An interventional study of Intermittent dietary restriction and General health education in Cardiovascular Syndrome, Metabolic, sponsored by Children's Hospital of Fudan University. Recruiting at 1 site in China. Open to participants aged 7 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Children's Hospital of Fudan University · Not applicable, Interventional, and Treatment
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Among 89 studies in Metabolic Syndrome with a site in China — 35 open to participants now, 39 under way, 1 of them phase 3. Metabolic Syndrome · China.
Among the 89 studies in Metabolic Syndrome with a site in China, this one is the 6th largest by planned enrollment of the 50 interventional ones that give a count, is one of 10 that started in 2024, is one of 39 with no phase, reaches primary completion later than 32 of the 38 other live ones, and was the 58th registered.
2,117 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
Browse Metabolic Syndrome studies →35 of the 89 studies in Metabolic Syndrome with a site in China are open now. Recruiting first, the newest first:
First Affiliated Hospital of Chongqing Medical University · Sites in China
Ages 18–65
Zhujiang Hospital · Sites in China
Ages 18–60
Liu Yan · Sites in China
Ages 18–65
Hudson Biotech · Sites in China
Ages 18–65
Meihua Ji · Sites in China
Ages 18–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 231 Metabolic Syndrome studies recruiting now, 68 (29%) set no upper age limit and 135 (58%) stop at 75 or younger; 20 take children under 18; 80 take healthy volunteers.
This study: 7 Years to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
89 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 5 · Phase 3 6 · Phase 4 4
First in 2000; this study’s year is marked. 10 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 324 is above the median of 60 across 1,573 interventional studies indexed under Metabolic Syndrome.
Median enrollment 143 across the 50 interventional studies, 1,249 across the 39 observational. Of the 39 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 89 have an industry lead sponsor. The 10 most frequent:
Children's Hospital of Fudan University is the lead sponsor of 268 studies on the registry; 95 are open to participants now.
Children's Hospital of Fudan University has 2 studies filed under Metabolic Syndrome — fewer than ten, so there is no comparison to draw.
12 of the studies in Metabolic Syndrome with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05105321Tang YidaCardiovascular Diseases and Diabetes Prevention Programme in Metabolic Syndrome (CDPP) | 2026-12 |
| NCT07096102Meihua JiEfficacy of a Health Empowerment Theory Based Health Information Literacy Promotion Intervention in Individuals With Metabolic Syndrome | 2026-12-30 |
| NCT07327684Peking Union Medical College HospitalPhotoacoustic/Ultrasound Imaging of Brown Adipose Tissue Activity | 2026-12-31 |
| NCT07822763First Affiliated Hospital of Chongqing Medical UniversityPreoperative Oral Carbohydrate Loading and Gastrointestinal Recovery After Bariatric Surgery in Metabolic Syndrome | 2027-01 |
| NCT07505745Hudson BiotechMOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity | 2027-02-14 |
Add all 12 to your calendar (.ics) → With an account.
Among the 89 studies in Metabolic Syndrome with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At least one of the following cardio-metabolic abnormalities:
Exclusion Criteria:
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.
Behavioral: Intermittent dietary restriction · Behavioral: General health education
Health education group will receive health education based on Chinese guidelines for school-aged children.
Behavioral: General health education
Intermittent dietary restriction will include the ILCD and ICR, which will be self-administered interventions in daily lives. The ILCD intervention will ask participants to restrict carbohydrate intake to ≤ 50 g/d on two consecutive or discontinuous days per week. The ICR intervention will ask participants to restrict caloric intake to 600 kcal/d for boys and 500 kcal/d for girls on two consecutive or discontinuous days per week. At baseline, participants will receive face-to-face oral dietary instructions (e.g., principle of dietary restriction, sample menus, food list with macronutrients). Participants will receive the intervention booklets containing dietary advice and sample menus for diet according to the requirements of the dietary intervention. Participants will be required to record dietary and physical activity data on a regular basis. The total intervention duration will be 12 months, including a 3-month intervention phase and a 9-month self-maintenance phase.
General health education based on dietary and physical activity guidelines for Chinese children and adolescents, will regularly send offline and online promotional materials to participants.
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.
Time frame: At month 3 from baseline
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to month 3
Started Jul 2024 (actual). Primary completion is estimated for Dec 2027, 41 months after the start.
Of 625 non-industry interventional studies with no phase under Metabolic Syndrome, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's planned 41 months is above that.
Counting every sponsor, half of 675 studies reached it within 20 months; a quarter within 9 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Children's Hospital of Fudan University →