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CompletedNCT06821620Updated May 16, 2025

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

An interventional study of Breakfast in Glucose Metabolism Disorders, sponsored by St. Mary's University, Twickenham. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 48 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by St. Mary's University, Twickenham · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 48 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Glucose Metabolism Disorders
03

In context

Metabolic Diseases

997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.

This study's enrollment of 60 is above the median of 48 across 670 interventional studies indexed under Metabolic Diseases.

Browse Metabolic Diseases studies →

Lead sponsor

St. Mary's University, Twickenham is the lead sponsor of 16 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 48 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Protein enriched breakfast

    Dietary Supplement: Breakfast

  • Active comparator
    High carbohydrate breakfast

    Dietary Supplement: Breakfast

Interventions

  • Dietary supplementBreakfast

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

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What researchers measure

Primary outcomes

  1. Glucose response

    Area under the curve

    Time frame: 120 minutes

Secondary outcomes

  1. CGM metrics - mean glucose

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

    Time frame: 14 days

  2. CGM metrics - Time in range

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

    Time frame: 14 days

  3. CGM metrics - glycaemic variability

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

    Time frame: 14 days

07

Study locations

1 site
  • St Mary's University
    London, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06821620
Lead sponsor
St. Mary's University, Twickenham
Responsible party
Sponsor
First posted
Feb 12, 2025
Start date
Sep 9, 2024
Primary completion
Feb 28, 2025
Completion
Feb 28, 2025
Last update
May 16, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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