The Role of Probiotics in Attenuating Inflammation and Improving Gut Health in Obese Adults
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline in inflammatory markers
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Yogurt smoothie with BB-12 (Drug)
Control
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.
干预措施: Yogurt smoothie (Drug)
结局指标
主要结局
Change from baseline in inflammatory markers
时间窗: 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 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.
次要结局
- 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 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))
- 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))
研究者
Connie J Rogers
Associate Professor of Nutritional Sciences
Penn State University