Probiotic Supplement and Microbiome, Immune System and Metabolic Syndrome

NCT03201068 | Completed

• 1 other identifier: 41697
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome; Microbiome; Immune Function; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Microbiota composition

  Baseline (week 4) and end of intervention (week 14)

• Microbiota metabolites

  Baseline (week 4) and end of intervention (week 14)

• Cytokines

  Baseline (week 4) and end of intervention (week 14)

• Chemokines

  Baseline (week 4) and end of intervention (week 14)

• hs-C Reactive Protein (CRP)

  Baseline (week 4) and end of intervention (week 14)

Study Arms (2)

Probiotic supplement

EXPERIMENTAL

Renew Life Formulas, Inc

Dietary Supplement: Probiotic supplement

Placebo

PLACEBO COMPARATOR

Placebo capsule

Dietary Supplement: Placebo

Interventions

Probiotic supplement DIETARY_SUPPLEMENT

Probiotic supplement capsule

Also known as: Renew Life Formulas, Inc

Probiotic supplement

Placebo DIETARY_SUPPLEMENT

Placebo capsule

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Abdominal obesity, defined as a waist circumference in men ≥102 cm (40 in) and in women ≥88 cm (35 in)
• Serum triglycerides ≥150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides
• 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
• Blood pressure ≥130/85 mmHg or drug treatment for elevated blood pressure
• Fasting plasma glucose (FPG) ≥100 mg/dL (5.6 mmol/L) or drug treatment for elevated blood glucose
• International Diabetes Federation Guidelines:
• 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:
• Triglycerides ≥150 mg/dL (1.7 mmol/L) or treatment for elevated triglycerides
• 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
• Systolic blood pressure ≥130, diastolic blood pressure ≥85, or treatment for hypertension

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• The Clorox Company: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 36803658 BACKGROUND

Related Links

• Study description and summary of results

MeSH Terms

Conditions

Metabolic Syndrome; Inflammation

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher D Gardner, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Microbiology and Immunology

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: June 28, 2017
• Study Start: September 14, 2017
• Primary Completion: November 16, 2018
• Study Completion: December 4, 2018
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)