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临床试验/NCT03863431
NCT03863431Unknown不适用

The Influence of Overfeeding Different Macronutrients on Whole-body Insulin Sensitivity

Loughborough University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年5月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Whole-body insulin sensitivity index

研究概览

简要总结

This study will investigate the effect of high-carbohydrate vs. high-fat overfeeding (130% of energy requirements) on whole body insulin sensitivity.

Following habitual diet, participants will be randomly allocated to either a high-carbohydrate or a high-fat diet intervention for 14-days. On days 0, 7 and 14 participants will undergo anthropometric and metabolic testing (primarily an oral glucose tolerance test [OGTT]).

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •18-40 years
  • •BMI = 18.5-29.9 kg/m2
  • •Male or female
  • •Physically active (> 3 x 30 min moderate exercise per week)
  • •Non-smoker (including the use of vaporisers and e-cigarettes)
  • •Healthy (determined by the School's standard health questionnaire)
  • •No cardiometabolic or inflammatory illness

排除标准

  • •Outside of age-range
  • •Outside BMI range
  • •Inactive (< 3 x 30 min moderate exercise per week)
  • •Taking medication
  • •History of cardiometabolic or inflammatory illness
  • •Vegetarian/ vegan (as the high-fat diet is based on animal fats)
  • •Other dietary restrictions which prevent consumption of the experimental diet
  • •Consumption of probiotics within last 3 months (these influence the gut microbiota)
  • •Participation in another clinical trial
  • •Those with known or suspected food intolerances, allergies or hypersensitivity
  • •Women who are known to be pregnant or who are intending to become pregnant over the course of the study

研究组 & 干预措施

High-fat diet

Active Comparator

Participants will consume a diet rich in fat (approximately 65% of total energy) and low in carbohydrate for 14 days.

Measurements will be made at 0, 7 and 14 days.

干预措施: High-fat diet (Other)

High-carbohydrate diet

Active Comparator

Participants will consume a diet rich in carbohydrate (approximately 70% of total energy) and low in fat for 14 days.

Measurements will be made at 0, 7 and 14 days.

干预措施: High-carbohydrate diet (Other)

结局指标

主要结局

Whole-body insulin sensitivity index

时间窗: The change between pre-, during and post- dietary interventions: Assessed on days 0, 7 and 14

Assessed by oral glucose tolerance test

次要结局

  • Fasting plasma lipid profile (for example total and HDL cholesterol and TAG concentrations; all measured in mmol/L)(Day 0, Day 7, Day 14)
  • Indirect calorimetry(Day 0, Day 7, Day 14)
  • Body Mass Index(Day 0, Day 7, Day 14)
  • Fasting plasma glucose concentration(Day 0, Day 7, Day 14)
  • Subjective appetite ratings(Day 0, Day 7, Day 14)
  • Fasting serum insulin concentration(Day 0, Day 7, Day 14)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carl Hulston

Senior Lecturer Nutrition and Metabolism

Loughborough University

研究点 (1)

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