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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

NCT07768657

CompletedNA

Sponsor: University of Lahore

Conditions: Liver Biomarkers, Lipid Profile, Glucose, Insulin

Interventions: T1 SUMAC SUPPLEMENT, T2 SUMAC SUPPLEMENT, Placebo (Starch Capsule)

Countries: Pakistan

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.

Eligibility overview

Sex: ALL

Age: 30 Years to 60 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Lahore, Punjab Province, Pakistan