Diabetes Mellitus, Type 2NCT03360604
Utilizing Glycaemic Index: An Investigation of the Glycaemia and Cognition in Type 2 Diabetes
A study testing Low Glycaemic Diet and High Glycaemic Diet in people with Diabetes Mellitus, Type 2 and Cognitive Impairment, run by Matthew Grout at 1 site in United Kingdom.
Trial summary
The current study aims to investigate the effects of two GI diets (low vs. high GI) in a sample (25 participants) that has diet controlled type 2 diabetes. This sample has been chosen as those with diabetes have been shown to suffer with poor glucose tolerance, along with the associated deficits such as compromised… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Cognitive Impairment
- 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
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Apr 2018to 1 Dec 2018
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 40 and 70 years of age.
- Willing to participate in the entire study.
- Male of female (not pregnant).
- Currently have type 2 diabetes mellitus.
Who cannot join
- Presence of any food intolerances or allergies.
- Being an elite athlete (very intense exercise more than 3 times a week).
- A history of drug or alcohol abuse.
- Presence of cancer.
- Presence of clinically diagnosed depression.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hugh Sinclair Unit, University of Reading
Reading, Berkshire, RG6 6AL
About this study
Official title: Utilizing Glycaemic Index: An Investigation of the Glycaemic Profiles and Cognitive Performance Displayed by Type 2 Diabetics Across the Course of a Day in Low and High Glycaemic Conditions
The current study aims to investigate the effects of two GI diets (low vs. high GI) in a sample (25 participants) that has diet controlled type 2 diabetes. This sample has been chosen as those with diabetes have been shown to suffer with poor glucose tolerance, along with the associated deficits such as compromised cognitive function. Therefore, it is expected that differences produced by the two diets on blood glucose concentrations and cognitive performance will be greater than those previously seen. If this is the case after analyzing the results, it will provide a potential strategy (diet) for improving glucose tolerance and cognitive performance in a vulnerable section of the population.
Read the detailed description
With the introduction of the glycemic index in 1981, which can be defined as a measure of carbohydrate quality within foods, there has been a wealth of research into its' application to cognitive function. This research has been based on the theory that the availability of blood-borne glucose can have an impact on cognitive performance. This is supported by work that has shown that the brain consumes an immense amount of energy relative to the rest of the body, but possesses minute stores of glycogen which it could convert into its main energy source; glucose. This means the brain is reliant on the glucose supplied to it by the blood, which in turn requires the consumption of foods that can be broken down into glucose.
With this in mind, the vast majority of literature has focussed on the acute effects that foods differing in glycemic values may have on cognitive function, and have found many relevant findings such as less cognitive performance decline across the morning for children who eat a low GI breakfast. This could be explained as a low GI breakfast will contain higher quality carbohydrates, or in other words; slower absorbing carbohydrates, which would suggest the brain has access to a steady supply of glucose across the more.
Interesting work in the field of physiology has proposed the presence of a second meal effect, which can be defined as the glycemic index of a meal having an effect on the glycemic response to a subsequent meal. Surprisingly, there are very few pieces of psychology literature that investigate the possibility of a second cognitive meal effect, which is based on the theory that if a meals' GI can affect the glycemic response to a subsequent meal, then it may also have an effect on cognitive function. However, research into this has found some evidence for such an effect.
Although, there has been a wealth of research into the glycemic index as a whole, the methodology varies greatly from study to study. These problems are most evident when looking at the times that cognitive function tests are administered. For research based upon a theory that relies on availability of blood-borne glucose, the times of cognitive testing do not always align themselves with the time points that the glycemic response indicates are ideal testing times.
An initial study by the investigators looked to resolve the current lack of consistency amongst previous research by providing participants with three meals throughout the course of a day, whilst measuring blood glucose via finger prick. The aim was to identify where the biggest differences in blood glucose occur when looking at the results of a sample of 24 healthy participants. The time points identified would then provide information as to when significant differences in cognitive performance throughout the day may be expected.
A second study fed a larger healthy sample (40 participants) the same meals, but also included a cognitive task battery. Results from the blood glucose concentrations supported results from study 1, with the two diets producing measureable differences in the glycaemic profiles produced across a test day. This is another step into potentially producing a diet that could promote healthy glucose regulation and cognitive function.
