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Probiotic Supplement and Microbiome, Immune System and Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03201068
Recruitment Status : Completed
First Posted : June 28, 2017
Last Update Posted : September 30, 2019
Sponsor:
Collaborator:
The Clorox Company
Information provided by (Responsible Party):
Justin L. Sonnenburg, Stanford University

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Microbiome Immune Function Inflammation Dietary Supplement: Probiotic supplement Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of a Probiotic Supplement on the Microbiome, Immune System, and Metabolic Syndrome
Actual Study Start Date : September 14, 2017
Actual Primary Completion Date : November 16, 2018
Actual Study Completion Date : December 4, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Probiotic supplement
Renew Life Formulas, Inc
Dietary Supplement: Probiotic supplement
Probiotic supplement capsule
Other Name: Renew Life Formulas, Inc

Placebo Comparator: Placebo
Placebo capsule
Dietary Supplement: Placebo
Placebo capsule




Primary Outcome Measures :
  1. Metabolic syndrome parameters: Waist Circumference, Blood pressure, Triglycerides, HDL-cholesterol, and Fasting Glucose. [ Time Frame: Baseline (week 4) and end of intervention (week 14) ]
    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).


Secondary Outcome Measures :
  1. Microbiota composition [ Time Frame: Baseline (week 4) and end of intervention (week 14) ]
    10-week change from baseline (week 4) in 16S rRNA enumeration at 14 weeks (end of intervention), determined using Illumina-based sequencing.

  2. Microbiota metabolites [ Time Frame: Baseline (week 4) and end of intervention (week 14) ]
    10-week change from Baseline (week 4) in short-chain fatty acids (SCFA) at 14 weeks (end of intervention).

  3. Cytokines [ Time Frame: Baseline (week 4) and end of intervention (week 14) ]
    10-week change from Baseline (week 4) in cytokines at 14 weeks (end of intervention).

  4. Chemokines [ Time Frame: Baseline (week 4) and end of intervention (week 14) ]
    10-week change from Baseline (week 4) in chemokines at 14 weeks (end of intervention).

  5. hs-C Reactive Protein (CRP) [ Time Frame: Baseline (week 4) and end of intervention (week 14) ]
    10-week change from Baseline (week 4) in hs-CRP at 14 weeks (end of intervention).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201068


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
The Clorox Company
Investigators
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Principal Investigator: Christopher D Gardner, PhD Stanford University
Additional Information:
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Responsible Party: Justin L. Sonnenburg, Associate Professor of Microbiology and Immunology, Stanford University
ClinicalTrials.gov Identifier: NCT03201068    
Other Study ID Numbers: 41697
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Inflammation
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases