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

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

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

Study Overview

• Status: Completed
• Conditions: Mood; Cognitive Performance; Glucose, Low Blood; Glucose, High Blood
• Intervention / Treatment: Dietary supplement: Low Glycaemic Diet; Dietary supplement: High Glycaemic Diet

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG6 6AL
      • University of Reading

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low GI diet; This diet contained three Low GI meals. This was the Low Glycaemic Diet intervention.	Dietary supplement: Low Glycaemic Diet; This intervention was a diet that provided participants with three meals with a low GI value. These meals were breakfast (9am), lunch (midday) and a snack (3pm).
Experimental: High GI diet; This diet contained three meals, all with a high GI value. This was the High Glycaemic Diet intervention.	Dietary supplement: High Glycaemic Diet; This intervention was a diet that provided participants with three meals with a high GI value. These meals were breakfast (9am), lunch (midday) and a snack (3pm).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognitive performance between time points assessed	A participants performance over four cognitive tasks	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleepiness	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.	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.
Hunger	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.	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.
Fullness	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.	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.
Glycaemic profile	Glucose concentration levels	This was measured 23 times a day, for two days, giving a total of 46 times
Mood (alertness, anxiety and contentment) using the Bond-Lader (1974) Visual Analogue Scale	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.	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.

Collaborators and Investigators

• Sponsor: Matthew Grout
• Investigators: Principal Investigator: Daniel J Lamport, PhD, University of Reading

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): August 30, 2017
• Study Completion (Actual): August 30, 2017

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: November 14, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 14, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: cognition; diet; mood; glycaemic
• Other Study ID Numbers: 2016-206-DL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No