Non-Alcoholic Fatty Liver DiseaseNCT03972631
Lifestyle Interventions for the Treatment of Non-alcoholic Fatty Liver Disease in Overweight and Obese Adults
A study testing Lifestyle education, Intensive lifestyle intervention and Hypocaloric low-carbohydrate diet plan in people with Non-Alcoholic Fatty Liver Disease and Obesity, run by First Affiliated Hospital of Zhejiang University.
Trial summary
Lifestyle intervention is the most important management of non-alcoholic fatty liver diseases (NAFLD) patients. Weight reductions of 5-10% can improve non-alcoholic steatosis and fibrosis. However, the options for treatment in the clinics are limited. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Obesity
- What is being tested?
- Lifestyle education, Intensive lifestyle intervention and Hypocaloric low-carbohydrate diet plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 292 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to Dec 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or women aged 18-65 years;
- Confirmed diagnosis of NAFLD according to the 2018 Chinese Guidelines for Prevention and Treatment of NAFLD;
- Body mass index (BMI)of 25.0 to 35.0 kg/m2;
- Patients without medicine for treatment of NAFLD;
Who cannot join
- Patients with other diseases that can lead to fatty liver;
- Patients use amiodaron, methotrexate, tamoxifen, glucocorticoid, estrogen, and the other medications that affect weight within 3 months;
- Patients with serious liver dysfunction (AST or/and ALT >3 times of the upper limit of normal), or renal dysfunction (serum creatinine >the upper limit of normal);
- Patients with diseases that need control of dietary protein intake;
- Patients with diseases that affect food digestion and absorption;
- Patients with diagnosed diabetes or those with significantly elevated blood glucose (fasting blood glucose ≥7.0 mmol/L and/or random blood glucose ≥11.1 mmol/L);
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- Patients with severe cardiovascular and cerebrovascular diseases or severe hypertension (Grade 3); anemia; mental illness or memory disorder; epilepsy or antiepileptic treatment;
- Patients with secondary obesity;
- Patients with cancer, active tuberculosis, AIDS and other infectious diseases;
- Pregnancy or lactation;
- Physical disability.
Trial locations and contacts
No sites are listed yet.
About this study
Lifestyle intervention is the most important management of non-alcoholic fatty liver diseases (NAFLD) patients. Weight reductions of 5-10% can improve non-alcoholic steatosis and fibrosis. However, the options for treatment in the clinics are limited. Therefore, in this study, we investigated the effectiveness of different lifestyle intervention strategies in NAFLD patients.
Read the detailed description
This is a multicenter, randomized clinical trial nested within a cohort study in overweight and obese non-alcoholic fatty liver diseases (NAFLD) patients. In this study, 1500 eligible patients will be recruited, and demographic information and clinical data will be collected at baseline. Among these, 292 participants who agree to be randomized will be randomized into two intervention groups, including lifestyle education (LE), and intensive lifestyle intervention with low-carbohydrate diet (ILI), aiming to induce a loss ≥ 10% of initial weight in 3 months. The remainder will chose the treatment which they prefer according to the clinical practice. At the 3th, 6th and 12th month, all the participants will be followed, and data will be collected to study the development of NAFLD in different lifestyle intervention groups.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Obesity
- Being tested
- Lifestyle education, Intensive lifestyle intervention, Hypocaloric low-carbohydrate diet plan
- Keywords
- Lifestyle interventions, Low-carbohydrate diet
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle educationBehavioural
Lifestyle education include the diet principles, physical activity guideline and behavioral strategies.