The current study aims to investigate the effects of two GI diets (low vs. high GI) in a sample (25 participants) that has diet controlled type 2 diabetes. This sample has been chosen as those with diabetes have been shown to suffer with poor glucose tolerance, along with the associated deficits such as compromised cognitive function. Therefore, it is expected that differences produced by the two diets on blood glucose concentrations and cognitive performance will be greater than those previously seen. If this is the case after analyzing the results, it will provide a potential strategy (diet) for improving glucose tolerance and cognitive performance in a vulnerable section of the population.
- Conditions
- Diabetes Mellitus, Type 2, Cognitive Impairment
- Being tested
- Low Glycaemic Diet, High Glycaemic Diet
- Keywords
- glycaemic index, glycaemia, diabetes mellitus, type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Cognitive Dysfunction, Diabetes Mellitus
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 is a diet consisting of a Low GI breakfast, lunch and snack meal.
High Glycaemic DietDietary supplement
This intervention is a diet consisting of a High GI breakfast, lunch and snack meal.
| Study group | Role | What they receive |
|---|---|---|
| Low GI diet | Experimental | This diet consists of three meals (breakfast, lunch, snack) which all have a low glycaemic index. This is the Low Glycaemic Diet intervention. Receives: Dietary Supplement: Low Glycaemic Diet |
| High GI diet | Experimental | This diet consists of three meals (breakfast, lunch, snack) which all have a high glycaemic index. This is 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 on a Choice Reaction Time task
Specifically, the number of errors and the reaction times of participants are recorded by the software that runs this task (E prime) as it is performed. The number of errors and the mean reaction times are later statistically assessed in SPSS.
Measured: This test lasts 3 minutes. Participants are tested 9 times on each test day. There are two test days. Giving a total of 18 times, or approximately 54 minutes of performing this task across the entire study.
Change in cognitive performance on a Rapid Visual Information Processing task
Specifically, the number of errors and the reaction times of participants are recorded by the software that runs this task (E prime) as it is performed. The number of errors and the mean reaction times are later statistically assessed in SPSS.
Measured: This test lasts 3 minutes. Participants are tested 9 times on each test day. There are two test days. Giving a total of 18 times, or approximately 54 minutes of performing this task across the entire study.
Change in cognitive performance on a combined Choice Reaction Time and Rapid Visual Information Processing task
Specifically, the number of errors and the reaction times of participants are recorded by the software that runs this task (E prime) as it is performed. The number of errors and the mean reaction times are later statistically assessed in SPSS.
Measured: This test lasts 5 minutes. Participants are tested 9 times on each test day. There are two test days. Giving a total of 18 times, or approximately 90 minutes of performing this task across the entire study.
Change in cognitive performance on a Letter Memory Task
Specifically, the number of errors and the reaction times of participants are recorded by the software that runs this task (E prime) as it is performed. The number of errors and the mean reaction times are later statistically assessed in SPSS.
Measured: This test lasts 5 minutes. Participants are tested 9 times on each test day. There are two test days. Giving a total of 18 times, or approximately 90 minutes of performing this task across the entire study.
Secondary outcomes (5)
Glycaemic profile
This is a participants' glucose concentration levels throughout the day, measured via a continuous glucose monitoring system.
Measured: This is measured continuously throughout each day. Each day last approximately 9 hours. There are two test days. Giving a total of 18 hours of continuous glucose monitoring per participant.
Mood (alertness, anxiety and contentment) measured by Bond & Lader (1974) Visual Analogue Scale
The Bond \& Lader VAS provides participants with 16 lines measuring 100mm each. At the ends of each line are two words opposite in meaning. For example, 'alert' and 'drowsy'. A participant marks on the line closer to the word they currently feel. The score from each line is out of 0 to 100.
Measured: This was measured 6 times a day (every 90 minutes starting at 0 minutes/baseline), giving a total of 12 times. Each time lasts approximately 5 minutes, giving a total of 60 minutes overall. Data will be reported for the duration of this 3 year PhD award.
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 posted4 Dec 2017
- Study start4 Apr 2018
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 25 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 ReadingMatthew J Grout, PhD, Study director, University of ReadingJulie A Lovegrove, PhD, Study chair, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360604
- Sponsor's protocol ID
- 2017-151-DL
- Status last verified
- Oct 2019
- First submitted
- 8 Nov 2017
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jenkins DJ, Wolever TM, Taylor RH, Barker H, Fielden H, Baldwin JM, Bowling AC, Newman HC, Jenkins AL, Goff DV. Glycemic index of foods: a physiological basis for carbohydrate exchange. Am J Clin Nutr. 1981 Mar;34(3):362-6. doi: 10.1093/ajcn/34.3.362.
