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临床试验/NCT03344185
NCT03344185已完成不适用

The Effect of Glycaemic Index Variation on Blood Glucose and Mood in Healthy Participants Across the Day

Matthew Grout0 个研究点目标入组 24 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
主要终点
Change in Glycaemic profile across the day

研究概览

简要总结

This study provided 24 healthy subjects with two diets that varied in their glycaemic index values. One condition was a low GI diet, whilst the other was a high GI diet. Glucose concentrations and mood were measured throughout each test day.

详细描述

Therefore, the aim of this study is to feed to participants meals which differing in their glycaemic index across the course of a day, and thus produce different glycaemic responses. The outcome variables will be blood glucose levels and subjective mood. The purpose of this study is to identify the appropriate times (according to glycaemic response) at which cognitive functioning should be tested. Importantly, this study is also the first step to characterizing glycaemic and cognitive profiles associated with food consumption over a whole day (breakfast, lunch, snack) rather than just one meal (e.g. breakfast), ranging from the most favourable (stable glucose regulation) to the least favourable (variability; many peaks and troughs).

研究设计

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

盲法说明

Participants were not told which diet they were consuming each day.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 18 and 65 years of age.
  • Willing to participate in the entire study (signed informed consent required)
  • Subjects will be eligible for the study if male or female (not pregnant or lactating)

排除标准

  • Have any food intolerances or allergies
  • History of alcohol or drug misuse
  • Diagnosed with any of the following:
  • High blood cholesterol
  • High blood pressure
  • Thyroid disorder
  • Heart problems, stroke or any vascular disease in the past 12 months
  • Inflammatory diseases such as rheumatoid arthritis
  • Bone related conditions, such as osteoporosis
  • Renal, gastrointestinal, respiratory, liver disease or cancer
  • You are presently taking part in another clinical trial or research study
  • You are an elite athlete (very high intensity training more than 3 times a week)
  • You are currently on a specific diet or taking any dietary supplements and are unwilling to cease during the testing period
  • You are intending to regularly use medication which affects gastrointestinal motility

结局指标

主要结局

Change in Glycaemic profile across the day

时间窗: Assessed at 0 (baseline), 15, 30, 45, 60, 90, 120 mins after each meal. With 3 meals in a day this totaled 21 assessment point for each day, giving 42 assessment points to compare overall. Data will be reported for the duration of this 3 year PhD award.

Change in blood glucose concentrations (mmol/L)

次要结局

  • Mood (alertness, anxiety and contentment) measured by Bond & Lader (1974) Visual Analogue Scale(This was measured 6 times a day (every 90 minutes starting at 0 minutes/baseline), giving a total of 12 times. Each time last approximately 5 minutes, giving a total of 60 minutes overall. Data will be reported for the duration of this 3 year PhD award.)

研究者

发起方
Matthew Grout
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Matthew Grout

Doctoral Researcher

University of Reading

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