Clinical trial NCT03344185: The Effect of Glycaemic Index Variation on Blood Glucose and Mood in Healthy Participants Across the Day
Official title: The Effect of Glycaemic Index Variation on Blood Glucose and Mood in Healthy Participants Across the Day
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood
Diet Modification
Glucose, Low Blood
Glucose, High Blood
Keywords: glycaemic index
mood
glucose
diet
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants took part in both diet conditions
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Diabetic
* Smoker
* 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

Primary outcomes:
measure: Change in Glycaemic profile across the day
timeFrame: 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.
Secondary outcomes:
measure: Mood (alertness, anxiety and contentment) measured by Bond & Lader (1974) Visual Analogue Scale
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: University of Reading
name: Daniel J Lamport, PhD
role: PRINCIPAL_INVESTIGATOR
References: