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 | Completed DMC

• 1 other identifier: uol123
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Biomarkers; Lipid Profile; Glucose; Insulin

Keywords

NAFLD; SUMAC; INSULIN RESISTANCE; INFLAMMMATION

Outcome Measures

Primary Outcomes (3)

• LIVER ENZYMES

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

  12 WEEK

• LIPID PROFILE

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

  12 weeks

• INSULIN RESISTANCE

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

  12-weeks

Secondary Outcomes (1)

• NFLAMMATION

  12 weeks

Study Arms (3)

T0

PLACEBO COMPARATOR

Participants received one placebo (starch) capsule daily along with their usual diet for 12 weeks

Dietary Supplement: Placebo (Starch Capsule)

T1

EXPERIMENTAL

T₁ received 1.5 g/day of Sumac supplementation with a calorie-restricted diet (1250-1300 kcal/day) for 12 weeks

Dietary Supplement: T1 SUMAC SUPPLEMENT

T2

EXPERIMENTAL

T₂ received 3.0 g/day of Sumac supplementation with the same calorie-restricted diet for 12 weeks.

Dietary Supplement: T2 SUMAC SUPPLEMENT

Interventions

T1 SUMAC SUPPLEMENT DIETARY_SUPPLEMENT

T₁ received 1.5 g/day of Sumac supplementation with a calorie-restricted diet (1250-1300 kcal/day)

T1

T2 SUMAC SUPPLEMENT DIETARY_SUPPLEMENT

T₂ received 3.0 g/day of Sumac supplementation with the same calorie-restricted diet for 12 weeks

T2

Placebo (Starch Capsule) DIETARY_SUPPLEMENT

One starch capsule administered daily for 12 weeks.

T0

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

Sana Noreen

Lahore, Punjab Province, 54000, Pakistan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Insulin Resistance; Non-alcoholic Fatty Liver Disease

Interventions

Starch

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: August 17, 2026
• Study Start: June 5, 2025
• Primary Completion: September 15, 2025
• Study Completion: September 16, 2025
• Last Updated: August 17, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)