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Probiotics and Gut Health (PRO)

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ClinicalTrials.gov Identifier: NCT03418857
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
United States Department of Agriculture (USDA)
Information provided by (Responsible Party):
Connie J Rogers, Penn State University

Tracking Information
First Submitted Date  ICMJE December 13, 2017
First Posted Date  ICMJE February 1, 2018
Last Update Posted Date August 9, 2019
Actual Study Start Date  ICMJE June 29, 2018
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 31, 2018)
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Probiotics and Gut Health
Official Title  ICMJE The Role of Probiotics in Attenuating Inflammation and Improving Gut Health in Obese Adults
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE
  • Drug: Yogurt smoothie with BB-12
    During the one month intervention period, the participants will consume one yogurt smoothie with BB-12 daily.
  • Drug: Yogurt smoothie
    During the one month control period, the participants will consume one yogurt smoothie daily.
Study Arms  ICMJE
  • Experimental: Experimental
    Participants will consume one yogurt smoothie daily for the duration of the intervention that contains 3.16 × 109 colony forming units (CFU) bifidobacterium animalis subsp. lactis BB-12. Participants will be asked to refrain from consumption of other yogurt or probiotic-containing foods.
    Intervention: Drug: Yogurt smoothie with BB-12
  • Placebo Comparator: Control
    Participants will consume one yogurt smoothie daily for the duration of the intervention that contains no BB-12. Participants will be asked to refrain from consumption of other yogurt or probiotic-containing foods.
    Intervention: Drug: Yogurt smoothie
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Connie J Rogers, PhD, MPH 814 867 3716 cjr102@psu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03418857
Other Study ID Numbers  ICMJE STUDY0006843
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Connie J Rogers, Penn State University
Study Sponsor  ICMJE Penn State University
Collaborators  ICMJE United States Department of Agriculture (USDA)
Investigators  ICMJE Not Provided
PRS Account Penn State University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP