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Interaction of MTNR1B Genotype and Type of Breakfast (Protein-enriched v Carbohydrate-rich) on Postprandial Glucose Response.

Interaction of MTNR1B Genotype and Type of Breakfast (Protein-enriched v Carbohydrate-rich) on Postprandial Glucose Response.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06821620
Enrollment
60
Registered
2025-02-12
Start date
2024-09-09
Completion date
2025-02-28
Last updated
2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucose Metabolism Disorders

Brief 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 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.

Interventions

DIETARY_SUPPLEMENTBreakfast

Breakfast in one condition will be high carbohydrate and in the other protein enriched

Sponsors

St. Mary's University, Twickenham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

Breakfast condition - high carbohydrate or protein enriched

Eligibility

Sex/Gender
ALL
Age
18 Years to 48 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Glucose response120 minutesArea under the curve

Secondary

MeasureTime frameDescription
CGM metrics - mean glucose14 daysmean glucose for 14 days measured using (FreeStyle Libre Pro iQ Continuous Glucose Monitoring System)
CGM metrics - Time in range14 daysTime in range for 14 day period (FreeStyle Libre Pro iQ Continuous Glucose Monitoring System)
CGM metrics - glycaemic variability14 daysglycaemic variability for 14 day period (FreeStyle Libre Pro iQ Continuous Glucose Monitoring System)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026