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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Change in body weight over 12 months [Срок оценки: Baseline to months 12]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Nanfang Hospital of Southern Medical University — Гуанчжоу

Идентификаторы

NCT: NCT06302803 · NFEC-2024-033

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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