Probiotics and Gut Health

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• 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)]

Secondary outcome measures (4)

• 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 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 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 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)]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• The Pennsylvania State University — University Park

Publications

• 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
• 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
• 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
• 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
• 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
• 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 20 PMID 21899798

Identifiers

NCT: NCT03418857 · STUDY0006843

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