NCT05453617

Intermittent Eating on Sustaining Weight-loss in Obesity

Effects of Intermitting Eating on Weight-Loss Maintenance and Cardiometabolic Risk Factors in Obese Adults: A Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Weight regain after weight loss is a major problem in the treatment of obesity. Two novel types of intermittent fasting recently have received more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast day. This randomized controlled trial aimed to evaluate the effect of TRE and the 5:2 diet on weight loss maintenance and cardiometabolic risk factors after a low-calorie diet in obese adults over 12 months compared to usual health care.

Detailed description

Weight regain after weight loss is a major problem in the treatment of persons with obesity. Two novel types of intermittent fasting recently have received more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast day. Preliminary evidence suggests that both TRE and the 5:2 diet have beneficial effects on weight loss and cardioprotection in humans. Whether TRE or the 5:2 diet is an effective approach for weight-loss maintenance remains unknown. This randomized controlled trial aimed to evaluate the effect of TRE and the 5:2 diet on weight loss maintenance and cardiometabolic risk factors after a low-calorie diet in obese adults over 12 months compared to usual health care. All participants who have achieved greater than 5% of weight loss after a 8-week low-calorie-diet induced weight loss phase, will be assigned to one of the three study groups (TRE, the 5:2 diet and control groups) in a 1:1:1 ratio. Participants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm) over 12 months. Participants in the 5:2 diet group will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days. Participants in the control group were instructed to receive usual health care.

Conditions

• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Time-restricted eating	Participants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm)
BEHAVIORAL	The 5:2 diet	Participants will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days.

Timeline

• Start date: 2022-10-01
• Primary completion: 2025-07-15
• Completion: 2025-07-15
• First posted: 2022-07-12
• Last updated: 2023-11-09

Locations

1 site across 1 country: China