Cardiovascular Syndrome, MetabolicNCT06500078
Effects of Intermittent Dietary Restriction on Cardiometabolic Risk in School-aged Children
A study testing Intermittent dietary restriction and General health education in people with Cardiovascular Syndrome, Metabolic, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Cardiovascular Syndrome, Metabolic
- What is being tested?
- Intermittent dietary restriction and General health education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteChina
- Study dates
- 13 Jul 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 7-18 years at baseline.
- At least one of the following cardio-metabolic abnormalities:
- 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).
- 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).
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai
Yalan Dou, yldou16@fudan.edu.cn
About this study
Official title: Effects of Intermittent Dietary Restriction on Cardiometabolic Risk in School-aged Children: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Cardiovascular Syndrome, Metabolic
- Being tested
- Intermittent dietary restriction, General health education
- Keywords
- Intermittent carbohydrate restriction, Intermittent calorie restriction, Cardiometabolic risk, Children
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent dietary restrictionBehavioural
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 educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent dietary restriction group (ILCD or ICR) | Experimental | 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. Receives: Behavioral: Intermittent dietary restriction; Behavioral: General health education |
| Health education group | Active comparator | Health education group will receive health education based on Chinese guidelines for school-aged children. Receives: Behavioral: General health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Prediabetes; ii. Lipid abnormalities; iii. Elevated blood pressure.
Measured: At month 3 from baseline
Secondary outcomes (8)
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:
- Prediabetes; ii. Lipid abnormalities; iii. Elevated blood pressure.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start13 Jul 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Syndrome, MetabolicStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500078
- Sponsor's protocol ID
- IM_Diet_2.0
- Status last verified
- Oct 2026
- First submitted
- 8 Jul 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intermittent Dietary Restriction on Cardiometabolic Risk in School-aged Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06500078
- Acronym / sponsor ID
- IM_Diet_2.0
- Conditions
- Cardiovascular Syndrome, Metabolic
- Keywords
- Intermittent carbohydrate restriction, Intermittent calorie restriction, Cardiometabolic risk, Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 13 Jul 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent dietary restriction group (ILCD or ICR) | Experimental | Behavioral: Intermittent dietary restriction, Behavioral: General health educationIntermittent 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. |
| Health education group | Active comparator | Behavioral: General health educationHealth education group will receive health education based on Chinese guidelines for school-aged children. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Aged 7-18 years at baseline.
- At least one of the following cardio-metabolic abnormalities:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent dietary restrictionIntermittent 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. | Behavioural | Intermittent dietary restriction group (ILCD or ICR) |
| General health educationGeneral health education based on dietary and physical activity guidelines for Chinese children and adolescents, will regularly send offline and online promotional materials to participants. | Behavioural | Health education group, Intermittent dietary restriction group (ILCD or ICR) |
Primary outcome
Number of participants with reversal of at least one cardiometabolic abnormalities
Time frame: 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.
8 secondary outcomes
Number of participants with reversal of at least one cardiometabolic abnormalities
Time frame: At month 12 from baseline
Change in body fat (%)
Time frame: From baseline to month 3
Change in the total score of the Wechsler Intelligence Scale for Children
Time frame: From baseline to month 3
Change in body weight
Time frame: From baseline to month 3
Change in body weight
Time frame: From baseline to month 12
Change in waist circumference
Time frame: From baseline to month 3
Change in waist circumference
Time frame: From baseline to month 12
Change in fibroblast growth factor 21 (FGF-21)
Time frame: From baseline to month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent dietary restriction and General health education in people with Cardiovascular Syndrome, Metabolic, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yalan Dou (+86 021 64932921, yldou16@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with reversal of at least one cardiometabolic abnormalities (time frame: At month 3 from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.