Probiotics and Gut Health

NCT03418857 | Recruiting Phase 1 FDA Drug

• 1 other identifier: STUDY0006843
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

probiotics; Human; obesity; non-pharmacologic therapy; gut health; microbiome; inflammation

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (4)

• Change in number and activation of leukocytes

  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

  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

  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 metabolism of gut microbiota populations

  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 Outcomes (2)

• Change in trimethylamine N-oxide (TMAO) in serum

  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

  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)

Study Arms (2)

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

Control

PLACEBO COMPARATOR

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

Interventions

Yogurt smoothie with BB-12 DRUG

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

Experimental

Yogurt smoothie DRUG

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

Control

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Penn State University: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 26621631 BACKGROUND

• 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.

  PMID: 20420526 BACKGROUND

• 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.

  PMID: 22872030 BACKGROUND

• 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.

  PMID: 18305141 BACKGROUND

• 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.

  PMID: 26315217 BACKGROUND

• 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.

  PMID: 21899798 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Obesity; Inflammation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Connie J Rogers, PhD, MPH

CONTACT

814 867 3716; cjr102@psu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Nutritional Sciences

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: February 1, 2018
• Study Start: June 29, 2018
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 14, 2021

Record last verified: 2021-12

Locations

US (1)