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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04355910
Other study ID # SGU-05
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date August 31, 2020

Study information

Verified date April 2020
Source Shaoguan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date August 31, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Calorie restriction
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.

Locations

Country Name City State
China Guangdong Medical University Dongguan Guangdong

Sponsors (3)

Lead Sponsor Collaborator
Shaoguan University Guangdong Medical University, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body weight Change of body weight Change from baseline body weight at week 8
Secondary Lipid profile Plasma lipids levels Change from baseline plasma TG, TC and LDL at week 8
Secondary Insulin resistance Plasma glucose and insulin levels Change from baseline plasma glucose and insulin at week 8
Secondary Gut microbiota Changes of blood metabolites and the gut microbiome Change from baseline plasma bile acids and the gut microbiome at week 8
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