Glucose, Insulin, Lipid Profile, Liver Biomarkers
Conditions
Keywords
NAFLD, SUMAC, INSULIN RESISTANCE, INFLAMMMATION
Brief summary
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.
Detailed description
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).
Interventions
DIETARY_SUPPLEMENTT1 SUMAC SUPPLEMENT
T₁ received 1.5 g/day of Sumac supplementation with a calorie-restricted diet (1250-1300 kcal/day)
DIETARY_SUPPLEMENTT2 SUMAC SUPPLEMENT
T₂ received 3.0 g/day of Sumac supplementation with the same calorie-restricted diet for 12 weeks
DIETARY_SUPPLEMENTPlacebo (Starch Capsule)
One starch capsule administered daily for 12 weeks.
Sponsors
University of Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Intervention model description
Participants were randomized to receive either a placebo with a regular diet (T₀), 1.5 g/day Sumac plus a calorie-restricted diet (T₁), or 3.0 g/day Sumac plus a calorie-restricted diet (T₂) for 12 weeks.
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LIVER ENZYMES | 12 WEEK | Liver enzymes (AST,ALP, ALT) assesed on zero day and on 12 week |
| LIPID PROFILE | 12 weeks | lipid profile assesed on zero day and on 12 week of the study |
| INSULIN RESISTANCE | 12-weeks | insulin resisitance checked on zero day and on 12 week of the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NFLAMMATION | 12 weeks | through CRP inflammation assessed on 12 week of the study |
Countries
Pakistan
Outcome results
None listed