| Study name |
The effects of early versus late time‐restricted feeding on metabolic disease risk factors in adults at increased risk of developing type 2 diabetes: Is there an optimal time to eat? |
| Methods |
Randomised controlled trial |
| Participants |
Inclusion criteria
Participants must:
1. Be aged 18 – 65 years old
2. Have a BMI = 25 kg/m2
3. Have maintained a stable body weight for the 6 months preceding the study (± 2 kg)
4. Be at increased/moderate/high risk of developing type 2 diabetes, as per the Diabetes UK Diabetes Risk Score (scoring = 7)
5. be able and willing to give informed oral and informed written consent
6. Complete and meet the defined criteria of pre‐study questionnaires
7.bBe able and willing to complete daily sleep and food diaries during the study
8. Have an eating period of = 12 hours a day
9. Agree to eat their meals within certain time periods during the day whilst participating in the study
10. Be willing and able to undertake laboratory tests on agreed dates during the study |
| Interventions |
After an initial 1‐week baseline period, participants will be randomly assigned to one of three experimental groups for an intervention period of approximately 10 weeks.
The first (control) group will be asked to maintain their habitual sleep‐wake and feed‐fast routines throughout the intervention period.
The second, ‘early‐TRF’, group will be asked to maintain their habitual sleep‐wake routine, but restrict the duration of their eating times during the day to between 7am and 3pm (± 1 hour).
The third, ‘late‐TRF’, group will also be asked to maintain their habitual sleep‐wake routine, but restrict the duration of their eating times during the day to between 12pm and 8pm (± 1 hour). |
| Outcomes |
1. Low‐density lipoprotein (LDL) cholesterol measured using fasted blood tests at baseline, weeks 3, 5, 8 and 10
2. Insulin resistance measured using the homeostatic model assessment (HOMA) which utilises fasted glucose and insulin levels, at baseline, week 5 and week 10 |
| Starting date |
1. Weight measured using scales at baseline, weeks 3, 5, 8 and 10
2. Adiposity measured using the gold standard dual‐energy x‐ray absorptiometry (DEXA) at baseline and week 10
3. Dietary intake assessed through the use of food diaries at baseline, weeks 2, 4, 7 and 9, as well as 24‐hour dietary recalls at baseline, weeks 3, 5, 8 and 10
4. Food preferences assessed using questionnaires at baseline, weeks 3, 5 8 and 10, as well as eye tracking tests at baseline, week 5 and week 10 |
| Contact information |
s.lynch@surrey.ac.uk |
| Notes |
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