Effects of Intermittent Dietary Restriction on Cardiometabolic Risk in School-aged Children
NCT Number: NCT06500078
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiovascular Syndrome, Metabolic
Interventions: BEHAVIORAL: Intermittent dietary restriction|BEHAVIORAL: General health education
Sponsor: Children's Hospital of Fudan University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 324
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-13
Completion Date: 2026-12-31
Locations: Children's Hospital of Fudan University, Shanghai, China

Summary:
This randomized trial aims to evaluate the health-promoting effects of intermittent dietary restrictions, including intermittent low-carbohydrate diet (ILCD) and calorie restriction (ICR), in school-aged children with cardiometabolic risk (CMR) compared with general health education based on dietary and physical activity guidelines for Chinese children.

Primary Outcome Measures: Number of participants with reversal of at least one cardiometabolic abnormalities, The primary outcome is a composite outcome that will be measured by combining multiple reverse outcomes of the following cardiometabolic abnormalities: (1) prediabetes; (2) lipid abnormalities; (3) elevated blood pressure. It is defined as occurring if any cardiometabolic abnormality has a reversal outcome at 3rd month of study phrase.

Reversal of cardiometabolic abnormalities is defined as: at 3rd month of study phrase, at least one of the following status changed from abnormal at baseline to normal:

i. Prediabetes; ii. Lipid abnormalities; iii. Elevated blood pressure., At month 3 from baseline
Secondary Outcome Measures: Number of participants with reversal of at least one cardiometabolic abnormalities, It is a composite outcome that will be measured by combining multiple reverse outcomes of the following cardiometabolic abnormalities: (1) prediabetes; (2) lipid abnormalities; (3) elevated blood pressure. It is defined as occurring if any cardiometabolic abnormality has a reversal outcome at 12th month of study phrase.

Reversal of cardiometabolic abnormalities is defined as: at 12th month of study phrase, at least one of the following status changed from abnormal at baseline to normal:

i. Prediabetes; ii. Lipid abnormalities; iii. Elevated blood pressure., At month 12 from baseline|Change in body fat (%), Body fat(%) will be directly derived from non-invasive DEX body composition analyser, assessed by professional operator., From baseline to month 3|Change in the total score of the Wechsler Intelligence Scale for Children, Professionally trained and certified physicians will assess participants using the Wechsler Intelligence Scale for Children at baseline and at month 3 of the study, respectively, to obtain the total score of the scale (continuous variable outcome)., From baseline to month 3|Change in body weight, Body weight is measured according to the Physical Fitness and Health Surveillance of Chinese School Students by trained, certified study staff. It is measured to the nearest 0.1 kg., From baseline to month 3|Change in body weight, Body weight is measured according to the Physical Fitness and Health Surveillance of Chinese School Students by trained, certified study staff. It is measured to the nearest 0.1 kg., From baseline to month 12|Change in waist circumference, Waist circumference is measured to the nearest 0.1 cm using a constant tension tape around the waist at 1 cm below the navel as the subject exhaled. It is calculated as the average value of two measurements., From baseline to month 3|Change in waist circumference, Waist circumference is measured to the nearest 0.1 cm using a constant tension tape around the waist at 1 cm below the navel as the subject exhaled. It is calculated as the average value of two measurements., From baseline to month 12|Change in fibroblast growth factor 21 (FGF-21), FGF-21 will be measured by enzyme-linked immunosorbent assays (R\&D Systems, Inc. USA), using fasting serum samples at baseline and month 3 after intervention., From baseline to month 3