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The effects of intermittent fasting diet in comparison with low-calorie diet on lipid profile, glycemic status, and liver fibrosis in patients with non-alcoholic fatty liver (NAFLD): a study protocol for a randomized controlled clinical trial.

BMC nutrition
December 8, 2023
Mehdi Karimi et al. (7 authors)
Journal ArticleHuman Study
Study Details

Study Goal

The researchers aimed to compare the effects of 16:8 Intermittent Fasting (IF) versus a low-calorie diet (LCD) on liver steatosis, fibrosis, lipid profile, glycemic status, and anthropometric measurements in overweight and obese patients with NAFLD.

Results Summary

The abstract does not provide specific results, but the study design suggests it will evaluate IF's impact on liver health and metabolic markers. Limitations include the small sample size (52 participants) and lack of reported outcomes in the abstract.

Population

Overweight and obese patients with NAFLD (52 participants).

Effective Dosage

16:8 IF (fasting from 8 P.M. to 12 P.M. the next day).

Duration

12 weeks.

Interactions

None mentioned.

Extracted Claims (8)
InterventionDirectionEndpointPopulationDosageImpactClaim #
intermittent fasting (IF) diet
decrease
obesity and related complications
-
-
has been suggested as an alternative treatment
#1
intermittent fasting (IF)
increase
metabolic health
-
-
potential positive effects
#2
intermittent fasting (IF)
decrease
oxidative stress
patients with NAFLD
-
reduction
#3
IF diet
neutral
lipid profile, glycemic status, and liver fibrosis
patients with NAFLD
-
effect
#4
low-calorie diet (LCD)
neutral
lipid profile, glycemic status, and liver fibrosis
patients with NAFLD
-
effect
#5
16:8 IF
neutral
-
overweight and obese patients with NAFLD
-
receive
#6
low-calorie (55% carbohydrate- 30% fat, 15% protein) diet
neutral
-
overweight and obese patients with NAFLD
-
receive
#7
lifestyle changes such as low caloric diet like IF and exercise
increase
lipid metabolism and liver enzymes
-
-
can improve
#8
Abstract

INTRODUCTION: Non-alcoholic fatty liver disease (NAFLD) is a common liver disease characterized by an increase in fat in liver cells. The outbreak of NAFLD is estimated to be 32.4% worldwide, with higher rates in Asia and Iran. Nutritional factors such as excessive calorie intake, high fructose intake, copper deficiency, and increased iron intake play an important role in NAFLD. Since there is no specific treatment for NAFLD, intermittent fasting (IF) diet has been suggested as an alternative treatment for obesity and related complications. Previous studies showed the potential positive effects of IF on metabolic health and the reduction of oxidative stress in NAFLD. This randomized controlled trial (RCT) will be aimed to examine the effect of the IF diet in comparison with a low-calorie diet (LCD) on lipid profile, glycemic status, and liver fibrosis in patients with NAFLD. METHODS AND ANALYSIS: This is a parallel randomized clinical trial conducted on 52 overweight and obese patients with NAFLD. Participants will be randomly assigned to receive either 16:8 IF (fasting from 8 P.M. to 12 P.M. the next day) or a low-calorie (55% carbohydrate- 30% fat, 15% protein) diet for 12 weeks. Anthropometric measurements, liver assessments, and metabolic evaluations will be assessed before and after the intervention. Primary outcomes include liver steatosis and fibrosis, while secondary outcomes include liver function enzymes, insulin resistance, lipid profile, and anthropometric measurements. DISCUSSION: Since obesity and insulin resistance are the most important risk factors of NAFLD, and there is no treatment for it, it seems that lifestyle changes such as low caloric diet like IF and exercise can improve lipid metabolism and liver enzymes. TRIAL REGISTRATION: Iranian registry of clinical trials (IRCT20170202032367N5).

Study Links
Quality Scores
SafetyNot Assessed
Efficacy60/10
Quality70/10
Citation Metrics
Total Citations2
Citations/Year1.0
Relative Citation Ratio0.45
NIH Percentile24.4%
Research Impact Scores
APT Score0.50
Weight Score1.17
Normalized Score0.58
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