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

NCT06821620 | Completed

• 1 other identifier: SMU_ETHICS_2023-24_626
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Glucose Metabolism Disorders

Outcome Measures

Primary Outcomes (1)

• Glucose response

  Area under the curve

  120 minutes

Secondary Outcomes (3)

• CGM metrics - mean glucose

  14 days

• CGM metrics - Time in range

  14 days

• CGM metrics - glycaemic variability

  14 days

Study Arms (2)

Protein enriched breakfast

EXPERIMENTAL

Dietary Supplement: Breakfast

High carbohydrate breakfast

ACTIVE COMPARATOR

Dietary Supplement: Breakfast

Interventions

Breakfast DIETARY_SUPPLEMENT

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

High carbohydrate breakfast; Protein enriched breakfast

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Mary's University, Twickenham: lead

Study Sites (1)

St Mary's University

London, United Kingdom

Location

MeSH Terms

Conditions

Glucose Metabolism Disorders

Interventions

Breakfast

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Meals; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Breakfast condition - high carbohydrate or protein enriched
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: February 12, 2025
• Study Start: September 9, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)