Liver BiomarkersNCT07768657
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
A study testing T1 SUMAC SUPPLEMENT and T2 SUMAC SUPPLEMENT in people with Liver Biomarkers and Lipid Profile, run by University of Lahore at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Biomarkers, Lipid Profile, Glucose
- What is being tested?
- T1 SUMAC SUPPLEMENT and T2 SUMAC SUPPLEMENT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jun 2025to 16 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hepatic Function Through Sumac (Rhus Coriaria L.) Supplement Along With a Calorie-restricted Diet
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.
Read the 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).
- Conditions
- Liver Biomarkers, Lipid Profile, Glucose, Insulin
- Being tested
- T1 SUMAC SUPPLEMENT, T2 SUMAC SUPPLEMENT, Placebo (Starch Capsule)
- Keywords
- NAFLD, SUMAC, INSULIN RESISTANCE, INFLAMMMATION
- Medical subject headings
- Insulin Resistance, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T1 SUMAC SUPPLEMENTDietary supplement
T₁ received 1.5 g/day of Sumac supplementation with a calorie-restricted diet (1250-1300 kcal/day)
T2 SUMAC SUPPLEMENTDietary supplement
T₂ received 3.0 g/day of Sumac supplementation with the same calorie-restricted diet for 12 weeks
Placebo (Starch Capsule)Dietary supplement
One starch capsule administered daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| T0 | Placebo comparator | Participants received one placebo (starch) capsule daily along with their usual diet for 12 weeks Receives: 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 Receives: 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. Receives: Dietary Supplement: T2 SUMAC SUPPLEMENT |
What is being measured
The primary outcome is the main question the study is designed to answer.
LIVER ENZYMES
Liver enzymes (AST,ALP, ALT) assesed on zero day and on 12 week
Measured: 12 WEEK
LIPID PROFILE
lipid profile assesed on zero day and on 12 week of the study
Measured: 12 weeks
INSULIN RESISTANCE
insulin resisitance checked on zero day and on 12 week of the study
Measured: 12-weeks
Secondary outcomes (1)
NFLAMMATION
through CRP inflammation assessed on 12 week of the study
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start5 Jun 2025
- Primary completion15 Sep 2025
- Study completion16 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver BiomarkersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768657
- Sponsor's protocol ID
- uol123
- Status last verified
- Jun 2025
- First submitted
- 28 Jun 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Function Through Sumac (Rhus Coriaria L.) Supplement Along With a Calorie-restricted Diet
- ClinicalTrials.gov ID
- NCT07768657
- Acronym / sponsor ID
- uol123
- Conditions
- Liver Biomarkers, Lipid Profile, Glucose, Insulin
- Keywords
- NAFLD, SUMAC, INSULIN RESISTANCE, INFLAMMMATION
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 16 Sep 2025 (actual)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| T0 | Placebo comparator | Dietary Supplement: Placebo (Starch Capsule)Participants received one placebo (starch) capsule daily along with their usual diet for 12 weeks |
| T1 | Experimental | Dietary Supplement: T1 SUMAC SUPPLEMENTT₁ received 1.5 g/day of Sumac supplementation with a calorie-restricted diet (1250-1300 kcal/day) for 12 weeks |
| T2 | Experimental | Dietary Supplement: T2 SUMAC SUPPLEMENTT₂ received 3.0 g/day of Sumac supplementation with the same calorie-restricted diet for 12 weeks. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T1 SUMAC SUPPLEMENTT₁ received 1.5 g/day of Sumac supplementation with a calorie-restricted diet (1250-1300 kcal/day) | Dietary supplement | T1 |
| T2 SUMAC SUPPLEMENTT₂ received 3.0 g/day of Sumac supplementation with the same calorie-restricted diet for 12 weeks | Dietary supplement | T2 |
| Placebo (Starch Capsule)One starch capsule administered daily for 12 weeks. | Dietary supplement | T0 |
Primary outcome
LIVER ENZYMES
Time frame: 12 WEEK
Liver enzymes (AST,ALP, ALT) assesed on zero day and on 12 week
LIPID PROFILE
Time frame: 12 weeks
lipid profile assesed on zero day and on 12 week of the study
INSULIN RESISTANCE
Time frame: 12-weeks
insulin resisitance checked on zero day and on 12 week of the study
1 secondary outcome
NFLAMMATION
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T1 SUMAC SUPPLEMENT and T2 SUMAC SUPPLEMENT in people with Liver Biomarkers and Lipid Profile, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LIVER ENZYMES (time frame: 12 WEEK). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.