Probiotics and Gut Health

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Change from baseline in inflammatory markers [Срок оценки: 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)]

Вторичные конечные точки (4)

• Change in number and activation of leukocytes [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The Pennsylvania State University — University Park

Публикации

• 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

Идентификаторы

NCT: NCT03418857 · STUDY0006843

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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