Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Overweight and Obesity
  • Prediabetes
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Metabolically unhealthy mid-life adults with overweight or obesity who habitually eat for more than 14h/day, will be randomized to a restricted eating window to 10h/d (TRE group) or to their habitual eating window (? 14h, HABIT group), and followed up to 12 months.Masking: Single (Outcomes Assessor)Primary Purpose: Other

Participation Requirements

Age
Between 50 years and 70 years
Gender
Both males and females

Description

American adults have a high prevalence of overweight, obesity and prediabetes. Small weight loss delays the progression to type 2 diabetes and decreases cardiovascular risk, yet adherence to long-term calorie restriction is difficult to sustain. There is an urgency to find effective, easy-to-impleme...

American adults have a high prevalence of overweight, obesity and prediabetes. Small weight loss delays the progression to type 2 diabetes and decreases cardiovascular risk, yet adherence to long-term calorie restriction is difficult to sustain. There is an urgency to find effective, easy-to-implement and to sustain, affordable lifestyle interventions. Restricting the food intake interval, or TRE has been shown in small-scale pilot studies to result in weight loss and improve metabolism, while being less challenging than intervention focusing on calorie restriction. The investigators propose to rigorously assess the efficacy of TRE, administered via a smartphone application, on weight loss and decreased cardiovascular risk. To achieve this goal, metabolically unhealthy mid-life adults with overweight or obesity who habitually eat for more than 14h/day, will be randomized to a restricted eating window to 10h/d (TRE) or to their habitual eating window (?14h, HABIT), and followed up to 12 months. Ambulatory measures of food intake, sleep, physical activity and glucose, and in-patient 24-h well-controlled studies will be done to determine the effect of TRE versus habitual eating duration (HABIT), as well as the mediators of these effects. Hypotheses: 1) TRE vs. HABIT will result in decreased fat mass, measured by quantitative magnetic resonance, and effect mediated via decreased daily total energy intake, measured by double labeled water; 2) TRE vs. HABIT will result in lower insulin resistance, lower glycemia and shift in fuel utilization preferentially to lipid mobilization; 2) Adherence to TRE will associate with the short-term effect (3 months) and the long-term sustainability (12 months) of TRE on fat mass loss. Results from this study will provide important insights into understanding the physiological and molecular interactions between restricting daily eating interval and metabolic function, and could provide evidence for using TRE interventions to improve metabolic health and decrease cardiovascular risk in the large number of mid-life and older Americans in great need of lifestyle intervention

Tracking Information

NCT #
NCT04465721
Collaborators
  • New York University
  • Salk Institute for Biological Studies
Investigators
Principal Investigator: Blandine Laferrère, M.D., Ph.D. Columbia University