Gut Microbiota, Insulin Resistance, Intermittent Fasting, Non-Alcoholic Fatty Liver Disease, Obesity
Conditions
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.
Interventions
BEHAVIORALCalorie 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.
Sponsors
Guangdong Medical University
Sun Yat-sen University
Shaoguan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The patient is represented in code
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | Change from baseline body weight at week 8 | Change of body weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipid profile | Change from baseline plasma TG, TC and LDL at week 8 | Plasma lipids levels |
| Insulin resistance | Change from baseline plasma glucose and insulin at week 8 | Plasma glucose and insulin levels |
| Gut microbiota | Change from baseline plasma bile acids and the gut microbiome at week 8 | Changes of blood metabolites and the gut microbiome |
Countries
China
Outcome results
None listed