Back to resultsIntermittent Fasting in Nonalcoholic Fatty Liver Disease
Primary Purpose
Intermittent Fasting, Non-Alcoholic Fatty Liver Disease, Insulin Resistance
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Calorie restriction
Sponsored by
About this trial
This is an interventional treatment trial for Intermittent Fasting
Eligibility Criteria
Inclusion Criteria:
- The diagnosed criteria of fatty liver by ultrasound were presence of two of the three following criteria: increased hepatic echogenicity compared with cortical of the right kidney, blurring of liver vasculature, and deep attenuation of the ultrasonographic signal.
Exclusion Criteria:
- Excessive alcohol consumption (ethanol > 140 g/wk for men and > 70 g/wk for women), cirrhosis, viral hepatitis, cardiovascular disease, cancer, any consumption of nonsteroidal anti-inflammatory drugs, corticosteroids or prescriptive medicine that affect liver function, lipid and glucose metabolism.
Sites / Locations
- Guangdong Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Intermittent fasting mimic-diet (IFD)
Continuous calorie restriction (CCR)
Control
Arm Description
Restrict 75% energy on two non-consecutive days each week.
A daily 25% energy-restricted Mediterranean-type diet
No advice to restrict energy
Outcomes
Primary Outcome Measures
Body weight
Change of body weight
Secondary Outcome Measures
Lipid profile
Plasma lipids levels
Insulin resistance
Plasma glucose and insulin levels
Gut microbiota
Changes of blood metabolites and the gut microbiome
Full Information
NCT ID
NCT04355910
First Posted
April 16, 2020
Last Updated
April 19, 2020
Sponsor
Shaoguan University
Collaborators
Guangdong Medical University, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT04355910
Brief Title
Intermittent Fasting in Nonalcoholic Fatty Liver Disease
Official Title
Effects of Intermittent and Continuous Calorie Restriction on Body Weight and Metabolism in Adults With Nonalcoholic Fatty Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
August 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shaoguan University
Collaborators
Guangdong Medical University, Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Although preliminary evidence suggests that intermittent fasting mimic-diet (IFD) exerts stronger effects on body weight and metabolic parameters, which may link obesity, non-alcoholic fatty liver disease (NAFLD) and major chronic diseases, compared with continuous calorie restriction (CCR), there is a lack of well-powered intervention studies. This randomized controlled trial will test whether IFD, operationalized as the "5:2 diet," has stronger effects on anthropometric and body composition characteristics, and circulating metabolic biomarkers than CCR and a control regimen in adults with NAFLD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Fasting, Non-Alcoholic Fatty Liver Disease, Insulin Resistance, Obesity, Gut Microbiota
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The patient is represented in code
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intermittent fasting mimic-diet (IFD)
Arm Type
Experimental
Arm Description
Restrict 75% energy on two non-consecutive days each week.
Arm Title
Continuous calorie restriction (CCR)
Arm Type
Active Comparator
Arm Description
A daily 25% energy-restricted Mediterranean-type diet
Arm Title
Control
Arm Type
No Intervention
Arm Description
No advice to restrict energy
Intervention Type
Behavioral
Intervention Name(s)
Calorie restriction
Intervention Description
Participants randomized to IFD were asked to restrict energy and carbohydrate on two non-consecutive days each week (75% energy restriction) and to consume a plant foods-based diet that met their estimated energy requirements for the remaining 5 d of the week.
The CCR group was prescribed a daily plant foods-based diet that was relatively low in fat with moderate energy-restriction (25% energy restriction).
The plant foods-based diet included adequate fruit and vegetable, nuts and seeds, whole-grain cereals, olive oil, fish and seafood, a moderate consumption of dairy products, poultry, eggs, and lean red meat.
Primary Outcome Measure Information:
Title
Body weight
Description
Change of body weight
Time Frame
Change from baseline body weight at week 8
Secondary Outcome Measure Information:
Title
Lipid profile
Description
Plasma lipids levels
Time Frame
Change from baseline plasma TG, TC and LDL at week 8
Title
Insulin resistance
Description
Plasma glucose and insulin levels
Time Frame
Change from baseline plasma glucose and insulin at week 8
Title
Gut microbiota
Description
Changes of blood metabolites and the gut microbiome
Time Frame
Change from baseline plasma bile acids and the gut microbiome at week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The diagnosed criteria of fatty liver by ultrasound were presence of two of the three following criteria: increased hepatic echogenicity compared with cortical of the right kidney, blurring of liver vasculature, and deep attenuation of the ultrasonographic signal.
Exclusion Criteria:
Excessive alcohol consumption (ethanol > 140 g/wk for men and > 70 g/wk for women), cirrhosis, viral hepatitis, cardiovascular disease, cancer, any consumption of nonsteroidal anti-inflammatory drugs, corticosteroids or prescriptive medicine that affect liver function, lipid and glucose metabolism.
Facility Information:
Facility Name
Guangdong Medical University
City
Dongguan
State/Province
Guangdong
ZIP/Postal Code
523808
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peiwen Zhang, M. D.
Phone
86-769-22896572
Email
313743920@qq.com
First Name & Middle Initial & Last Name & Degree
Xuebin Gao, M. D.
Phone
86-18819747104
Email
401779114@qq.com
First Name & Middle Initial & Last Name & Degree
Peiwen Zhang, M. D.
First Name & Middle Initial & Last Name & Degree
Honghui Guo, Ph. D.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Intermittent Fasting in Nonalcoholic Fatty Liver Disease
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