Effect of Time-restricted Eating on Behaviour and Metabolism in Overweight Individuals at High Risk of Type 2 Diabetes
Condition: Overweight and Obesity; PreDiabetes
MeSH terms: Overweight; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The aim of the present study is to investigate effects of 12 weeks time-restricted eating on
      behaviour and metabolism in individuals with overweight or obesity at high risk of type 2
      diabetes.
    

Detailed description: 
      Overweight and obese individuals with pre-diabetes or with a family history of diabetes or
      cardiovascular disease (CVD) are at high risk for developing type 2 diabetes (T2D) and CVD.
      Current prevention and treatment of obesity and T2D include energy restricted diets and
      increased levels of physical activity; however, adequate adherence to such strategies is
      difficult, and maintenance is challenging for most individuals, which stresses the need for
      feasible and sustainable interventions.

      Circadian rhythms of behaviour and metabolism are closely related to the daily light/dark
      cycle and sleep-wake patterns and timing of food intake and fasting periods may affect the
      circadian rhythms of metabolic organs. In an evolutionary perspective, the pattern of food
      consumption has been characterised by periods of caloric intake when food was available and
      subsequent periods of fasting 9. This cyclic pattern leads to cycles of absorption and
      storage of energy and utilisation of the energy for e.g. tissue repair, stress resistance and
      vitality where expression of metabolic regulators coordinates with cellular processes,
      leading to efficient metabolism 10. Factors including the 24-hour availability of
      energy-dense foods, busy time schedules, different eating and sleep patterns during weekdays
      and weekends (i.e. 'social jetlag') challenge the feeding-fasting paradigm. Recent data
      suggest that an erratic diurnal eating pattern characterised by food intake largely spread
      throughout hours awake (≥15 h) and a concomitant short fasting period is highly prevalent in
      humans and animal suggest that circadian misalignment of food intake is associated with
      adverse metabolic effects. A number of animal studies and a few small studies in humans have
      reported promising effects of time-restricted eating (TRE), without concomitant dietary
      restrictions, on body weight and other cardiometabolic risk factors. There is a lack of
      randomized controlled trials investigating effect of TRE in individuals at high risk of type
      2 diabetes and cardiovascular diseases.

      The aim of the present study is to investigate effects of 12 weeks TRE on behaviour and
      metabolism in individuals with overweight or obesity at high risk of type 2 diabetes.
      Maintenance will be assessed at a follow-up visit 13 weeks after completion of the trial (26
      weeks). Testing will be conducted at baseline and after 6, 12, and 26 weeks. Participants are
      instructed to follow randomization during one week assessment periods after testing at 6 and
      12 weeks. Therefore, the total duration of the intervention is 13 weeks.
    

Intervention name(s): Time-restricted eating
Intervention type(s): Other
Intervention description(s): Participants will be instructed to eat within a self-selected 10-hour timeframe between 6AM and 8PM every day. All food/beverages except water must be consumed within the time-interval. Staff will help participants select a time-interval that fits into their daily life and optimally fulfil the following guiding principles:
The first food item/beverage of the day should optimally be ingested at least 2 hours after usual wake-up time
The last food item/beverage of the day should optimally be ingested at least 3 hours before usual bed time
Diet is ad libitum and with no further dietary restrictions. Participants will receive advice about a healthy lifestyle according to the national dietary recommendations from the Danish Health Authority.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Overweight; Obesity; Time-restricted eating; Prediabetes