Effects of Intermittent Dietary Restriction on Cardiometabolic Risk in School-aged Children

Not Applicable

Recruiting

• Conditions: Cardiovascular Syndrome, Metabolic
• Interventions: Behavioral: General health education; Behavioral: Intermittent dietary restriction

• Registration Number: NCT06500078
• Lead Sponsor: Children's Hospital of Fudan University

Brief 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.

Detailed Description

Childhood obesity comorbid with one or more CMR factors, including hyperglycemia, dyslipidemia, and hypertension, predicts an increased risk for developing cardiovascular disease in adulthood. Lifestyle interventions, including restricting dietary calorie intake and increasing physical activity, have been proposed as the first-line behavioral weight management approaches for pediatric obesity. Long-term adherence to daily dietary restriction is challenging for young populations because they are in a particular period of physical and psychological growth and lifestyle formation. Low-carbohydrate diet and ICR have shown effectiveness in improving cardiometabolic health in adults, however, the evidence supporting the effects of these diets in pediatric populations remains limited.

Eligible participants will be randomized to receive intermittent dietary restriction, including an ILCD (carbohydrate intake ≤ 50 g/d for two days per week) or an ICR (calorie intake is 500-600 kcal/d for two days per week), or general health education based on dietary and physical activity guidelines for Chinese children in daily life. The total study duration will be 12 months consisting of a 3-month intervention phase and a 9-month self-maintenance phase.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-08
• Study Start: 2024-07-13
• Study First Posted: 2024-07-15
• Last Update Submitted: 2024-08-25
• Last Update Posted: 2024-08-27
• Primary Completion: 2026-03-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

• Aged 7-18 years at baseline.

• At least one of the following cardio-metabolic abnormalities:

  1. Prediabetes (Impaired fasting glucose: 5.6 ≤ fasting blood glucose level ≤ 6.9 mmol/L; or Impaired glucose tolerance: 7.8 ≤ blood glucose level after 2 hours postprandial ≤ 11.0 mmol/L).
  2. Lipid abnormalities (High-density lipoprotein cholesterol ≤ 1.04 mmol/L; or Low-density lipoprotein cholesterol ≥ 3.37 mmol/L; or Triglycerides ≥ 1.70 mmol/L, or Total cholesterol ≥ 5.18 mmol/L).
  3. Elevated blood pressure (Systolic/diastolic blood pressure consistently higher than the 90th percentile for gender, age, and height; or systolic/diastolic blood pressure ≥ 120/80 mmHg).

Exclusion Criteria

• Previously diagnosed with heart failure, severe malnutrition, immune deficiency, liver or kidney disease, cancer, or other diseases deemed unsuitable for participation.
• Had a history of bariatric surgery.
• Used weight loss pills or supplements in the last three months.
• Other situations unsuitable for participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health education group	General health education	Health education group will receive health education based on Chinese guidelines for school-aged children.
Intermittent dietary restriction group (ILCD or ICR)	General health education	Intermittent dietary restriction group will receive ILCD or ICR intervention. ILCD will be conducted as a carbohydrate intake restriction of ≤ 50 g/day for two consecutive or discontinuous days per week, and ICR will be conducted as a calorie intake restriction of 500-600 kcal/day for two consecutive or discontinuous days per week.
Intermittent dietary restriction group (ILCD or ICR)	Intermittent dietary restriction	Intermittent dietary restriction group will receive ILCD or ICR intervention. ILCD will be conducted as a carbohydrate intake restriction of ≤ 50 g/day for two consecutive or discontinuous days per week, and ICR will be conducted as a calorie intake restriction of 500-600 kcal/day for two consecutive or discontinuous days per week.

Primary Outcome Measures

Name	Time	Method
Number of participants with reversal of at least one cardiometabolic abnormalities	At month 3 from baseline	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.

Secondary Outcome Measures

Name	Time	Method
Number of participants with reversal of at least one cardiometabolic abnormalities	At month 12 from baseline	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.
Change in body fat (%)	From baseline to month 3	Body fat(%) will be directly derived from non-invasive DEX body composition analyser, assessed by professional operator.
Change in body weight	From baseline to month 12	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.
Change in the total score of the Wechsler Intelligence Scale for Children	From baseline to month 3	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).
Change in waist circumference	From baseline to month 12	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.
Change in fibroblast growth factor 21 (FGF-21)	From baseline to month 3	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.

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, China