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

Mood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03346746
• Other study ID #: 2016-206-DL
• Status: Completed
• Phase: N/A
• First received: November 9, 2017
• Last updated: November 14, 2017
• Start date: February 1, 2017
• Est. completion date: August 30, 2017

Study information

• Verified date: November 2017
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 30, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Performance
• Glucose, High Blood
• Glucose, Low Blood
• Hyperglycemia
• Hypoglycemia
• Mood

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).
• 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).

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
Matthew Grout

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Glycaemic profile	Glucose concentration levels	This was measured 23 times a day, for two days, giving a total of 46 times
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.