Cognitive PerformanceNCT03346746
Utilizing GI: Exploring an Optimum Glycaemic Profile for Cognitive Function Across the Day
A study testing Low Glycaemic Diet and High Glycaemic Diet in people with Cognitive Performance and Glucose, Low Blood, run by Matthew Grout at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Performance, Glucose, Low Blood, Glucose, High Blood
- What is being tested?
- Low Glycaemic Diet and High Glycaemic Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2017to 30 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 25 years of age
- Willing to participate in the entire study (signed informed consent required)
- Male or female (not pregnant)
Who cannot join
- Suffer from diabetes
- Are anaemic
- Smoker
- Have any food intolerances or allergies
- History of alcohol or drug misuse
- Diagnosed with any of the following;
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cognitive Performance, Glucose, Low Blood, Glucose, High Blood, Mood
- Being tested
- Low Glycaemic Diet, High Glycaemic Diet
- Keywords
- cognition, glycaemic, mood, diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Glycaemic DietDietary 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 DietDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| Low GI diet | Experimental | This diet contained three Low GI meals. This was the Low Glycaemic Diet intervention. Receives: Dietary Supplement: Low Glycaemic Diet |
| High GI diet | Experimental | This diet contained three meals, all with a high GI value. This was the High Glycaemic Diet intervention. Receives: Dietary Supplement: High Glycaemic Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive performance between time points assessed
A participants performance over four cognitive tasks
Measured: 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 (5)
Glycaemic profile
Glucose concentration levels
Measured: 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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Feb 2017
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants took part in both conditions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthew Grout
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthew Grout, University of Reading
- Investigators
- Daniel J Lamport, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346746
- Sponsor's protocol ID
- 2016-206-DL
- Status last verified
- Nov 2017
- First submitted
- 9 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing GI: Exploring an Optimum Glycaemic Profile for Cognitive Function Across the Day in Healthy Individuals
- ClinicalTrials.gov ID
- NCT03346746
- Acronym / sponsor ID
- 2016-206-DL
- Conditions
- Cognitive Performance, Glucose, Low Blood, Glucose, High Blood, Mood
- Keywords
- cognition, glycaemic, mood, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Matthew GroutUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All participants took part in both conditions.
| Arm | Type | Receives |
|---|---|---|
| Low GI diet | Experimental | Dietary Supplement: Low Glycaemic DietThis diet contained three Low GI meals. This was the Low Glycaemic Diet intervention. |
| High GI diet | Experimental | Dietary Supplement: High Glycaemic DietThis diet contained three meals, all with a high GI value. This was the High Glycaemic Diet intervention. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged between 18 and 25 years of age
- Willing to participate in the entire study (signed informed consent required)
- Male or female (not pregnant)
Key exclusion criteria (17 listed)
- Suffer from diabetes
- Are anaemic
- Smoker
- Have any food intolerances or allergies
- History of alcohol or drug misuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Glycaemic DietThis 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). | Dietary supplement | Low GI diet |
| High Glycaemic DietThis 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). | Dietary supplement | High GI diet |
Primary outcome
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
5 secondary outcomes
Glycaemic profile
Time frame: 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
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J Lamport, PhD principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Glycaemic Diet and High Glycaemic Diet in people with Cognitive Performance and Glucose, Low Blood, run by Matthew Grout at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.