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| Name | Class |
|---|---|
| Guangdong Medical University | UNKNOWN |
| Sun Yat-sen University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent fasting mimic-diet (IFD) | Experimental | Restrict 75% energy on two non-consecutive days each week. |
|
| Continuous calorie restriction (CCR) | Active Comparator | A daily 25% energy-restricted Mediterranean-type diet |
|
| Control | No Intervention | No advice to restrict energy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calorie restriction | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Change of body weight | Change from baseline body weight at week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid profile | Plasma lipids levels | Change from baseline plasma TG, TC and LDL at week 8 |
| Insulin resistance | Plasma glucose and insulin levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Medical University | Recruiting | Dongguan | Guangdong | 523808 | China |
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| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| D065626 | Non-alcoholic Fatty Liver Disease |
| D007333 | Insulin Resistance |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D005234 | Fatty Liver |
| D008107 |
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| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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The patient is represented in code
|
| Change from baseline plasma glucose and insulin at week 8 |
| Gut microbiota | Changes of blood metabolites and the gut microbiome | Change from baseline plasma bile acids and the gut microbiome at week 8 |
| Liver Diseases |
| D004066 | Digestive System Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |