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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 : November 7, 2018
Sponsor:
Collaborator:
United States Department of Agriculture (USDA)
Information provided by (Responsible Party):
Connie J Rogers, Penn State University

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Drug: Yogurt smoothie with BB-12 Drug: Yogurt smoothie Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Role of Probiotics in Attenuating Inflammation and Improving Gut Health in Obese Adults
Actual Study Start Date : June 29, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
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.
Drug: Yogurt smoothie with BB-12
During the one month intervention period, the participants will consume one yogurt smoothie with BB-12 daily.

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT03418857


Contacts
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Contact: Connie J Rogers, PhD, MPH 814 867 3716 cjr102@psu.edu

Locations
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United States, Pennsylvania
The Pennsylvania State University Recruiting
University Park, Pennsylvania, United States, 16802
Contact: Connie J Rogers       cjr102@psu.edu   
Principal Investigator: Connie J Rogers, PhD, MPH         
Sponsors and Collaborators
Penn State University
United States Department of Agriculture (USDA)

Publications:

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Responsible Party: Connie J Rogers, Associate Professor of Nutritional Sciences, Penn State University
ClinicalTrials.gov Identifier: NCT03418857     History of Changes
Other Study ID Numbers: STUDY0006843
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Connie J Rogers, Penn State University:
probiotics
Human
obesity
non-pharmacologic therapy
gut health
microbiome
inflammation

Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases