Ignite Creation Date:
2024-07-17 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500078
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
Effects of Intermittent Dietary Restriction on Cardiometabolic Risk in School-aged Children
Sponsor:
Childrens Hospital of Fudan University
Organization:
Childrens Hospital of Fudan University
Study Overview
Official Title:
Effects of Intermittent Dietary Restriction on Cardiometabolic Risk in School-aged Children A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 gd for two days per week or an ICR calorie intake is 500-600 kcald 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
Eligible participants will be randomized to receive intermittent dietary restriction including an ILCD carbohydrate intake 50 gd for two days per week or an ICR calorie intake is 500-600 kcald 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None