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?

Not Applicable

• Conditions: Type 2 diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN32122407
• Lead Sponsor: niversity of Surrey

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-01
• Last Update Posted: 9 January 2023
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 51

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. Be 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

Exclusion Criteria

Participants will be excluded if they:
1. Have a specific medical condition as confirmed by pre-study questionnaires – Type 1 or 2 diabetes, Polycystic Ovary Syndrome (PCOS), Schizophrenia, Bipolar illness, Depression or receiving treatment with antipsychotic medication, or have a history of Cardiovascular Disease (myocardial infarction or stroke)
2. Are currently on certain medications: weight loss, glucose- or lipid-lowering medication (e.g. ‘Metformin’ or ‘Statins’), hypnotics or melatonin supplements
3. Are a smoker
4. Are pregnant
5. Have a history of any circadian or sleep disorder as confirmed by pre-study questionnaires
6. Have habitual irregular sleep patterns on more than 2 nights per week (bed time outside 22:00-1:00 h and wake up time outside 6:00-9:00 h) or a sleep duration on more than 2 nights per week < 7 or > 9 hours
7. Have donated over 400 ml of blood in the three months preceding the study
8. Exceed the defined criteria of pre-study questionnaires:
8.1. BMI: < 25kg/m2
8.2. 30 = Horne-Östberg questionnaire =70
8.3. Pittsburgh Sleep Quality Index: > 5
8.4. Epworth Sleepiness Scale > 9
9. Have travelled across more than two time zones within a month before or during the study
10. Are currently taking part in a clinical trial or another research study or have taken part within the last 3 months
11. Have participated in rotating or night shift work for more than 6 months prior to or during the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Low-density lipoprotein (LDL) cholesterol measured using fasted blood tests at baseline, week 3, 5, 8 and 10<br> 2. Insulin resistance measured using the homeostatic model assessment (HOMA) which utilises fasted glucose and insulin levels, at baseline, week 5 and week 10<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Weight measured using scales at baseline, week 3, 5, 8 and 10<br> 2. Adiposity measured using the gold standard dual-energy x-ray absorptiometry (DEXA) at baseline and week 10<br> 3. Dietary intake assessed through the use of food diaries at baseline, week 2, 4, 7 and 9, as well as 24 hour dietary recalls at baseline, week 3, 5, 8 and 10<br> 4. Food preferences assessed using questionnaires at baseline, week 3, 5 8 and 10, as well as eye tracking tests at baseline, week 5 and week 10<br>