MoodNCT03344185
The Effect of Glycaemic Index Variation on Blood Glucose and Mood in Healthy Participants Across the Day
A study testing Low Glycaemic Diet and High Glycaemic Diet in people with Mood and Diet Modification, run by Matthew Grout.
Trial summary
This study provided 24 healthy subjects with two diets that varied in their glycaemic index values. One condition was a low GI diet, whilst the other was a high GI diet. Glucose concentrations and mood were measured throughout each test day. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood, Diet Modification, Glucose, Low 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
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Oct 2016
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65 years of age.
- Willing to participate in the entire study (signed informed consent required)
- Subjects will be eligible for the study if male or female (not pregnant or lactating)
Who cannot join
- Diabetic
- Smoker
- Have any food intolerances or allergies
- History of alcohol or drug misuse
- Diagnosed with any of the following:
- High blood cholesterol
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- 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 or taking any dietary supplements and are unwilling to cease during the testing period
- You are intending to regularly use medication which affects gastrointestinal motility
About this study
This study provided 24 healthy subjects with two diets that varied in their glycaemic index values. One condition was a low GI diet, whilst the other was a high GI diet. Glucose concentrations and mood were measured throughout each test day.
Read the detailed description
Therefore, the aim of this study is to feed to participants meals which differing in their glycaemic index across the course of a day, and thus produce different glycaemic responses. The outcome variables will be blood glucose levels and subjective mood. The purpose of this study is to identify the appropriate times (according to glycaemic response) at which cognitive functioning should be tested. Importantly, this study is also the first step to characterizing glycaemic and cognitive profiles associated with food consumption over a whole day (breakfast, lunch, snack) rather than just one meal (e.g. breakfast), ranging from the most favourable (stable glucose regulation) to the least favourable (variability; many peaks and troughs).
- Conditions
- Mood, Diet Modification, Glucose, Low Blood, Glucose, High Blood
- Being tested
- Low Glycaemic Diet, High Glycaemic Diet
- Keywords
- glycaemic index, mood, glucose, 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 consisted of three low GI meals.
High Glycaemic DietDietary supplement
This intervention consisted of three meals, all with a high GI value.
| Study group | Role | What they receive |
|---|---|---|
| Low GI diet | Experimental | This diet contained three meals, all with a low GI value. 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 Glycaemic profile across the day
Change in blood glucose concentrations (mmol/L)
Measured: Assessed at 0 (baseline), 15, 30, 45, 60, 90, 120 mins after each meal. With 3 meals in a day this totaled 21 assessment point for each day, giving 42 assessment points to compare overall. Data will be reported for the duration of this 3 year PhD award.
Secondary outcomes (1)
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 participants 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 last approximately 5 minutes, giving a total of 60 minutes overall. Data will be reported for the duration of this 3 year PhD award.
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 startJul 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoodStudies 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 diet conditions
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 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
- NCT03344185
- Sponsor's protocol ID
- 2016-032-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
- The Effect of Glycaemic Index Variation on Blood Glucose and Mood in Healthy Participants Across the Day
- ClinicalTrials.gov ID
- NCT03344185
- Acronym / sponsor ID
- 2016-032-DL
- Conditions
- Mood, Diet Modification, Glucose, Low Blood, Glucose, High Blood
- Keywords
- glycaemic index, mood, glucose, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Matthew GroutUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (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 provided 24 healthy subjects with two diets that varied in their glycaemic index values. One condition was a low GI diet, whilst the other was a high GI diet. Glucose concentrations and mood were measured throughout each test day.
Detailed description
Therefore, the aim of this study is to feed to participants meals which differing in their glycaemic index across the course of a day, and thus produce different glycaemic responses. The outcome variables will be blood glucose levels and subjective mood. The purpose of this study is to identify the appropriate times (according to glycaemic response) at which cognitive functioning should be tested. Importantly, this study is also the first step to characterizing glycaemic and cognitive profiles associated with food consumption over a whole day (breakfast, lunch, snack) rather than just one meal (e.g. breakfast), ranging from the most favourable (stable glucose regulation) to the least favourable (variability; many peaks and troughs).
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 diet conditions
| Arm | Type | Receives |
|---|---|---|
| Low GI diet | Experimental | Dietary Supplement: Low Glycaemic DietThis diet contained three meals, all with a low GI value. 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 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 18 and 65 years of age.
- Willing to participate in the entire study (signed informed consent required)
- Subjects will be eligible for the study if male or female (not pregnant or lactating)
Key exclusion criteria (16 listed)
- Diabetic
- Smoker
- Have any food intolerances or allergies
- History of alcohol or drug misuse
- Diagnosed with any of the following:
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 consisted of three low GI meals. | Dietary supplement | Low GI diet |
| High Glycaemic DietThis intervention consisted of three meals, all with a high GI value. | Dietary supplement | High GI diet |
Primary outcome
Change in Glycaemic profile across the day
Time frame: Assessed at 0 (baseline), 15, 30, 45, 60, 90, 120 mins after each meal. With 3 meals in a day this totaled 21 assessment point for each day, giving 42 assessment points to compare overall. Data will be reported for the duration of this 3 year PhD award.
Change in blood glucose concentrations (mmol/L)
1 secondary outcome
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 last approximately 5 minutes, giving a total of 60 minutes overall. Data will be reported for the duration of this 3 year PhD award.
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
Questions about this trial
What is this clinical trial studying?
A study testing Low Glycaemic Diet and High Glycaemic Diet in people with Mood and Diet Modification, run by Matthew Grout.
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 16 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.
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 Glycaemic profile across the day (time frame: Assessed at 0 (baseline), 15, 30, 45, 60, 90, 120 mins after each meal. With 3 meals in a day this totaled 21 assessment point for each day, giving 42 assessment points to compare overall. Data will be reported for the duration of this 3 year PhD award.). 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.