PubMed 6259925Amiel SA. Nutrition of the brain: macronutrient supply. Proc Nutr Soc. 1994 Jul;53(2):401-5. doi: 10.1079/pns19940045. No abstract available.
PubMed 7972154Gomez-Pinilla F. Brain foods: the effects of nutrients on brain function. Nat Rev Neurosci. 2008 Jul;9(7):568-78. doi: 10.1038/nrn2421.
PubMed 18568016Ingwersen J, Defeyter MA, Kennedy DO, Wesnes KA, Scholey AB. A low glycaemic index breakfast cereal preferentially prevents children's cognitive performance from declining throughout the morning. Appetite. 2007 Jul;49(1):240-4. doi: 10.1016/j.appet.2006.06.009. Epub 2007 Jan 16.
PubMed 17224202Wolever TM, Jenkins DJ, Ocana AM, Rao VA, Collier GR. Second-meal effect: low-glycemic-index foods eaten at dinner improve subsequent breakfast glycemic response. Am J Clin Nutr. 1988 Oct;48(4):1041-7. doi: 10.1093/ajcn/48.4.1041.
PubMed 2844076Lamport DJ, Hoyle E, Lawton CL, Mansfield MW, Dye L. Evidence for a second meal cognitive effect: glycaemic responses to high and low glycaemic index evening meals are associated with cognition the following morning. Nutr Neurosci. 2011 Mar;14(2):66-71. doi: 10.1179/1476830511Y.0000000002.
PubMed 21605502Lamport DJ, Lawton CL, Mansfield MW, Moulin CA, Dye L. Type 2 diabetes and impaired glucose tolerance are associated with word memory source monitoring recollection deficits but not simple recognition familiarity deficits following water, low glycaemic load, and high glycaemic load breakfasts. Physiol Behav. 2014 Jan 30;124:54-60. doi: 10.1016/j.physbeh.2013.10.033. Epub 2013 Oct 30.
PubMed 24184411Grout M, Lovegrove JA, Lamport DJ. A multimeal paradigm producing a low glycemic response is associated with modest cognitive benefits relative to a high glycemic response: a randomized, crossover trial in patients with type 2 diabetes. Am J Clin Nutr. 2023 May;117(5):859-869. doi: 10.1016/j.ajcnut.2023.02.017. Epub 2023 Feb 24.
PubMed 36841444
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Glycaemic Index: An Investigation of the Glycaemic Profiles and Cognitive Performance Displayed by Type 2 Diabetics Across the Course of a Day in Low and High Glycaemic Conditions
- ClinicalTrials.gov ID
- NCT03360604
- Acronym / sponsor ID
- 2017-151-DL
- Conditions
- Diabetes Mellitus, Type 2, Cognitive Impairment
- Keywords
- glycaemic index, glycaemia, diabetes mellitus, type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Matthew GroutUniversity, hospital or other
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 4 Dec 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.
The current study aims to investigate the effects of two GI diets (low vs. high GI) in a sample (25 participants) that has diet controlled type 2 diabetes. This sample has been chosen as those with diabetes have been shown to suffer with poor glucose tolerance, along with the associated deficits such as compromised cognitive function. Therefore, it is expected that differences produced by the two diets on blood glucose concentrations and cognitive performance will be greater than those previously seen. If this is the case after analyzing the results, it will provide a potential strategy (diet) for improving glucose tolerance and cognitive performance in a vulnerable section of the population.
Detailed description
With the introduction of the glycemic index in 1981, which can be defined as a measure of carbohydrate quality within foods, there has been a wealth of research into its' application to cognitive function. This research has been based on the theory that the availability of blood-borne glucose can have an impact on cognitive performance. This is supported by work that has shown that the brain consumes an immense amount of energy relative to the rest of the body, but possesses minute stores of glycogen which it could convert into its main energy source; glucose. This means the brain is reliant on the glucose supplied to it by the blood, which in turn requires the consumption of foods that can be broken down into glucose.
With this in mind, the vast majority of literature has focussed on the acute effects that foods differing in glycemic values may have on cognitive function, and have found many relevant findings such as less cognitive performance decline across the morning for children who eat a low GI breakfast. This could be explained as a low GI breakfast will contain higher quality carbohydrates, or in other words; slower absorbing carbohydrates, which would suggest the brain has access to a steady supply of glucose across the more.
Interesting work in the field of physiology has proposed the presence of a second meal effect, which can be defined as the glycemic index of a meal having an effect on the glycemic response to a subsequent meal. Surprisingly, there are very few pieces of psychology literature that investigate the possibility of a second cognitive meal effect, which is based on the theory that if a meals' GI can affect the glycemic response to a subsequent meal, then it may also have an effect on cognitive function. However, research into this has found some evidence for such an effect.
Although, there has been a wealth of research into the glycemic index as a whole, the methodology varies greatly from study to study. These problems are most evident when looking at the times that cognitive function tests are administered. For research based upon a theory that relies on availability of blood-borne glucose, the times of cognitive testing do not always align themselves with the time points that the glycemic response indicates are ideal testing times.
An initial study by the investigators looked to resolve the current lack of consistency amongst previous research by providing participants with three meals throughout the course of a day, whilst measuring blood glucose via finger prick. The aim was to identify where the biggest differences in blood glucose occur when looking at the results of a sample of 24 healthy participants. The time points identified would then provide information as to when significant differences in cognitive performance throughout the day may be expected.
A second study fed a larger healthy sample (40 participants) the same meals, but also included a cognitive task battery. Results from the blood glucose concentrations supported results from study 1, with the two diets producing measureable differences in the glycaemic profiles produced across a test day. This is another step into potentially producing a diet that could promote healthy glucose regulation and cognitive function.
The current study aims to investigate the effects of two GI diets (low vs. high GI) in a sample (25 participants) that has diet controlled type 2 diabetes. This sample has been chosen as those with diabetes have been shown to suffer with poor glucose tolerance, along with the associated deficits such as compromised cognitive function. Therefore, it is expected that differences produced by the two diets on blood glucose concentrations and cognitive performance will be greater than those previously seen. If this is the case after analyzing the results, it will provide a potential strategy (diet) for improving glucose tolerance and cognitive performance in a vulnerable section of the population.
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 consists of three meals (breakfast, lunch, snack) which all have a low glycaemic index. This is the Low Glycaemic Diet intervention. |
| High GI diet | Experimental | Dietary Supplement: High Glycaemic DietThis diet consists of three meals (breakfast, lunch, snack) which all have a high glycaemic index. This is the High Glycaemic Diet intervention. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 40 and 70 years of age.
- Willing to participate in the entire study.
- Male of female (not pregnant).
- Currently have type 2 diabetes mellitus.
Key exclusion criteria (5 listed)
- Presence of any food intolerances or allergies.
- Being an elite athlete (very intense exercise more than 3 times a week).
- A history of drug or alcohol abuse.
- Presence of cancer.
- Presence of clinically diagnosed depression.
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 is a diet consisting of a Low GI breakfast, lunch and snack meal. | Dietary supplement | Low GI diet |
| High Glycaemic DietThis intervention is a diet consisting of a High GI breakfast, lunch and snack meal. | Dietary supplement | High GI diet |
Primary outcome
Change in cognitive performance on a Choice Reaction Time task
Time frame: This test lasts 3 minutes. Participants are tested 9 times on each test day. There are two test days. Giving a total of 18 times, or approximately 54 minutes of performing this task across the entire study.
Specifically, the number of errors and the reaction times of participants are recorded by the software that runs this task (E prime) as it is performed. The number of errors and the mean reaction times are later statistically assessed in SPSS.
Change in cognitive performance on a Rapid Visual Information Processing task
Time frame: This test lasts 3 minutes. Participants are tested 9 times on each test day. There are two test days. Giving a total of 18 times, or approximately 54 minutes of performing this task across the entire study.
Specifically, the number of errors and the reaction times of participants are recorded by the software that runs this task (E prime) as it is performed. The number of errors and the mean reaction times are later statistically assessed in SPSS.
Change in cognitive performance on a combined Choice Reaction Time and Rapid Visual Information Processing task
Time frame: This test lasts 5 minutes. Participants are tested 9 times on each test day. There are two test days. Giving a total of 18 times, or approximately 90 minutes of performing this task across the entire study.
Specifically, the number of errors and the reaction times of participants are recorded by the software that runs this task (E prime) as it is performed. The number of errors and the mean reaction times are later statistically assessed in SPSS.
Change in cognitive performance on a Letter Memory Task
Time frame: This test lasts 5 minutes. Participants are tested 9 times on each test day. There are two test days. Giving a total of 18 times, or approximately 90 minutes of performing this task across the entire study.
Specifically, the number of errors and the reaction times of participants are recorded by the software that runs this task (E prime) as it is performed. The number of errors and the mean reaction times are later statistically assessed in SPSS.
5 secondary outcomes
Glycaemic profile
Time frame: This is measured continuously throughout each day. Each day last approximately 9 hours. There are two test days. Giving a total of 18 hours of continuous glucose monitoring per participant.
Mood (alertness, anxiety and contentment) measured by Bond & Lader (1974) Visual Analogue Scale
Time frame: This was measured 6 times a day (every 90 minutes starting at 0 minutes/baseline), giving a total of 12 times. Each time lasts approximately 5 minutes, giving a total of 60 minutes overall. Data will be reported for the duration of this 3 year PhD award.
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 8 Oct 2019.
- Background: PubMed 6259925Jenkins DJ, Wolever TM, Taylor RH, Barker H, Fielden H, Baldwin JM, Bowling AC, Newman HC, Jenkins AL, Goff DV. Glycemic index of foods: a physiological basis for carbohydrate exchange. Am J Clin Nutr. 1981 Mar;34(3):362-6. doi: 10.1093/ajcn/34.3.362.
- Background: PubMed 7972154Amiel SA. Nutrition of the brain: macronutrient supply. Proc Nutr Soc. 1994 Jul;53(2):401-5. doi: 10.1079/pns19940045. No abstract available.
- Background: PubMed 18568016Gomez-Pinilla F. Brain foods: the effects of nutrients on brain function. Nat Rev Neurosci. 2008 Jul;9(7):568-78. doi: 10.1038/nrn2421.
- Background: PubMed 17224202Ingwersen J, Defeyter MA, Kennedy DO, Wesnes KA, Scholey AB. A low glycaemic index breakfast cereal preferentially prevents children's cognitive performance from declining throughout the morning. Appetite. 2007 Jul;49(1):240-4. doi: 10.1016/j.appet.2006.06.009. Epub 2007 Jan 16.
- Background: PubMed 2844076Wolever TM, Jenkins DJ, Ocana AM, Rao VA, Collier GR. Second-meal effect: low-glycemic-index foods eaten at dinner improve subsequent breakfast glycemic response. Am J Clin Nutr. 1988 Oct;48(4):1041-7. doi: 10.1093/ajcn/48.4.1041.
- Background: PubMed 21605502Lamport DJ, Hoyle E, Lawton CL, Mansfield MW, Dye L. Evidence for a second meal cognitive effect: glycaemic responses to high and low glycaemic index evening meals are associated with cognition the following morning. Nutr Neurosci. 2011 Mar;14(2):66-71. doi: 10.1179/1476830511Y.0000000002.
- Background: PubMed 24184411Lamport DJ, Lawton CL, Mansfield MW, Moulin CA, Dye L. Type 2 diabetes and impaired glucose tolerance are associated with word memory source monitoring recollection deficits but not simple recognition familiarity deficits following water, low glycaemic load, and high glycaemic load breakfasts. Physiol Behav. 2014 Jan 30;124:54-60. doi: 10.1016/j.physbeh.2013.10.033. Epub 2013 Oct 30.
- Derived from this study: PubMed 36841444Grout M, Lovegrove JA, Lamport DJ. A multimeal paradigm producing a low glycemic response is associated with modest cognitive benefits relative to a high glycemic response: a randomized, crossover trial in patients with type 2 diabetes. Am J Clin Nutr. 2023 May;117(5):859-869. doi: 10.1016/j.ajcnut.2023.02.017. Epub 2023 Feb 24.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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
Matthew J Grout, PhD study director
University of Reading
Julie A Lovegrove, PhD study chair
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 Diabetes Mellitus, Type 2 and Cognitive Impairment, 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 4 inclusion and 5 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 8 Oct 2019. 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 on a Choice Reaction Time task (time frame: This test lasts 3 minutes. Participants are tested 9 times on each test day. There are two test days. Giving a total of 18 times, or approximately 54 minutes of performing this task across the entire study.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03360604, which also lists 8 linked publications.
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 8 Oct 2019.