Clinical trial NCT03346746: Utilizing GI: Exploring an Optimum Glycaemic Profile for Cognitive Function Across the Day
Official title: Utilizing GI: Exploring an Optimum Glycaemic Profile for Cognitive Function Across the Day in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Performance
Glucose, Low Blood
Glucose, High Blood
Mood
Keywords: cognition
glycaemic
mood
diet
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants took part in both conditions.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in cognitive performance between time points assessed
timeFrame: 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 outcomes:
measure: Glycaemic profile
timeFrame: This was measured 23 times a day, for two days, giving a total of 46 times
measure: Mood (alertness, anxiety and contentment) using the Bond-Lader (1974) Visual Analogue Scale
timeFrame: 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.
measure: Sleepiness
timeFrame: 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.
measure: Hunger
timeFrame: 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.
measure: Fullness
timeFrame: 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.
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: Berkshire
Study officials:
affiliation: University of Reading
name: Daniel J Lamport, PhD
role: PRINCIPAL_INVESTIGATOR
References: