Back to resultsProbiotics and Gut Health (PRO)
Primary Purpose
Metabolic Syndrome
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Yogurt smoothie with BB-12
Yogurt smoothie
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring probiotics, Human, obesity, non-pharmacologic therapy, gut health, microbiome, inflammation
Eligibility 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)
Sites / Locations
- The Pennsylvania State UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change from baseline in inflammatory markers
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
Change in number and activation of leukocytes
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
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
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
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.
Full Information
NCT ID
NCT03418857
First Posted
December 13, 2017
Last Updated
December 12, 2021
Sponsor
Penn State University
Collaborators
United States Department of Agriculture (USDA)
1. Study Identification
Unique Protocol Identification Number
NCT03418857
Brief Title
Probiotics and Gut Health
Acronym
PRO
Official Title
The Role of Probiotics in Attenuating Inflammation and Improving Gut Health in Obese Adults
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2018 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
Collaborators
United States Department of Agriculture (USDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
probiotics, Human, obesity, non-pharmacologic therapy, gut health, microbiome, inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Yogurt smoothie with BB-12
Intervention Description
During the one month intervention period, the participants will consume one yogurt smoothie with BB-12 daily.
Intervention Type
Drug
Intervention Name(s)
Yogurt smoothie
Intervention Description
During the one month control period, the participants will consume one yogurt smoothie daily.
Primary Outcome Measure Information:
Title
Change from baseline in inflammatory markers
Description
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.
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)
Secondary Outcome Measure Information:
Title
Change in number and activation of leukocytes
Description
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.
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)
Title
Change in gut permeability
Description
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.
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)
Title
Change in gut microbiota populations
Description
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.
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)
Title
Change in metabolism of gut microbiota populations
Description
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.
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)
Other Pre-specified Outcome Measures:
Title
Change in trimethylamine N-oxide (TMAO) in serum
Description
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.
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)
Title
Change in serum metabolomic profile
Description
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.
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Connie J Rogers, PhD, MPH
Phone
814 867 3716
Email
cjr102@psu.edu
Facility Information:
Facility Name
The Pennsylvania State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Connie J Rogers
Email
cjr102@psu.edu
First Name & Middle Initial & Last Name & Degree
Connie J Rogers, PhD, MPH
12. IPD Sharing Statement
Citations:
PubMed Identifier
26621631
Citation
Meng H, Ba Z, Lee Y, Peng J, Lin J, Fleming JA, Furumoto EJ, Roberts RF, Kris-Etherton PM, Rogers CJ. Consumption of Bifidobacterium animalis subsp. lactis BB-12 in yogurt reduced expression of TLR-2 on peripheral blood-derived monocytes and pro-inflammatory cytokine secretion in young adults. Eur J Nutr. 2017 Mar;56(2):649-661. doi: 10.1007/s00394-015-1109-5. Epub 2015 Nov 30.
Results Reference
background
PubMed Identifier
20420526
Citation
Aggarwal BB. Targeting inflammation-induced obesity and metabolic diseases by curcumin and other nutraceuticals. Annu Rev Nutr. 2010 Aug 21;30:173-99. doi: 10.1146/annurev.nutr.012809.104755.
Results Reference
background
PubMed Identifier
22872030
Citation
Leber B, Tripolt NJ, Blattl D, Eder M, Wascher TC, Pieber TR, Stauber R, Sourij H, Oettl K, Stadlbauer V. The influence of probiotic supplementation on gut permeability in patients with metabolic syndrome: an open label, randomized pilot study. Eur J Clin Nutr. 2012 Oct;66(10):1110-5. doi: 10.1038/ejcn.2012.103. Epub 2012 Aug 8.
Results Reference
background
PubMed Identifier
18305141
Citation
Cani PD, Bibiloni R, Knauf C, Waget A, Neyrinck AM, Delzenne NM, Burcelin R. Changes in gut microbiota control metabolic endotoxemia-induced inflammation in high-fat diet-induced obesity and diabetes in mice. Diabetes. 2008 Jun;57(6):1470-81. doi: 10.2337/db07-1403. Epub 2008 Feb 27.
Results Reference
background
PubMed Identifier
26315217
Citation
Sugahara H, Odamaki T, Fukuda S, Kato T, Xiao JZ, Abe F, Kikuchi J, Ohno H. Probiotic Bifidobacterium longum alters gut luminal metabolism through modification of the gut microbial community. Sci Rep. 2015 Aug 28;5:13548. doi: 10.1038/srep13548.
Results Reference
background
PubMed Identifier
21899798
Citation
Rizzardini G, Eskesen D, Calder PC, Capetti A, Jespersen L, Clerici M. Evaluation of the immune benefits of two probiotic strains Bifidobacterium animalis ssp. lactis, BB-12(R) and Lactobacillus paracasei ssp. paracasei, L. casei 431(R) in an influenza vaccination model: a randomised, double-blind, placebo-controlled study. Br J Nutr. 2012 Mar;107(6):876-84. doi: 10.1017/S000711451100420X. Epub 2011 Sep 7.
Results Reference
background
Learn more about this trial
Probiotics and Gut Health
We'll reach out to this number within 24 hrs