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临床试验/NCT04283448
NCT04283448已完成不适用

Gut Microbiota Dependent and Independent Impacts of Dietary Pulses on Pre- and Postprandial Metabolism and Inflammation in Overweight/Obese Humans

Montana State University2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2020年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
Change in Postprandial Serum Triglyceride

研究概览

简要总结

The overall goal of this investigation is to determine gut microbiome dependent and independent impacts of pulse consumption on metabolic resilience and metabolic risk profiles for type 2 diabetes (T2D) and cardiovascular disease (CVD) risk. Specifically, pulse crop consumption has unrealized potential to fundamentally alter how the body responds to disease promoting metabolic stresses of postprandial triglyceride and inflammation responses. The specific objectives are to (1) Determine the impact of green lentil consumption on postprandial triglyceride (TG) and inflammation responses to a high-fat meal challenge. (2) Determine the extent to which the gut microbiome and changes in the gut microbiome induced by pulse consumption influence health impacts (3) Measure metabolomic profiles to elucidate underlying mechanisms linking pulse consumption to improved health. To achieve these objectives investigators will determine the effects of green lentil on high impact risk factors of large postprandial triglyceride excursions and inflammation, composition of and changes in the gut microbiomes, and both gut and serum metabolomes in overweight/obese (OW/OB) individuals with elevated risk. The 12-week intervention will consist of consumption of 4.6 or 0 cups of pulses per week across 7 pre-made meals (matched for macronutrient content (except fiber) provided to experimental and control groups. The following hypotheses will be tested in the proposed investigation:

H1: Lentil consumption lower postprandial TG and inflammation responses and improve overall metabolic health.

H2: Characteristics of the gut microbiome and changes in the gut microbiome induced by lentil consumption substantially influence health impacts of pulse consumption.

H3: Features of the fecal and serum metabolomes distinguishing lentil and control treatments correspond to metabolic pathways elucidating potential gut microbiome dependent and independent mechanisms linking pulse consumption to improved health.

详细描述

Investigators will utilize a parallel intervention of lentil versus macronutrient-matched (not including fiber) control treatment for 12 weeks in OW/OB adults with demonstrated risk for T2D and CVD. Experimental diets will be provided to participants in the form of pre-made midday meals to exploit the second meal effect and lower caloric intake at the evening meal. Pre- and post-intervention assessments will be made for the following variables: makeup of the gut microbiome (microbial species and relative abundance), gut metabolome, postprandial response of TG, inflammatory cytokines, and serum metabolome to a high-fat meal challenge (established inflammation stimulus), fasting serum glucose, lipid, insulin, inflammation markers and metabolome, blood pressure, and anthropometric measures including weight, body composition, waist circumference, and quantity of visceral adipose tissue. Habitual diet will be measured so that these variables can be used to aid in our characterization of participants and aid in analysis and interpretation of data.

Procedures:

Postprandial lipidemic and inflammation responses: High-fat meal challenges with 40 to 100 g of dietary fat are an established laboratory test to measure both postprandial triglyceridemic and inflammation responses. Investigators have used a 50 g dose of fat delivered in the form of butter on toast on > 50 individuals because this particular dose is effective at discriminating between low versus high TG and inflammation responders. In brief, participants will report to the laboratory after an overnight fast, an indwelling venous catheter will be placed in an antecubital vein, and blood samples will be collected before, and 1, 2, 3, 4, and 5 hours following ingestion of the high-fat meal. Samples will be analyzed in real time for TG (and full lipid panel plus glucose) using a clinical chemistry analyzer (Piccolo xpress), while serum samples will be aliquoted and stored at -80 C until analysis for inflammatory cytokines, metabolomics, and insulin. Investigators will measure inflammatory cytokines (TNF-α, IFN-y, interleukin (IL)-1β, IL-6 IL-17, IL-23, IL-10, and granulocyte macrophage colony stimulating factor (GM-CSF)) using high-sensitivity Luminex multiplexing technology (Bio-Rad Bio-Plex® 200 HTS) prepared by Millipore.

