Clinical trial NCT03418857: Probiotics and Gut Health
Official title: The Role of Probiotics in Attenuating Inflammation and Improving Gut Health in Obese Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Metabolic Syndrome
Keywords: probiotics
Human
obesity
non-pharmacologic therapy
gut health
microbiome
inflammation
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
First posted: 2018-02-01
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change from baseline in inflammatory markers
timeFrame: 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:
measure: Change in number and activation of leukocytes
timeFrame: 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)
measure: Change in gut permeability
timeFrame: 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)
measure: Change in gut microbiota populations
timeFrame: 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)
measure: Change in metabolism of gut microbiota populations
timeFrame: 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:
measure: Change in trimethylamine N-oxide (TMAO) in serum
timeFrame: 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)
measure: Change in serum metabolomic profile
timeFrame: 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)
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
Study officials:
References:
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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.
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.
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.
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.
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.