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NCT Number: NCT03418857

Probiotics and Gut Health

This study evaluates the effects of probiotic consumption on inflammatory outcomes and measures of gut health. Participants will be given yogurt with probiotics for one period and yogurt without probiotics for another, with a break in between. These periods will occur in random order.

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Key information

Conditions

Metabolic Syndrome Body Weight Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location status: Recruiting

Location contact

Connie J Rogers

CONTACT

[email protected]

Connie J Rogers, PhD, MPH

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI ≥ to 25 and less than 35 kg/m^2
  • Increased waist circumference (men: ≥ 94 cm, women: ≥ 80 cm)
  • At least one of the metabolic syndrome criteria-
  • serum triglycerides: ≥ 150 mg/dL
  • HDL cholesterol: ≤ 40 mg/dL in men, ≤ 50 mg/dL in women
  • blood pressure: ≥ 130 mmHg systolic or ≥ 85 mmHg diastolic
  • fasting plasma glucose ≥ 100 mg/dL

Exclusion criteria

  • allergy to dairy
  • smoking and/or use of tobacco products
  • systolic blood pressure ≥ 160 mmHg
  • diastolic blood pressure > 100 mmHg
  • fasting glucose ≥ 126 mg/dL
  • history of myocardial infarction, cardiovascular disease (CVD), stroke, diabetes mellitus, liver disease, kidney disease, thyroid disease (unless controlled on medication)
  • use of cholesterol or lipid lowering medications
  • use of anti-hypertensive or glucose lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, phytoestrogens, and stanol/sterol supplemented foods)
  • refusal to discontinue nutritional supplements, herbs, vitamins, or other probiotics
  • clinical diagnosis of inflammatory bowel disease (IBD) e.g. Chron's disease or ulcerative colitis
  • Use of antibiotics within the last 2 months
  • excessive alcohol consumption (≥ 14 standard drinks per week)
  • regular use of anti-inflammatory medications (e.g. aspirin, ibuprofen)

Treatment and study plan

Yogurt smoothie with BB-12

Drug

During the one month intervention period, the participants will consume one yogurt smoothie with BB-12 daily.

Yogurt smoothie

Drug

During the one month control period, the participants will consume one yogurt smoothie daily.

Primary outcomes

  1. Change from baseline in inflammatory markers

    Time frame: At baseline before intervention period 1, at endpoint of intervention period 1 (week 4), at baseline before intervention period 2 (week 8), at endpoint after intervention period 2 (week 12)

    Change in inflammatory markers in the serum and secreted cytokines from lipopolysaccharide (LPS)-stimulated peripheral blood mononuclear cells compared to baseline. In the serum the markers to be investigated are high sensitivity c-reactive protein (hs-CRP), tumor necrosis factor alpha (TNF-a), interleukin 1 beta (IL-1B), IL-6, IL-8, IL-10, IL-12p70, monocyte chemotactic protein 1 (MCP-1), macrophage inflammatory protein alpha (MIP-1a), sCD14, and LPS binding protein (LPB). From LPS-stimulated peripheral blood mononuclear cells the cytokines to be investigated are TNF-a, IL-1B, IL-6, IL-8, IL-10, IL-12p70, MCP-1, and MIP-1a. Changes in these inflammatory markers will assist in understanding how the consumption of yogurt containing BB-12 affects the inflammatory status of obese individuals.

Secondary outcomes

  1. Change in number and activation of leukocytes

    Time frame: At baseline before intervention period 1, at endpoint of intervention period 1 (week 4), at baseline before intervention period 2 (week 8), at endpoint after intervention period 2 (week 12)

    Change in quantity and activation of T cells, B cells, dendritic cells, natural killer cells, and monocytes measured by flow cytometry before and after each period. Changes in the number and activation of leukocytes will assist in understanding the impacts of the consumption of yogurt containing BB-12 on leukocytes in obese individuals.

  2. Change in gut permeability

    Time frame: At baseline before intervention period 1, at endpoint of intervention period 1 (week 4), at baseline before intervention period 2 (week 8), at endpoint after intervention period 2 (week 12)

    Change in gut permeability, assessed using a lactulose/mannitol gut permeability assay, from baseline. Changes in gut permeability will assist in understanding the impacts of the consumption of yogurt containing BB-12 on gut health and permeability in obese individuals.

  3. Change in gut microbiota populations

    Time frame: At baseline before intervention period 1, at endpoint of intervention period 1 (week 4), at baseline before intervention period 2 (week 8), at endpoint after intervention period 2 (week 12)

    Change in gut microbiota populations, assessed with 16s ribosomal ribonucleic acid (rRNA), compared to baseline. Changes in microbial populations will assist in understanding the impacts of the consumption of yogurt containing BB-12 on commensal gut microbiota in obese individuals.

  4. Change in metabolism of gut microbiota populations

    Time frame: At baseline before intervention period 1, at endpoint of intervention period 1 (week 4), at baseline before intervention period 2 (week 8), at endpoint after intervention period 2 (week 12)

    Change in the metabolism of gut microbiota populations, measured via transcriptomics, compared to baseline. Changes in the transcriptome of the commensal microbiota will assist in understanding the impacts of the consumption of yogurt containing BB-12 on the metabolism of commensal gut microbiota in obese individuals.

Other outcomes

  1. Change in trimethylamine N-oxide (TMAO) in serum

    Time frame: At baseline before intervention period 1, at endpoint of intervention period 1 (week 4), at baseline before intervention period 2 (week 8), at endpoint after intervention period 2 (week 12)

    Change in TMAO in serum measured using liquid chromatography with tandem mass spectrometry (LC-MS) compared to baseline. Changes in TMAO, which is associated with gut microbiota, will assist in understanding the mechanism that connects changes in the commensal microbiota in the gut to inflammatory outcomes in obese individuals.

  2. Change in serum metabolomic profile

    Time frame: At baseline before intervention period 1, at endpoint of intervention period 1 (week 4), at baseline before intervention period 2 (week 8), at endpoint after intervention period 2 (week 12)

    Change in serum metabolomic profile, assessed in hydrophilic and hydrophobic fractions, compared to baseline. Changes in the metabolomic profile will assist in understanding the underlying mechanisms that connect consumption of yogurt containing BB-12 to changes in inflammatory status in obese individuals.

Study contacts

Contact information is provided by the study sponsor or research team.

Connie J Rogers, PhD, MPH

CONTACT

[email protected]

814 867 3716

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • United States Department of Agriculture (USDA)

Registry information

Official study title

The Role of Probiotics in Attenuating Inflammation and Improving Gut Health in Obese Adults

Acronym: PRO

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 1, 2018
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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