Dietary intervention: Using methods established for an ongoing CRT with lentils, investigators will prepare 7 meals per participant per week to deliver a dose of 4.6 or 0 cups of lentils per week for the experimental and control groups. Meals are matched for macronutrient content (except for fiber), and ground turkey or chicken replaces lentils in the control meals. Dietary intervention will be 12 weeks in length with a possible extension to 13 weeks if participants either 1) miss 3 or more meals in a row at any point during the intervention or 2) miss any meals at all in the last week of the intervention prior to their final visit. To keep the meal intervention period between 12 and 13 weeks, participants will be dropped from the study if meal adherence failures result in more than a one week intervention extension.

Participants will be instructed to consume food provided for their midday meal, and then to proactively reduce portion sizes and to not eat beyond fullness at the evening meal. This strategy exploits the satiety effect of pulses at the midday meal and the 'second meal effect' in which volitional consumption is reduced at the next meal, the evening meal. Each participant will be surveyed once weekly to determine whether they consumed the experimental meal that day, their perceptions of hunger, fullness, satiety, and satisfaction with that day's meal (at 4:00 pm), and their gastrointestinal comfort (level of bloating, flatulence, cramping, and comfort) throughout the day (at 8:00 pm). This methodology has been successfully implemented in our ongoing study to demonstrate that lentil meals are equally pleasing, produce greater satiety, and are well-tolerated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Waist circumference > 35 inches for women and > 40 inches for men
  • Non-fasting serum triglyceride concentration > 175 mg/dl

排除标准

  • Allergy to wheat
  • Taking medication that will influence cholesterol, lipids, or inflammation
  • Pregnant or use of hormonal contraceptive method
  • Have diabetes, a pacemaker, or other health conditions that may interfere with the study outcomes
  • Planning to undergo a weight loss intervention or change in exercise regimen

结局指标

主要结局

Change in Postprandial Serum Triglyceride

时间窗: 12 weeks

Area under the curve for serum triglyceride concentration calculated from 0 - 5 hours post consumption of a meal containing 50 g of fat. Value reported as the change from baseline to 12 weeks post intervention (Value at 12 weeks minus value at baseline).

Change in Postprandial Serum Glucose

时间窗: 12 weeks

Area under the curve for serum glucose concentration calculated from 0 - 5 hours post consumption of a meal containing 50 g of fat. Value reported as the change from baseline to 12 weeks post intervention (Value at 12 weeks minus value at baseline)

Change in Postprandial Serum Inflammatory Cytokines

时间窗: 12 weeks

Area under the curve for inflammatory cytokine (tumor necrosis factor-alpha, interleukin-(IL)1beta, IL-6, IL-10, IL-17, IL-23, interferon-gamma, and granulocyte macrophage-colony stimulating factor) concentration calculated from 0 - 5 hours post consumption of a meal containing 50 g of fat. Value reported as the change in AUC for each cytokine from baseline to 12 weeks post intervention (Value at 12 weeks minus value at baseline).

Change in Fasting Serum Lipids and Glucose

时间窗: 12 weeks

Concentration of HDL, LDL, TG, and glucose in the serum after an overnight fast. Value reported as the change in value from baseline to 12 weeks post intervention (Value at 12 weeks minus value at baseline).

Change in Fasting Inflammatory Cytokines

时间窗: 12 weeks

Concentration of inflammatory cytokines (tumor necrosis factor-alpha, interleukin-(IL)1beta, IL-6, IL-10, IL-17, IL-23, interferon-gamma, and granulocyte macrophage-colony stimulating factor) in the serum after an overnight fast. Value reported as the change from baseline to 12 weeks post intervention (Value at 12 weeks minus value at baseline)

次要结局

  • Change in Body Fat Composition(12 weeks)
  • Change in Visceral Adipose Tissue(12 weeks)
  • Change in Body Mass Index (BMI)(12 weeks)
  • Perceptions of Hunger, Fullness, Satiety, and Satisfaction After Mid-day Meal During the Intervention(12 weeks)
  • Gastrointestinal Symptoms of Bloating, Cramping, Discomfort, and Flatulence During the Intervention(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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