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Testing a Modified Intermittent Eating Plan for Weight Loss in Adults with Obesity

Tests an eating plan mixing timed eating and fasting days in adults with obesity.

Plain-language title generated from the registry record
Registry title: Modified Intermittent Eating on Weight Loss (INTEREST-3 Trial)

Key facts

Where
Guangzhou, ChinaSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Source: NCT06302803, who can take part

Where in China

  • Nanfang Hospital of Southern Medical UniversityGuangzhou, ChinaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Nanfang Hospital, Southern Medical University
Trial code
NCT06302803
Record updated
24 June 2024
Original description
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.Read full original descriptionShow less

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

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.

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

Exclusion: 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; 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; 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; 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); 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.

ClinicalTrials.gov NCT06302803