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

Not Applicable

Completed

• Conditions: Glucose Metabolism Disorders

• Registration Number: NCT06821620
• Lead Sponsor: St. Mary's University, Twickenham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-01
• Study Start: 2024-09-09
• Study First Submitted QC: 2025-02-11
• Study First Posted: 2025-02-12
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Glucose response	120 minutes	Area under the curve

Secondary Outcome Measures

Name	Time	Method
CGM metrics - mean glucose	14 days	mean glucose for 14 days measured using (FreeStyle Libre Pro iQ Continuous Glucose Monitoring System)
CGM metrics - Time in range	14 days	Time in range for 14 day period (FreeStyle Libre Pro iQ Continuous Glucose Monitoring System)
CGM metrics - glycaemic variability	14 days	glycaemic variability for 14 day period (FreeStyle Libre Pro iQ Continuous Glucose Monitoring System)

Trial Locations

Locations (1)

St Mary's University; 🇬🇧 London, United Kingdom