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Completed

NCT Number: NCT03346746

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

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

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Key information

Conditions

Cognitive Performance Glucose, High Blood Glucose, Low Blood Mood

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading

Reading, Berkshire, RG6 6AL, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Low Glycaemic Diet

Dietary Supplement

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).

High Glycaemic Diet

Dietary Supplement

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).

Primary outcomes

  1. Change in cognitive performance between time points assessed

    Time frame: 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 outcomes

  1. Glycaemic profile

    Time frame: This was measured 23 times a day, for two days, giving a total of 46 times

    Glucose concentration levels

  2. Mood (alertness, anxiety and contentment) using the Bond-Lader (1974) Visual Analogue Scale

    Time frame: 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.

  3. Sleepiness

    Time frame: 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.

  4. Hunger

    Time frame: 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.

  5. Fullness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Matthew Grout

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
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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