Glucose Metabolism DisordersNCT06821620
Interaction of MTNR1B Genotype and Type of Breakfast (Protein-enriched v Carbohydrate-rich) on Postprandial Glucose Response.
A study testing Breakfast in people with Glucose Metabolism Disorders, run by St. Mary's University, Twickenham at 1 site in United Kingdom.
Trial summary
The risk version of the MTNR1B gene (which codes for a melatonin receptor) has been associated with type II diabetes (T2D) and associated physiological markers. People with the risk version of the gene have reduced secretion of insulin when melatonin levels are high (between evening and morning) and impaired glucose… Read more about this study
- Who is it for?
- Ages 18 to 48 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism Disorders
- What is being tested?
- Breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Sep 2024to 28 Feb 2025
- 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 48 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 18-48 years*, not diabetic, not sleep disorder, not relevant medication (weight loss, sleeping, melatonin), not restricted diet, not allergic to oats, milk, wheat, barley or soya, not implanted medical device, such as pacemakers.
Who cannot join
- aged < 18 or > 48 years, diabetic, sleep disorder, eating disorder, taking relevant medication (weight loss, sleeping, melatonin), following a restricted diet, implanted medical device, such as pacemakers.
Trial locations and contacts
1 site in 1 country.
About this study
The risk version of the MTNR1B gene (which codes for a melatonin receptor) has been associated with type II diabetes (T2D) and associated physiological markers. People with the risk version of the gene have reduced secretion of insulin when melatonin levels are high (between evening and morning) and impaired glucose tolerance when they eat late. Previous research suggests eating a protein enriched breakfast can improve glucose response. Therefore, the present study will investigate if the version of the MTNR1B gene that people have is associated with their glucose response after breakfast. Also, whether a protein enriched breakfast improves glucose response in participants with the risk version of the gene. Measures of glucose response collected over the two-week duration of the study will be compared between groups with the different versions of the gene. These findings can be used to provide personalised nutrition advice which may reduce the risk of T2D.
- Conditions
- Glucose Metabolism Disorders
- Being tested
- Breakfast
- Medical subject headings
- Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreakfastDietary supplement
Breakfast in one condition will be high carbohydrate and in the other protein enriched
| Study group | Role | What they receive |
|---|---|---|
| Protein enriched breakfast | Experimental | Not described Receives: Dietary Supplement: Breakfast |
| High carbohydrate breakfast | Active comparator | Not described Receives: Dietary Supplement: Breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose response
Area under the curve
Measured: 120 minutes
Secondary outcomes (3)
CGM metrics - mean glucose
mean glucose for 14 days measured using (FreeStyle Libre Pro iQ Continuous Glucose Monitoring System)
Measured: 14 days
CGM metrics - Time in range
Time in range for 14 day period (FreeStyle Libre Pro iQ Continuous Glucose Monitoring System)
Measured: 14 days
CGM metrics - glycaemic variability
glycaemic variability for 14 day period (FreeStyle Libre Pro iQ Continuous Glucose Monitoring System)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start9 Sep 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism DisordersStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Mary's University, Twickenham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821620
- Sponsor's protocol ID
- SMU_ETHICS_2023-24_626
- Status last verified
- May 2025
- First submitted
- 1 Aug 2024
- Last updated
- 16 May 2025
- Results posted
- 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 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction of MTNR1B Genotype and Type of Breakfast (Protein-enriched v Carbohydrate-rich) on Postprandial Glucose Response.
- ClinicalTrials.gov ID
- NCT06821620
- Acronym / sponsor ID
- SMU_ETHICS_2023-24_626
- Conditions
- Glucose Metabolism Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- St. Mary's University, TwickenhamUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 12 Feb 2025 (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 risk version of the MTNR1B gene (which codes for a melatonin receptor) has been associated with type II diabetes (T2D) and associated physiological markers. People with the risk version of the gene have reduced secretion of insulin when melatonin levels are high (between evening and morning) and impaired glucose tolerance when they eat late. Previous research suggests eating a protein enriched breakfast can improve glucose response. Therefore, the present study will investigate if the version of the MTNR1B gene that people have is associated with their glucose response after breakfast. Also, whether a protein enriched breakfast improves glucose response in participants with the risk version of the gene. Measures of glucose response collected over the two-week duration of the study will be compared between groups with the different versions of the gene. These findings can be used to provide personalised nutrition advice which may reduce the risk of T2D.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein enriched breakfast | Experimental | Dietary Supplement: Breakfast |
| High carbohydrate breakfast | Active comparator | Dietary Supplement: Breakfast |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- aged 18-48 years*, not diabetic, not sleep disorder, not relevant medication (weight loss, sleeping, melatonin), not restricted diet, not allergic to oats, milk, wheat, barley or soya, not implanted medical device, such as pacemakers.
Key exclusion criteria (1 listed)
- aged < 18 or > 48 years, diabetic, sleep disorder, eating disorder, taking relevant medication (weight loss, sleeping, melatonin), following a restricted diet, implanted medical device, such as pacemakers.
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 |
|---|---|---|
| BreakfastBreakfast in one condition will be high carbohydrate and in the other protein enriched | Dietary supplement | High carbohydrate breakfast, Protein enriched breakfast |
Primary outcome
Glucose response
Time frame: 120 minutes
Area under the curve
3 secondary outcomes
CGM metrics - mean glucose
Time frame: 14 days
CGM metrics - Time in range
Time frame: 14 days
CGM metrics - glycaemic variability
Time frame: 14 days
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 16 May 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breakfast in people with Glucose Metabolism Disorders, run by St. Mary's University, Twickenham 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 1 inclusion and 1 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 16 May 2025. 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?
Glucose response (time frame: 120 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 16 May 2025.