Improvement in Hepatic Function Through Sumac (Rhus Coriaria L.) Supplement Along With a Calorie-restricted Diet for the Management of Grade-I Obese Non-alcoholic Fatty Liver Disease Patients

University of Lahore102 enrolled

Overview

This randomized controlled trial aims to evaluate the effects of Rhus coriaria L. (Sumac) supplementation combined with a calorie-restricted diet on hepatic function and metabolic health in grade-I obese patients with non-alcoholic fatty liver disease (NAFLD). A total of 102 participants aged 30-60 years with confirmed NAFLD will be randomly assigned to one of three groups: placebo, 1.5 g/day Sumac supplementation, or 3.0 g/day Sumac supplementation for 12 weeks. Outcomes will include changes in liver function tests (ALT, AST, and ALP), anthropometric measurements, glycemic control, insulin resistance, lipid profile, and inflammatory biomarkers. The study aims to determine whether Sumac supplementation provides additional benefits beyond calorie restriction alone in improving hepatic health and metabolic risk factors associated with NAFLD.

This randomized, placebo-controlled clinical trial is designed to investigate the efficacy of Rhus coriaria L. (Sumac) supplementation in combination with a calorie-restricted diet for improving hepatic function and metabolic health in grade-I obese patients with non-alcoholic fatty liver disease (NAFLD). NAFLD is a growing public health concern characterized by excessive fat accumulation in the liver and is commonly associated with obesity, insulin resistance, dyslipidemia, and chronic low-grade inflammation. A total of 102 eligible participants aged 30-60 years with confirmed NAFLD will be randomly assigned to one of three parallel groups for a 12-week intervention period: a placebo group receiving starch capsules with their usual diet, an intervention group receiving 1.5 g/day of Sumac supplementation combined with a calorie-restricted diet (1250-1300 kcal/day), and an intervention group receiving 3.0 g/day of Sumac supplementation combined with the same dietary regimen. The calorie-restricted diet is designed to promote gradual weight reduction and improve metabolic outcomes. Primary outcomes include changes in liver function parameters, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP). Secondary outcomes include changes in body weight, body mass index (BMI), fasting blood glucose (FBG), glycated hemoglobin (HbA1c), serum insulin, Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), lipid profile (total cholesterol, triglycerides, LDL, and HDL cholesterol), and inflammatory biomarkers such as C-reactive protein (CRP) and tumor necrosis factor-alpha (TNF-α).

Study Type

INTERVENTIONAL

Eligibility

Sex: ALLMin age: 30 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * subjects were required to be obese adults aged 30 to 60 years with a Body Mass Index (BMI) of 30 kg/m2 * confirmed diagnosis of Non-Alcoholic Fatty Liver Disease (NAFLD) via abdominal ultrasonography. * Biochemically, participants met the criteria for elevated liver enzymes, defined as alanine aminotransferase (ALT) \> 56 U/L, aspartate aminotransferase (AST) \> 40 U/L, or alkaline phosphatase (ALP) \> 147 U/L. * They also exhibited impaired glycemic status with a fasting blood sugar (FBS) \> 130 mg/dL and a glycated hemoglobin (HbA1c) level between 6.0% and 8.0%, . * dyslipidemia characterized by total cholesterol \>200 mg/dL, triglycerides \>150 mg/dL low-density lipoprotein (LDL) \>100 mg/dL, or high-density lipoprotein (HDL) \< 40 mg/dL. * Finally, all selected individuals demonstrated a documented willingness to participate in a supervised, calorie-restricted dietary intervention. Exclusion Criteria: * individuals were excluded from the study if they presented with secondary causes of hepatic steatosis, including significant alcohol consumption, chronic viral hepatitis (B or C), * autoimmune hepatitis, or drug-induced liver injury. * Potential participants were also excluded if they had a history of advanced liver disease (cirrhosis or hepatocellular carcinoma), * severe renal or cardiovascular comorbidities, or were currently taking medications known to induce steatosis (such as systemic corticosteroids or amiodarone). .Pregnant or lactating women were likewise excluded from enrollment.

Outcomes

Primary Outcomes

LIVER ENZYMES

Liver enzymes (AST,ALP, ALT) assesed on zero day and on 12 week

Time frame: 12 WEEK

LIPID PROFILE

lipid profile assesed on zero day and on 12 week of the study

Time frame: 12 weeks

INSULIN RESISTANCE

insulin resisitance checked on zero day and on 12 week of the study

Time frame: 12-weeks

Secondary Outcomes

NFLAMMATION

through CRP inflammation assessed on 12 week of the study