Intermittent Eating on Sustaining Weight-loss in Obesity

NCT05453617 | Unknown

• 1 other identifier: NFEC-2022-155
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

Obesity; Time restricted eating; The 5:2 diet; Weight loss maintenance

Outcome Measures

Primary Outcomes (1)

• Change in body weight over 12 months

  Baseline to months 12

Secondary Outcomes (16)

• Change in body fat composition meassured by DEXA

  Baseline to months 12

• Change in waist circumference

  Baseline to months 12

• Change in body mass index

  Baseline to months 12

• Change in liver fat

  Baseline to months 12

• Change in systolic blood pressure

  Baseline to months 12

Study Arms (3)

The TRE group

EXPERIMENTAL

Participants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm).

Behavioral: Time-restricted eating

The 5:2 diet group

EXPERIMENTAL

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.

Behavioral: The 5:2 diet

Control

NO INTERVENTION

Participants in the control group will receive a general lifestyle counseling.

Interventions

Time-restricted eating BEHAVIORAL

Participants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm)

The TRE group

The 5:2 diet BEHAVIORAL

Participants will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days.

The 5:2 diet group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man or women aged 18-75 years;
• Body mass index (BMI)of 28.0 to 45.0 kg/m2;

You may not qualify if:

• \. History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis;
• \. Diagnosis of type 1 and type 2 diabetes;
• \. History of malignant tumors;
• \. Serious liver dysfunction or chronic kidney disease (AST or ALT \> 3 times the upper limit of normal, or eGFR\<30 ml/min/1.73 m2);
• \. History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
• \. History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months;
• \. History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;
• \. Being a smoker or having been a smoker in the 3 months prior to their screening visit;
• \. Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
• \. Currently participating in weight loss programs or weight change in the past 3 months (\> 5% current body weight) ;
• \. Women who are pregnant or plan to become pregnant;
• \. Patients who cannot be followed for 24 months (due to a health situation or migration);
• \. Patients who are unwilling or unable to give informed consent.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Obesity; Intermittent Fasting

Interventions

Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Huijie Zhang, MD. PhD.

  Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huijie Zhang, MD. PhD.

CONTACT

+86-020-61641635; Huijiezhang2005@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 18, 2022
• First Posted: July 12, 2022
• Study Start: October 1, 2022
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)