteroids; cytokines; methotrexate or immunosuppressive cytotoxic agents;
• Use of large doses of commercial probiotics consumed within the last 6 months (greater than or equal to 108 cfu or organisms per day) - includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component (must be discontinued and avoided for one month prior to the study start). Ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo capsule	Dietary supplement: Placebo; Placebo capsule
Experimental: Probiotic supplement; Renew Life Formulas, Inc	Dietary supplement: Probiotic supplement; Probiotic supplement capsule; Other Names: Renew Life Formulas, Inc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic syndrome parameters: Waist Circumference, Blood pressure, Triglycerides, HDL-cholesterol, and Fasting Glucose.	10-week change from Baseline (week 4) in the number of subjects presenting 3 of the 5 parameters for metabolic syndrome (waist circumference, blood pressure, triglycerides, HDL-cholesterol, and fasting glucose) at 14 weeks (end of intervention).	Baseline (week 4) and end of intervention (week 14)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiota composition	10-week change from baseline (week 4) in 16S rRNA enumeration at 14 weeks (end of intervention), determined using Illumina-based sequencing.	Baseline (week 4) and end of intervention (week 14)
Microbiota metabolites	10-week change from Baseline (week 4) in short-chain fatty acids (SCFA) at 14 weeks (end of intervention).	Baseline (week 4) and end of intervention (week 14)
Cytokines	10-week change from Baseline (week 4) in cytokines at 14 weeks (end of intervention).	Baseline (week 4) and end of intervention (week 14)
Chemokines	10-week change from Baseline (week 4) in chemokines at 14 weeks (end of intervention).	Baseline (week 4) and end of intervention (week 14)
hs-C Reactive Protein (CRP)	10-week change from Baseline (week 4) in hs-CRP at 14 weeks (end of intervention).	Baseline (week 4) and end of intervention (week 14)

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: The Clorox Company
• Investigators: Principal Investigator: Christopher D Gardner, PhD, Stanford University

Publications and helpful links

General Publications

• Wastyk HC, Perelman D, Topf M, Fragiadakis GK, Robinson JL, Sonnenburg JL, Gardner CD, Sonnenburg ED. Randomized controlled trial demonstrates response to a probiotic intervention for metabolic syndrome that may correspond to diet. Gut Microbes. 2023 Jan-Dec;15(1):2178794. doi: 10.1080/19490976.2023.2178794.

Helpful Links

• Study description and summary of results

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2017
• Primary Completion (Actual): November 16, 2018
• Study Completion (Actual): December 4, 2018

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Inflammation; Metabolic Syndrome
• Other Study ID Numbers: 41697

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No