Modified Intermittent Eating on Weight Loss (INTEREST-3 Trial)

Official title

Effects of Modified Intermittent Eating Strategy on Weight Loss and Cardiometabolic Risk Factors in Obese Adults: a Randomized Clinical Trial

Overview

Calorie restriction (CR) is the most important treatment for weighting loss. In recent years, two novel types of intermittent fasting recently have gained 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 days. However, the effects of dietary strategy of intermittent fasting plus time-restricted eating (modified time-restricted eating: TRE 5 days and fasting 2days per week) on weight loss and cardiometabolic risk factors in obese adults have not been proved. This randomized controlled trial aimed to evaluate the effect of modified time-restricted eating (mTRE) and CR on weight loss and cardiometabolic risk factors in obese adults compared to usual health care over 12 months.

Detailed description

Obesity is becoming a major global public health issue. Calorie restriction (CR) is the most important treatment for weighting loss. In recent years, two novel types of intermittent fasting recently have gained 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 days. However, the effects of dietary strategy of intermittent fasting plus time-restricted eating (modified time-restricted eating: TRE 5 days and fasting 2days per week) on weight loss and cardiometabolic risk factors in obese adults have not been proved. This randomized controlled trial aimed to evaluate the effect of modified time-restricted eating (mTRE) and CR on weight loss and cardiometabolic risk factors in obese adults compared to usual health care over 12 months.

Interventions

• Behavioral Intermittent fasting plus time-restricted eating
  Participants in the mTRE group will be instructed to eat during a window of 8 h (8 am to 4 pm) 5 days and fast (approximately 500-600 kcal per day) 2 days per week.
• Behavioral Calorie restriction
  Participants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without restriction on eating time.

Primary outcome measures

• Change in body weight over 12 months [Time frame: Baseline to months 12]

Secondary outcome measures (12)

• Change in body mass index （BMI） [Time frame: Baseline to months 12]
• Change in waist circumference [Time frame: Baseline to months 12]
• Change in body fat composition meassured by DEXA [Time frame: Baseline to months 12]
• Change in liver fat [Time frame: Baseline to months 12]
• Change in systolic blood pressure [Time frame: Baseline to months 12]
• Change in diastolic blood pressure [Time frame: Baseline to months 12]
• Change in concentration of serum triglyceride [Time frame: Baseline to months 12]
• Change in concentration of serum total cholesterol [Time frame: Baseline to months 12]
• Change in concentration of serum LDL-c [Time frame: Baseline to months 12]
• Change in concentration of HbA1c [Time frame: Baseline to months 12]
• Change in insulin sensitivity [Time frame: Baseline to months 12]
• Change in β cell function [Time frame: Baseline to months 12]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Nanfang Hospital of Southern Medical University — Guangzhou

Identifiers

NCT: NCT06302803 · NFEC-2024-033

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