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Completed

NCT Number: NCT06821620

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

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.

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Key information

Conditions

Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–48 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Mary's University

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breakfast

Dietary Supplement

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

Primary outcomes

  1. Glucose response

    Time frame: 120 minutes

    Area under the curve

Secondary outcomes

  1. CGM metrics - mean glucose

    Time frame: 14 days

    mean glucose for 14 days measured using (FreeStyle Libre Pro iQ Continuous Glucose Monitoring System)

  2. CGM metrics - Time in range

    Time frame: 14 days

    Time in range for 14 day period (FreeStyle Libre Pro iQ Continuous Glucose Monitoring System)

  3. CGM metrics - glycaemic variability

    Time frame: 14 days

    glycaemic variability for 14 day period (FreeStyle Libre Pro iQ Continuous Glucose Monitoring System)

Sponsors and collaborators

Lead sponsor

St. Mary's University, Twickenham

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2025
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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