Efficacy and Feasibility of Time-restricted Eating on Cardiometabolic Health in Adults With Overweight/Obesity
Condition: Time Restricted Feeding; Obesity, Abdominal; Cardiometabolic Syndrome
MeSH terms: Obesity; Overweight; Obesity, Abdominal; Metabolic Syndrome
Study type: Interventional

Summary: 
      In Spain, obesity epidemic is one of the leading contributors of chronic disease and
      disability. Obesity is associated with higher morbidity and all-cause mortality risk
      especially when fat is stored in the abdominal area (i.e., increased visceral adipose tissue,
      VAT). Although current approaches such as energy restriction may be effective at reducing
      body fat and improving cardiometabolic health, their long-term adherences are limited.
      Time-restricted eating (TRE; e.g., 8 hours eating: 16 hours fasting on a daily basis) is a
      recently emerged intermittent fasting approach with promising cardiovascular benefits.
      Results from pioneering pilot studies in humans are promising and suggest that simply
      reducing the eating time window from ≥12 to ≤8-10 hours/day improves cardiometabolic health.
      However, currently, there is no consensus regarding whether the TRE eating window should be
      aligned to the early or middle to late part of the day. The EXTREME study will investigate
      the efficacy and feasibility of three different 8 hours TRE schedules (i.e., early, late and
      self-selected) over 12 weeks on VAT (main outcome) and cardiometabolic risk factors
      (secondary outcomes) in adults with overweight/obesity and abdominal obesity. The final goal
      of the EXTREME study is to demonstrate the health benefits of a novel and pragmatic
      intervention for the treatment of obesity and related cardiometabolic risk factors; an
      approach readily adaptable to real-world practice settings, easy for clinicians to deliver,
      and intuitive for patients to implement and maintain in their lives.
    


Intervention name(s): Early time-restricted eating; Late time-restricted eating; Self-selected time-restricted eating
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will eat ad libitum within an 8-hour early eating window starting not later than 10am. No calorie-containing food or beverage intake will be allowed outside the 8-hour eating window. Participants will also receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion; Participants will eat ad libitum within an 8-hour late eating window starting not earlier than 1pm. No calorie-containing food or beverage intake will be allowed outside the 8-hour eating window. Participants will also receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion; Participants will self-selected an 8-hour eating window to eat ad libitum. No calorie-containing food or beverage intake will be allowed outside the 8-hour eating window. Participants will also receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment