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

NCT ID: NCT06821620

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-09

Study Completion Date

2025-02-28

Brief Summary

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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

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Conditions

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Glucose Metabolism Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Breakfast condition - high carbohydrate or protein enriched

Study Groups

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Protein enriched breakfast

Group Type EXPERIMENTAL

Breakfast

Intervention Type DIETARY_SUPPLEMENT

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

High carbohydrate breakfast

Group Type ACTIVE_COMPARATOR

Breakfast

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Breakfast

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Mary's University, Twickenham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St Mary's University

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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SMU_ETHICS_2023-24_626

Identifier Type: -

Identifier Source: org_study_id

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