NAFLDNCT06579729
Dietary Intervention for Low Free Sugars in Children With Non-alcoholic Fatty Liver Disease
A study testing Dietary intervention for low free sugars in people with NAFLD and Low-free Sugar Dietary, run by China Medical University, China at 1 site in China.
Trial summary
A 48-week dietary intervention program was conducted in children aged 5-14 years with a diagnosis of NAFLD, who were randomized into a low free sugar diet group and a regular diet group. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- NAFLD, Low-free Sugar Dietary, Child Obesity
- What is being tested?
- Dietary intervention for low free sugars
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: above 5 years old and below 14 years old;
- Guardian's consent and signing of informed consent;
- WHO growth and development curves as the reference standard, overweight is defined as BMI greater than or equal to the 85th percentile of the WHO growth curves for children, and obesity is defined as BMI greater than or equal to the 95th percentile of the WHO growth curves for children;
- Liver imaging performance meets the diagnostic criteria of diffuse fatty liver.
Who cannot join
- Age <5 years or >14 years;
- Previous history of alcohol consumption;
- Non-cooperation with the study, inability to comply with the study treatment or study visit.
- Past or active hepatitis B virus infection;
- Past or active hepatitis C virus infection;
- Chronic or acute liver failure;
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- Cholestasis;
- Hepatomegaly;
- Cystic fibrosis;
- α1-antitrypsin deficiency;
- Autoimmune hepatitis;
- Tyrosinemia;
- Galactosemia or any recognized liver disease, any physical condition deemed by a physician to be unable to complete the trial. Physical Condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Intervention for Low Free Sugars in Children With Non-alcoholic Fatty Liver Disease: a Randomized Controlled Trial
A 48-week dietary intervention program was conducted in children aged 5-14 years with a diagnosis of NAFLD, who were randomized into a low free sugar diet group and a regular diet group. The primary objective of this study is to determine whether a low free sugar dietary intervention program improves liver function, fasting glucose, fasting insulin, lipid profile and hepatic steatosis in children with NAFLD. The effects of the intervention will be analyzed and compared at weeks 12, 24 and 48.
- Conditions
- NAFLD, Low-free Sugar Dietary, Child Obesity
- Being tested
- Dietary intervention for low free sugars
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intervention for low free sugarsBehavioural
After baseline data collection, the intervention group received a 30-60 minute educational session with a dietitian and clinicians, including a health education prescription. Interventions occurred at weeks 1, 12 and 24, with routine evaluations of disease, diet, physical activity, and adherence. Follow-ups at 48 weeks assessed NAFLD extent, dietary profile, and health knowledge for both subjects and guardians.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: Dietary intervention for low free sugars |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
NAFLD
NAFLD was diagnosed using liver ultrasonography with a Phillip IU Elite color Doppler ultrasound after a fasting period to reduce gastrointestinal interference.
Measured: At weeks 1, 12 and 24
Dietary
The dietary habits of the subjects were evaluated by a semi-quantitative Food Frequency Questionnaire (FFQ), which was recalled over the past month and included food items, frequency, and amount of intake. The FFQ used in this study covered 72 food items from 11 food groups and 4 frequency categories, including 'average daily, weekly, monthly intake or hardly eat'.
Measured: At weeks 1, 12 and 24
Physical activity level
Physical Activity Questionnaire for Children (PAQ-C) was answered by subjects. The PAQ-C reflects the overall physical activity level of children in the past 7 days.The scale consists of 10 items, .and a 1-5 scale was used to obtain a total score by summing the scores of the individual items. The PAQ-C scale scores < 2.33 defined as low physical activity levels, 2.33-3.66 as moderate physical activity levels, and >3.66 as high physical activity levels.
Measured: At weeks 1, 12 and 24
Secondary outcomes (6)
Height
Height was measured using Height Measuring Ruler (Selcom, Germany) .
Measured: At weeks 1, 12 and 24
Body weight
Body weight was measured using Body Composition Analyzer (DC-13, Parade, Japan).
Measured: At weeks 1, 12 and 24
BMI
BMI (kg/m2) = body weight (kg)/height2 (m2).
Measured: At weeks 1, 12 and 24
Waist circumference
Waist circumference was measured with circumference measuring tape.
Measured: At weeks 1, 12 and 24
Waist-to-height ratio
Waist-to-height ratio (WHtR) = waist circumference (cm)/height (cm).
Measured: At weeks 1, 12 and 24
Blood pressure
Blood pressure was measured using an Omron electronic blood pressure monitor (HBP-1300).
Measured: At weeks 1, 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 Oct 2018
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haonan Zhou, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579729
- Sponsor's protocol ID
- 2018140037
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention for Low Free Sugars in Children With Non-alcoholic Fatty Liver Disease: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06579729
- Acronym / sponsor ID
- 2018140037
- Conditions
- NAFLD, Low-free Sugar Dietary, Child Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 30 Aug 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.
A 48-week dietary intervention program was conducted in children aged 5-14 years with a diagnosis of NAFLD, who were randomized into a low free sugar diet group and a regular diet group. The primary objective of this study is to determine whether a low free sugar dietary intervention program improves liver function, fasting glucose, fasting insulin, lipid profile and hepatic steatosis in children with NAFLD. The effects of the intervention will be analyzed and compared at weeks 12, 24 and 48.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Dietary intervention for low free sugars |
| Control group | No intervention | – |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age: above 5 years old and below 14 years old;
- Guardian's consent and signing of informed consent;
- WHO growth and development curves as the reference standard, overweight is defined as BMI greater than or equal to the 85th percentile of the WHO growth curves for children, and obesity is defined as BMI greater than or equal to the 95th percentile of the WHO growth curves for children;
- Liver imaging performance meets the diagnostic criteria of diffuse fatty liver.
Key exclusion criteria (13 listed)
- Age <5 years or >14 years;
- Previous history of alcohol consumption;
- Non-cooperation with the study, inability to comply with the study treatment or study visit.
- Past or active hepatitis B virus infection;
- Past or active hepatitis C virus infection;
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 |
|---|---|---|
| Dietary intervention for low free sugarsAfter baseline data collection, the intervention group received a 30-60 minute educational session with a dietitian and clinicians, including a health education prescription. Interventions occurred at weeks 1, 12 and 24, with routine evaluations of disease, diet, physical activity, and adherence. Follow-ups at 48 weeks assessed NAFLD extent, dietary profile, and health knowledge for both subjects and guardians. | Behavioural | Intervention group |
Primary outcome
NAFLD
Time frame: At weeks 1, 12 and 24
NAFLD was diagnosed using liver ultrasonography with a Phillip IU Elite color Doppler ultrasound after a fasting period to reduce gastrointestinal interference.
Dietary
Time frame: At weeks 1, 12 and 24
The dietary habits of the subjects were evaluated by a semi-quantitative Food Frequency Questionnaire (FFQ), which was recalled over the past month and included food items, frequency, and amount of intake. The FFQ used in this study covered 72 food items from 11 food groups and 4 frequency categories, including 'average daily, weekly, monthly intake or hardly eat'.
Physical activity level
Time frame: At weeks 1, 12 and 24
Physical Activity Questionnaire for Children (PAQ-C) was answered by subjects. The PAQ-C reflects the overall physical activity level of children in the past 7 days.The scale consists of 10 items, .and a 1-5 scale was used to obtain a total score by summing the scores of the individual items. The PAQ-C scale scores < 2.33 defined as low physical activity levels, 2.33-3.66 as moderate physical activity levels, and >3.66 as high physical activity levels.
6 secondary outcomes
Height
Time frame: At weeks 1, 12 and 24
Body weight
Time frame: At weeks 1, 12 and 24
BMI
Time frame: At weeks 1, 12 and 24
Waist circumference
Time frame: At weeks 1, 12 and 24
Waist-to-height ratio
Time frame: At weeks 1, 12 and 24
Blood pressure
Time frame: At weeks 1, 12 and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention for low free sugars in people with NAFLD and Low-free Sugar Dietary, run by China Medical University, China 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 4 inclusion and 13 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: finished, as of the sponsor's last update on 30 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NAFLD (time frame: At weeks 1, 12 and 24). The study lists 3 primary outcomes in all. 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 30 Aug 2024.