Intensive lifestyle interventionBehavioural
One to one intensive lifestyle intervention according to the diet and activity plan
Hypocaloric low-carbohydrate diet planBehavioural
A diet plan with restricted calorie and carbohydrate intake
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle education | Placebo comparator | The participants in this group will be provided usual recommendation, including the diet principles, activity guideline and behavioral strategies at baseline. In addition, the participants will have access to an APP, with which the participants could learn more information of body weight management, and keep records of diet, activity and body weight during the study. Receives: Behavioral: Lifestyle education |
| Intensive Lifestyle Intervention | Experimental | The participants in this group will be provided a comprehensive intervention, including goal setting, one to one support by the lifestyle counselors, and meal replacement products, in addition to the information and APP which are provided to the Lifestyle education group. Receives: Behavioral: Lifestyle education; Behavioral: Intensive lifestyle intervention; Behavioral: Hypocaloric low-carbohydrate diet plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI
Measured: baseline, 3 month
Change in liver function biomarkers
ALT, AST
Measured: baseline, 3 month
Liver Stiffness Measurement
LSM is suggested as degree of liver fibrosis
Measured: baseline, 3 month
Fast Ultrasound Attenuation Parameter
FAP is suggested as degree of liver steatosis.
Measured: baseline, 3 month
Secondary outcomes (6)
Change in BMI
Measured: 6 month, 12 month
Change in liver function biomarkers
ALT, AST
Measured: 6 month, 12 month
Change in blood pressure
Measured: baseline, 3 month
Change in lipid
triglyceride, total cholesterol , LDL-C, and HDL-C
Measured: baseline, 3 month
Change in glycemic markers
fasting glucose, fasting insulin, HbA1C
Measured: baseline, 3 month
Change in body composition
muscle mass, fat percentage
Measured: baseline, 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study startJul 2019 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang 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
- None (open label)
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhong, First Affiliated Hospital of Zhejiang University
- Investigators
- Zhong Zhong, MD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972631
- Sponsor's protocol ID
- CHPF2018-NALFD-1
- Status last verified
- Jun 2019
- First submitted
- 31 May 2019
- Last updated
- 13 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu Z, Jin P, Liu Y, Zhang Z, Wu X, Weng M, Cao S, Wang Y, Zeng C, Yang R, Liu C, Sun P, Tian C, Li N, Zeng Q. A comprehensive approach to lifestyle intervention based on a calorie-restricted diet ameliorates liver fat in overweight/obese patients with NAFLD: a multicenter randomized controlled trial in China. Nutr J. 2024 Jun 13;23(1):64. doi: 10.1186/s12937-024-00968-8.
PubMed 38872173Sun P, Huang L, Shuai P, Wan Z, Liu Y, Xue J, Liu Y. Effect of a High Protein, Low Glycemic Index Dietary Intervention on Metabolic Dysfunction-Associated Fatty Liver Disease: A Randomized Controlled Trial. Front Nutr. 2022 Apr 27;9:863834. doi: 10.3389/fnut.2022.863834. eCollection 2022.
PubMed 35571881
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Interventions for the Treatment of Non-alcoholic Fatty Liver Disease in Overweight and Obese Adults
- ClinicalTrials.gov ID
- NCT03972631
- Acronym / sponsor ID
- CHPF2018-NALFD-1
- Conditions
- Non-Alcoholic Fatty Liver Disease, Obesity
- Keywords
- Lifestyle interventions, Low-carbohydrate diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 3 Jun 2019 (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.
Lifestyle intervention is the most important management of non-alcoholic fatty liver diseases (NAFLD) patients. Weight reductions of 5-10% can improve non-alcoholic steatosis and fibrosis. However, the options for treatment in the clinics are limited. Therefore, in this study, we investigated the effectiveness of different lifestyle intervention strategies in NAFLD patients.
Detailed description
This is a multicenter, randomized clinical trial nested within a cohort study in overweight and obese non-alcoholic fatty liver diseases (NAFLD) patients. In this study, 1500 eligible patients will be recruited, and demographic information and clinical data will be collected at baseline. Among these, 292 participants who agree to be randomized will be randomized into two intervention groups, including lifestyle education (LE), and intensive lifestyle intervention with low-carbohydrate diet (ILI), aiming to induce a loss ≥ 10% of initial weight in 3 months. The remainder will chose the treatment which they prefer according to the clinical practice. At the 3th, 6th and 12th month, all the participants will be followed, and data will be collected to study the development of NAFLD in different lifestyle intervention groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle education | Placebo comparator | Behavioral: Lifestyle educationThe participants in this group will be provided usual recommendation, including the diet principles, activity guideline and behavioral strategies at baseline. In addition, the participants will have access to an APP, with which the participants could learn more information of body weight management, and keep records of diet, activity and body weight during the study. |
| Intensive Lifestyle Intervention | Experimental | Behavioral: Lifestyle education, Behavioral: Intensive lifestyle intervention, Behavioral: Hypocaloric low-carbohydrate diet planThe participants in this group will be provided a comprehensive intervention, including goal setting, one to one support by the lifestyle counselors, and meal replacement products, in addition to the information and APP which are provided to the Lifestyle education group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Man or women aged 18-65 years;
- Confirmed diagnosis of NAFLD according to the 2018 Chinese Guidelines for Prevention and Treatment of NAFLD;
- Body mass index (BMI)of 25.0 to 35.0 kg/m2;
- Patients without medicine for treatment of NAFLD;
Key exclusion criteria (11 listed)
- Patients with other diseases that can lead to fatty liver;
- Patients use amiodaron, methotrexate, tamoxifen, glucocorticoid, estrogen, and the other medications that affect weight within 3 months;
- Patients with serious liver dysfunction (AST or/and ALT >3 times of the upper limit of normal), or renal dysfunction (serum creatinine >the upper limit of normal);
- Patients with diseases that need control of dietary protein intake;
- Patients with diseases that affect food digestion and absorption;
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 |
|---|---|---|
| Lifestyle educationLifestyle education include the diet principles, physical activity guideline and behavioral strategies. | Behavioural | Intensive Lifestyle Intervention, Lifestyle education |
| Intensive lifestyle interventionOne to one intensive lifestyle intervention according to the diet and activity plan | Behavioural | Intensive Lifestyle Intervention |
| Hypocaloric low-carbohydrate diet planA diet plan with restricted calorie and carbohydrate intake | Behavioural | Intensive Lifestyle Intervention |
Primary outcome
Change in BMI
Time frame: baseline, 3 month
Change in liver function biomarkers
Time frame: baseline, 3 month
ALT, AST
Liver Stiffness Measurement
Time frame: baseline, 3 month
LSM is suggested as degree of liver fibrosis
Fast Ultrasound Attenuation Parameter
Time frame: baseline, 3 month
FAP is suggested as degree of liver steatosis.
6 secondary outcomes
Change in BMI
Time frame: 6 month, 12 month
Change in liver function biomarkers
Time frame: 6 month, 12 month
Change in blood pressure
Time frame: baseline, 3 month
Change in lipid
Time frame: baseline, 3 month
Change in glycemic markers
Time frame: baseline, 3 month
Change in body composition
Time frame: baseline, 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Derived from this study: PubMed 38872173Liu Z, Jin P, Liu Y, Zhang Z, Wu X, Weng M, Cao S, Wang Y, Zeng C, Yang R, Liu C, Sun P, Tian C, Li N, Zeng Q. A comprehensive approach to lifestyle intervention based on a calorie-restricted diet ameliorates liver fat in overweight/obese patients with NAFLD: a multicenter randomized controlled trial in China. Nutr J. 2024 Jun 13;23(1):64. doi: 10.1186/s12937-024-00968-8.
- Derived from this study: PubMed 35571881Sun P, Huang L, Shuai P, Wan Z, Liu Y, Xue J, Liu Y. Effect of a High Protein, Low Glycemic Index Dietary Intervention on Metabolic Dysfunction-Associated Fatty Liver Disease: A Randomized Controlled Trial. Front Nutr. 2022 Apr 27;9:863834. doi: 10.3389/fnut.2022.863834. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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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.
Zhong Zhong, MD principal investigator
First Affiliated Hospital of Zhejiang University
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle education, Intensive lifestyle intervention and Hypocaloric low-carbohydrate diet plan in people with Non-Alcoholic Fatty Liver Disease and Obesity, run by First Affiliated Hospital of Zhejiang University.
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 11 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: status not confirmed, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhong Liu (+86 13957104885, liuzhongzheyi121@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI (time frame: baseline, 3 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03972631, which also lists 2 linked publications.
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 Jun 2019.