Lifestyle Interventions for the Treatment of Non-alcoholic Fatty Liver Disease in Overweight and Obese Adults
NCT ID: NCT03972631
Last Updated: 2019-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
292 participants
INTERVENTIONAL
2019-07-31
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lifestyle education
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.
Lifestyle education
Lifestyle education include the diet principles, physical activity guideline and behavioral strategies.
Intensive Lifestyle Intervention
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.
Lifestyle education
Lifestyle education include the diet principles, physical activity guideline and behavioral strategies.
Intensive lifestyle intervention
One to one intensive lifestyle intervention according to the diet and activity plan
Hypocaloric low-carbohydrate diet plan
A diet plan with restricted calorie and carbohydrate intake
Interventions
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Lifestyle education
Lifestyle education include the diet principles, physical activity guideline and behavioral strategies.
Intensive lifestyle intervention
One to one intensive lifestyle intervention according to the diet and activity plan
Hypocaloric low-carbohydrate diet plan
A diet plan with restricted calorie and carbohydrate intake
Eligibility Criteria
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Inclusion Criteria
* 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;
Exclusion Criteria
* 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);
* 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.
18 Years
65 Years
ALL
No
Sponsors
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First Affiliated Hospital of Zhejiang University
OTHER
Responsible Party
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Liu Zhong
Clinical Professor
Principal Investigators
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Zhong Zhong, MD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Zhejiang University
Central Contacts
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References
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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.
Sun 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.
Other Identifiers
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CHPF2018-NALFD-1
Identifier Type: -
Identifier Source: org_study_id
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