A Pilot Study to Evaluate the Effect of Time-Restricted Feeding on Blood Glucose, Insulin Sensitivity and Quality of Life
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Dasman Diabetes Institute
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- HbA1c
Study Overview
Brief Summary
Background: Time-restricted feeding can improve insulin sensitivity, and increase fat oxidation in people with prediabetes independent of weight loss. It may also help people to lose weight. However, it has not been tested in people with type 2 diabetes.
Plan of investigation: Participants meeting the eligibility criteria will be randomized to the TRF arm or the continuous eating arm. Both arms with be given a prescribed dietary plan to help them lose 5% of body weight. In the TRF they will permitted to eat between midday and 6pm. In the continuous eating arm they will be allowed to eat between 8am and 11pm. Participants will attend the nutrition clinic every two weeks to be weighed and be given personalized support to help them follow their assigned diet. Prior to starting the diets outcome measures will be taken: Glycaemia will be measured by a glucose tolerance test, and 7-day continuous glucose monitoring. HbA1c will be taken from fasting blood sample. In addition, the fasting sample will be taken for measurement of insulin, lipid profile and inflammatory markers. We will also use questionnaires to assess quality of life, a 3-day food diary to assess compliance to diet especially meal timings. Capillary ketones will also be used to assess whether compliance to the assigned fasting period. Outcome measures will also be taken during 7 days of the second month, and then the final seven days of the last month on the diet. The primary outcome is HbA1c.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Must agree to follow time restricted feeding protocol if randomized to the TRF arm.
- •Age 21-65 years
- •T2DM with any diabetes medication
- •BMI of 25-45 kg/m2
- •Wake up at a regular time between 5-8 am
- •Able to provide informed consent.
Exclusion Criteria
- •Weight loss of more than 5 kg within the past 6 months
- •HbA1c of <6·5% and >12%
- •Serious current or recent illness including cancer or severe or unstable heart failure.
- •Participation in another clinical research trial.
- •Current treatment with anti-obesity drugs.
- •Substance abuse
- •Learning difficulties
- •Presence of an eating disorder
- •Purging behaviour
- •Pregnancy or consideration of pregnancy
- •Hospital admission for depression or use of antipsychotic drugs.
- •Regularly eat within a <9-hour period each day
- •Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Arms & Interventions
Normal timing of food intake.
Eating between 8am and 11pm.
Intervention: Normal timing of food intake (Behavioral)
TRF
Eating restricted to between midday and 6pm.
Intervention: TRF (Behavioral)
Outcomes
Primary Outcomes
HbA1c
Time Frame: 12 weeks
Change in HbA1c between the intervention and control arms.
Secondary Outcomes
- Diabetes medications(12 weeks)
- Inflammatory markers(12 weeks)
- Insulin sensitivity(12 weeks)
- Body weight(12 weeks)
Investigators
Dr. Ebaa Al Ozairi
Chief Medical Officer
Dasman Diabetes Institute