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Ketogenic diet for non-alcoholic fatty liver disease in obese adolescents: a randomized controlled trial

Ketogenic diet for non-alcoholic fatty liver disease in obese adolescents: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050042
Enrollment
Unknown
Registered
2021-08-16
Start date
2021-09-25
Completion date
Unknown
Last updated
2022-04-25

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

Conditions

Non-alcoholic fatty liver disease

Interventions

Group 1: Ketogenic Diet Program (KDP):Advice on ketogenic diet
Group 2: Lifestyle Modification Program (LMP):Advice on a varied balanced diet with an emphasis on fruit and vegetables, and low-fat, low-glycaemic index and low calorific products in appropriate por
personalized exercise regime

Sponsors

Nil
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
14 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Post-pubertal Chinese adolescents aged 14-18 years with primary obesity attending the Obesity and Lipid Disorder Clinic in PWH (with a visit within the previous year and/or with severe obesity at last visit) and potentially from the endocrine clinics of other Hospital Authority (HA) hospitals. 2. Can read Chinese. 3. Signed informed consent by parents and assent by children. 4. Obese adolescents with suspected NAFLD based on previous ultrasound examination or raised liver enzymes.

Exclusion criteria

Exclusion criteria: 1. Patients with Type II diabetes. 2. Patients with Prader Willi Syndrome. 3. Hepatic viral infection. 4. Daily usage of alcohol, from parental or self-report. 5. BMI below 95th centile of local reference. 6. Using steatogenic and/or anti-diabetic drugs. 7. Concurrent participation in any clinical trial, dietary intervention or weight loss program. 8. Concomitant intake of a weight reducing agent. 9. Any chronic medical illness requiring long term regular medical treatment but to exclude common allergic conditions such as asthma, eczema and allergic rhinitis. 10. Unwillingness to attend regular follow up appointments as part of the intervention program.

Design outcomes

Primary

MeasureTime frame
Intrahepatic triglyceride content;

Secondary

MeasureTime frame
Biochemical measurements;Anthropometric measurements;Other internal fat parameters like visceral and intra-abdominal fat;Maintenance effect of the intervention;Impact of the interventions on the microbiome composition;

Countries

China

Contacts

Public ContactEdmund Anthony Severn NELSON

The Chinese University of Hong Kong

tony-nelson@cuhk.edu.hk+852 35052861

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026