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A Multicenter Randomized Controlled Trial on the Effects of High-Protein Energy-Restricted Diet versus Balanced Energy-Restricted Diet on Liver Fat Content in Obese Children and Adolescents

A Multicenter Randomized Controlled Trial on the Effects of High-Protein Energy-Restricted Diet versus Balanced Energy-Restricted Diet on Liver Fat Content in Obese Children and Adolescents

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128426
Enrollment
Unknown
Registered
2026-07-20
Start date
2026-07-22
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood and adolescent obesity

Interventions

Energy-restricted balanced diet group:Energy-restricted balanced diet
Energy-restricted high-protein diet group:Energy-restricted high-protein diet

Sponsors

Jinan Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
9 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged 9 years or older but under 17 years old; 2.Based on the gender and age-specific BMI thresholds specified in WS/T 586-2018 "Screening for Overweight and Obesity in School-Age Children and Adolescents", those with BMI exceeding the threshold are classified as obese. 3.Can complete a 17-day closed training camp and be able to follow unified management of diet, exercise, courses and schedule. 4.The guardian voluntarily signs a written informed consent form, and the children and adolescents sign the informed confirmation form after understanding the research information.

Exclusion criteria

Exclusion criteria: 1.The screening indicates a suspected case of diabetes that requires further diagnosis and treatment, or there are obvious metabolic diseases that the research physician deems unsuitable for participating in the unified weight loss training. 2.Significantly abnormal liver and kidney functions, severe heart and lung diseases, uncontrolled hypertension or active acute infections; 3.Severe bone and joint diseases, neurological and muscular disorders, or movement restrictions prevent the implementation of unified movement management. 4.Secondary obesity, or the presence of diseases that may significantly affect weight, metabolism or body composition assessment; 5.Recently, the use of medications that may significantly affect weight or metabolism; 6.For clinical situations where there is a clear food allergy to the main ingredients of the recipe, severe intolerance, or where an inappropriate high-protein diet is required; 7.Known or suspected pregnancy, or other situations where DXA examination is not appropriate; 8.The researchers identified cases where the physicians judged that the participants were not safe to participate in the study, were unable to complete the key evaluations, or had insufficient compliance.

Design outcomes

Primary

MeasureTime frame
Absolute change in liver fat content measured by MRI-PDFF;Change in BMI-for-age z-score;

Secondary

MeasureTime frame
Intraocular pressure measurement;Change in appendicular lean soft tissue mass;Changes in liver function, renal function, uric acid, and inflammatory markers;Adverse events and serious adverse events;Change in percentage of the 95th percentile for BMI;Change in waist circumference;Changes in blood lipid profile;Change in handgrip strength;Changes in glucose metabolism markers;Change in body fat percentage;Change in controlled attenuation parameter;Ophthalmoscopic examination findings;Percentage change in body weight;Change in waist-to-height ratio;Change in fat mass index;Routine refraction examination;Change in liver stiffness measurement;Change in lean mass index;Change in total lean soft tissue mass;Change in body mass index;Change in total body fat mass;

Countries

China

Contacts

Public ContactYongfeng Song

Jinan Central Hospital

syf198506@163.com+86 531 55865208

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026