Time-Restricted Feeding on Glucose Homeostasis and Quality of Life

Experimental Design

12-week parallel randomised control trial

Recruitment

We will recruit via advertisements outside Dasman using social media and local ads in addition to screening of Dasman Registry for any potential participants. Opportunistic recruitment will also occur by DDI dietitians. Following telephone screening to ensure the potential participant meets initial screening criteria we will carry out a medical screening to ensure the person can take part.

Environment All screening, dietary counselling visits, and placement of the CGM will take place at the Dasman Diabetes Institute (DDI). The institute has extensive space for interventional studies, including screening rooms, body composition assessment and clinical rooms for placement of the CGM monitor.

STUDY INTERVENTIONS

For both groups all participants will be guided towards a 5% weight loss based on individualised energy requirements. The difference will be the hours during which the participants consume their required calories.

• Time restricted feeding group: Will consume their calories between 12pm and 6pm.
• Continuous energy restriction group: Will consume their calories between 8am and 11pm.

Participants will be guided towards their weight loss during one-to-one visits at baseline and every 2 weeks for 12 weeks.

Procedures

• At baseline and follow-up all participants will undergo an oral glucose tolerance test.
• A blood sample will also be taken for HbA1c, lipid profile, fasting insulin, inflammatory factors and a sample for Biobank. The biobank sample will be stored to enable us, with other researchers at DDI to understand the heterogeneity of type 2 diabetes; whether certain people respond to dietary interventions based on their genetic, epigenetic or metabolomic background; and ultimately will help guide clinical care.
• Participants will wear Flash Glucose monitoring or other continuous glucose monitoring device to measure their 24-hour blood glucose concentrations during the seven days preceding the start of the dietary intervention, seven days of the second month, and the final seven days of the third month.
• Participants will also measure their capillary ketones during the first three days of the first month, three days of the second month, and final three days of the third month.
• Medication changes: prandial medications (insulin or sulphonylurea) will be altered to the timing of meal intake. Any reduction in medication due to changes in glucose will be carried out by the patient's doctor.
• A quality of life questionnaire: PAID.
• A 3 day food diary with meal times to check compliance.

Statistical Methods

This is a pilot study. We will recruit 25 people per group. This is based on recommendations for sample sizes for feasibility and pilot studies.