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OpenTrials
Completed

NCT Number: NCT03344185

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Glycaemic Diet

Dietary Supplement

This intervention consisted of three low GI meals.

High Glycaemic Diet

Dietary Supplement

This intervention consisted of three meals, all with a high GI value.

Primary outcomes

  1. Change in Glycaemic profile across the day

    Time frame: 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)

Secondary outcomes

  1. Mood (alertness, anxiety and contentment) measured by Bond & Lader (1974) Visual Analogue Scale

    Time frame: 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.

    The Bond & Lader VAS provides participants with 16 lines measuring 100mm each. At the ends of each line are two words opposite in meaning. For example, 'alert' and 'drowsy'. A participants marks on the line closer to the word they currently feel. The score from each line is out of 0 to 100.

Sponsors and collaborators

Lead sponsor

Matthew Grout

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 17, 2017
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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