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临床试验/NCT03301948
NCT03301948已完成不适用

The Effects of a Single Day of Mixed Macronutrient Overfeeding on Energy Balance and Metabolic Responses in Healthy Young Men

Leeds Beckett University2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Appetite perceptions assessed using 100mm visual analogue scales

研究概览

简要总结

Healthy male participants are recruited to observe potentially deleterious changes in appetite regulation and metabolic control. Participants will be provided with an energy intake representative of their daily requirements on the first day of one trial and will be provided with an additional 50% energy intake on the first day of another trial. Outcome variables will be assessed during the second day of each trial in response to a fixed mixed macronutrient meal tolerance test.

详细描述

All testing will take place within the Carnegie Research Institute, Leeds Beckett University. We will ask all the participants to visit on five occasions for the completion of a preliminary screening trial and two single-blind counterbalanced experimental trials which each require the participants to visit the laboratory on two consecutive days. The experimental trials will be separated by a minimum of one week.

Visit 1: Preliminary Screening:

Before an individual can take part in the experiment, they will need to undergo screening. Individuals will need to complete a Health Screen Questionnaire. Individuals will be excluded from the study if they are not currently in good health, have any condition that would alter their metabolism and/or have had significant medical problems in the past that may affect the outcomes of the study. Individuals will also be asked to be complete a Three-Factor Eating Questionnaire, to check that they are not restrained eaters, and an International Physical Activity Questionnaire (IPAQ) to ensure that all participants are either sedentary or moderately active. All individuals will be asked to confirm that they have been weight stable for at least six months before participating and that they are not currently dieting. Height, body mass and age will be collected to calculate the energy requirements for the main trials based on the Mifflin equation.

Visits 2, 3, 4 and 5: Experimental Trials:

The participants will be asked to record their food intakes and activity patterns during the three days prior to the first experimental test using a food and physical activity diary. They will then be instructed to repeat this diet and activity pattern prior to the second experimental trial. Participants will be required to arrive at the laboratory for all experimental trials after an overnight fast of at least 10 hours and having refrained from any strenuous activity for 48 hours, and alcohol and caffeine consumption in the previous 24 hours. Two hours before arriving at the laboratory on the day of the experimental trials, participants will be required to ingest 300 mL of water to standardise hydration levels for the trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • weight stable

排除标准

  • any personal history of cardiovascular or metabolic disease
  • currently dieting
  • taking any medication known to influence appetite or metabolic outcomes
  • highly active (IPAQ category 3)

研究组 & 干预措施

Energy Balance

Experimental

Experimental trial where participants are provided with an energy intake equal to their estimated requirements on the first day of the trial.

干预措施: Energy Balance (Other)

Overfeed

Experimental

Experimental trial where participants are provided with 50% higher energy intake than their estimated requirements on the first day of the trial.

干预措施: Overfeed (Other)

结局指标

主要结局

Appetite perceptions assessed using 100mm visual analogue scales

时间窗: 28 hours

Appetite perceptions using 100mm visual analogue scales

Ad libitum energy intake

时间窗: 28 hours

Ad libitum energy intake using an ad libitum pasta meal

Plasma acylated ghrelin concentrations

时间窗: 28 hours

Measured using ELISA from venous blood samples

Plasma peptide YY concentrations

时间窗: 28 hours

Measured using ELISA from venous blood samples

Plasma GLP-1 concentrations

时间窗: 28 hours

Measured using ELISA from venous blood samples

次要结局

  • Palatability perceptions assessed using 100mm visual analogue scales(28 hours)
  • Plasma glucose concentrations(28 hours)
  • Blinding assessment(One week)
  • Plasma insulin concentrations(28 hours)
  • Plasma triglyceride concentrations(28 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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