Determining the Effect of Food Ordering on Blood Glucose In Gestational Diabetes Mellitus (DEFI-GDM)

Summary

The goal of this clinical trial is to determine whether the sequence of macronutrient consumption affects post-prandial glycaemia in women with gestational diabetes mellitus.

The main questions it aims to answer are:

* The difference in the magnitude of postprandial rise in blood glucose between the two test meals.
* The difference in the magnitude of postprandial change in serum levels of gut hormones between the two test meals.
* The difference in mean change in pre-post ingestion satiety scores between the two test meals.
* The difference in 24 hour energy and macronutrient intake following the two test meals.

Participants will attend two study visits at the Centre for Public Health, with an interval of at least two days between the visits and complete the following, anthropometric measurements, demographic and appetite questionnaires, glucose measurements, two food diaries and fasting blood samples and the consumption of the study breakfast. Participants will be asked to eat either the protein/fat-based component of the meal (scrambled egg) before or after the carbohydrate-based component (wholemeal toast) on their first visit and on the other visit they will be asked to eat the meal in the reverse order. The order in which this occurs will be randomised and each participant will act as their own control. Researchers will compare the results from participants between the two test meals to see if the order of macronutrient consumption has any effect on post-prandial glycaemia, gut hormones, satiety scores and energy and macronutrient intake.

Conditions

• Gestational Diabetes Mellitus (GDM)

Interventions

OTHER

Visit 1: Protein/fat then carbohydrate. Visit 2: Carbohydrate then protein/fat.

Participants who are randomised to eat the protein/fat-based component (scrambled egg) of the meal before the carbohydrate-based component (wholemeal toast) on their first study visit, will be asked to eat the meal in the reverse order at their second study visit. Meals will be prepared by members of the research team who have completed Food Safety training. Participants will be asked to consume a 440kcal breakfast meal within 10 minutes, approximately 1.5 hours after arrival at their first study visit and approximately 30 minutes after arrival at their second study visit.

OTHER

Visit 1: Carbohydrate then protein/fat. Visit 2: Protein/fat then carbohydrate.

Participants who are randomised to eat the carbohydrate-based component (wholemeal toast) of the meal before the protein/fat-based component (scrambled egg) on their first study visit, will be asked to eat the meal in the reverse order at their second study visit. Meals will be prepared by members of the research team who have completed Food Safety training. Participants will be asked to consume a 440kcal breakfast meal within 10 minutes, approximately 1.5 hours after arrival at their first study visit and approximately 30 minutes after arrival at their second study visit.

Sponsors & Collaborators

• Imperial College London

  collaborator OTHER

• Queen's University, Belfast

  lead OTHER

Principal Investigators

• Hannah O'Hara, MBBS BSc PhD DFSRH MRCGP · Queen's University, Belfast

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-11

Primary Completion

2026-09-30

Completion

2027-02-01

Countries

• United Kingdom

Study Locations