Utilizing GI: Exploring an Optimum Glycaemic Profile for Cognitive Function Across the Day

Not Applicable

Completed

• Conditions: Mood; Cognitive Performance; Glucose, Low Blood; Glucose, High Blood
• Interventions: Dietary Supplement: High Glycaemic Diet; Dietary Supplement: Low Glycaemic Diet

• Registration Number: NCT03346746
• Lead Sponsor: Matthew Grout

Brief Summary

This study provides participants with two diets that vary in their glycaemic index values (low vs. high), whilst also measuring cognitive performance and mood.

Detailed Description

Therefore, the current study introduces cognitive testing into study procedures. Participants will consume the favourable and unfavourable conditions (each containing three meals) on separate days following a crossover, randomised, couterbalanced design. The primary dependent variable is cognitive function, whilst secondary measures include glucose and mood. It is hypothesised that the favourable meal profile will be associated with cognitive and physiological benefits relative to the unfavourable meal profile.

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2017-08-30
• Study Completion: 2017-08-30
• Status Verified: 2017-11
• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-14
• Last Update Submitted: 2017-11-14
• Study First Posted: 2017-11-17
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Aged between 18 and 25 years of age
• Willing to participate in the entire study (signed informed consent required)
• Male or female (not pregnant)

Exclusion Criteria

• Suffer from diabetes

• Are anaemic

• 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, and are unwilling to cease during the testing period

• You are intending to regularly use medication which affects gastrointestinal motility

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High GI diet	High Glycaemic Diet	This diet contained three meals, all with a high GI value. This was the High Glycaemic Diet intervention.
Low GI diet	Low Glycaemic Diet	This diet contained three Low GI meals. This was the Low Glycaemic Diet intervention.

Primary Outcome Measures

Name	Time	Method
Change in cognitive performance between time points assessed	This was tested 9 times a day, with two days, giving a total of 18 times. Each battery of four tasks lasted approximately 15 minutes	A participants performance over four cognitive tasks

Secondary Outcome Measures

Name	Time	Method
Glycaemic profile	This was measured 23 times a day, for two days, giving a total of 46 times	Glucose concentration levels
Sleepiness	This takes approximately 30 seconds to complete. Participants were tested six times a day. There were two test days. Giving a total of 12 times, or approximately 6 minutes overall.	This was measured on a custom Visual Analogue Scale. Participants were presented with a 100mm line. At one end the word 'sleepy' appeared, and at the other end 'not sleepy' was present. Participants indicated how sleepy they felt by marking the line closer to the word they currently felt. Scores fell between 0 and 100.
Fullness	This takes approximately 30 seconds to complete. Participants were tested six times a day. There were two test days. Giving a total of 12 times, or approximately 6 minutes overall.	This was measured on a custom Visual Analogue Scale. Participants were presented with a 100mm line. At one end the word 'full' appeared, and at the other end 'not full' was present. Participants indicated how full they felt by marking the line closer to the word they currently felt. Scores fell between 0 and 100.
Mood (alertness, anxiety and contentment) using the Bond-Lader (1974) Visual Analogue Scale	This takes approximately 5 minutes to complete. Participants were tested six times a day. There were two test days. Giving a total of 12 times, or approximately 60 minutes of mood scale completion.	This was comprised of three mood sub-factors; alertness, anxiety, contentment. The VAS provides participants with 16 lines (100mm in length). At each end of every line are two words opposite in meaning, for example 'alert' and 'drowsy'. A participant marks each line closer to the word they feel at that current time. The minimum score is 0 and the maximum is 100, measured in millimetres.
Hunger	This takes approximately 30 seconds to complete. Participants were tested six times a day. There were two test days. Giving a total of 12 times, or approximately 6 minutes overall.	This was measured on a custom Visual Analogue Scale. Participants were presented with a 100mm line. At one end the word 'hungry' appeared, and at the other end 'not hungry' was present. Participants indicated how hungry they felt by marking the line closer to the word they currently felt. Scores fell between 0 and 100.

Trial Locations

Locations (1)

University of Reading; 🇬🇧 Reading, Berkshire, United Kingdom