Status:
COMPLETED
Effects of Intermittent Caloric Restriction in Youth With Cardiometabolic Risk
Lead Sponsor:
Children's Hospital of Fudan University
Conditions:
Overweight
Obesity
Eligibility:
All Genders
9-30 years
Phase:
NA
Brief Summary
This is a randomized controlled pilot study to evaluate the effects of intermittent caloric restriction compared with low carbohydrate diet in youth with cardiometabolic risk.
Detailed Description
The National China Health and Nutrition Survey revealed that 42% of overweight children had at least one cardiovascular metabolic risk, such as hyperglycaemia, dyslipidemia or hypertension. Non-pharma...
Eligibility Criteria
Inclusion
- Have at least one of the following cardiometabolic abnormalities:
- Overweight or obesity (central obesity or general obesity)
- Prediabetes: impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT)
- Dyslipidemia
- Elevated blood pressure
- Criteria for cardiometabolic abnormalities:
- Overweight or obesity
- For subjects (9 ≤ age ≤ 18 years) :
- • General obesity: Body mass index higher than the 85th percentile for overweight and the 90th percentile for obesity, based on the references for screening overweight and obesity in Chinese children and adolescents.
- • Central obesity: Waist circumference higher than the 90th percentile of the age and gender-specific reference for screening cardiovascular risk factors in Chinese children and adolescents.
- For subjects ( 19 ≤ age ≤ 30 years) :
- • General obesity: Body mass index between 24.0 and 27.9 kg/m2 for overweight and ≥28 kg/m2 for obesity.
- • Central obesity: Waist circumference ≥85cm for men and ≥80cm for female. Based on recommendation of overweight and obesity in Chinese adults.
- Prediabetes:
- With IFG and/or IGT. IFG: fasting glucose from 5.6 to 6.9 mmol/L; IGT: 2-h glucose in the 75g oral glucose tolerance test from 7.8 to 11.0 mmol/L.
- Based on recommendation of American Diabetes Association.
- Dyslipidemia:
- For subjects (9 ≤ age ≤ 18 years) :
- Triglycerides of ≥1.70 mmol/L or total cholesterol of ≥5.18 mmol/L or lowdensity lipoprotein cholesterol ≥3.37 mmol/L or highdensity lipoprotein cholesterol of ≤1.04 mmol/L. Based on recommendation in Chinese children and adolescents.
- For subjects ( 19 ≤ age ≤ 30 years) :
- Triglycerides of ≥1.7 mmol/L or total cholesterol of ≥5.2 mmol/L or lowdensity lipoprotein cholesterol ≥3.4 mmol/L or highdensity lipoprotein cholesterol of ≤1.0 mmol/L. Based on guideline for the management of dyslipidemia in Chinese adults.
- Elevated blood pressure:
- For subjects (9 ≤ age ≤ 18 years) :
- Blood pressure higher than the 90th percentile of blood pressure age and gender-specific reference standards for Chinese children and adolescents, or blood pressure \>120/80 mmHg.
- For subjects ( 19 ≤ age ≤ 30 years) :
- Systolic blood pressure≥120 mmHg and/or diastolic blood pressure ≥80 mmHg. Based on Chinese guidelines for the management of hypertension.
Exclusion
- Diagnosis of severe diseases such as cardiac insufficiency, severe malnutrition or immunodeficiency.
- History of bariatric surgery.
- Use of antiobesity drugs or supplements.
Key Trial Info
Start Date :
July 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04011995
Start Date
July 12 2018
End Date
December 1 2021
Last Update
March 22 2022
Active Locations (1)
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1
Children's Hospital of Fudan University
Shanghai, China