Liver BiomarkersNCT07891975
Modulatory Effects of Resveratrol Supplement Along With and Without Low Glycemic Index Diet Among Obese Patients With Diabetic Nephropathy
A study testing T0 starch capsule, T1 resveratrol capsule and T2 300 mg per day along with a low glycemic index diet, TWICE A DAY in people with Liver Biomarkers and Glucose, run by University of Lahore at 1 site in Pakistan.
Trial summary
This 12-week randomized controlled trial evaluated the effects of resveratrol supplementation with and without a low glycemic index (LGI) diet in obese patients with diabetic nephropathy. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Biomarkers, Glucose, Lipid Profiles
- What is being tested?
- T0 starch capsule, T1 resveratrol capsule and T2 300 mg per day along with a low glycemic index diet, TWICE A DAY
- 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
- 2 Jun 2025to 7 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Obese individuals - BMI ≥ 30.0 kg/m²
- Individuals with Fasting Plasma Glucose (FPG) ≤130 mg/dL
- Individuals with HbA1c ≤ 8% (≤64 mmol/mol).
- Urine albumin-creatinine ratio (UACR) ≥30 mg/g
- Serum creatinine ≤2 mg/dL.
- Blood urea nitrogen (BUN) ≤ 20 mg/dL
Show all 10Show fewer
- Estimated GFR (eGFR) ≥ 60 ml/min
- Inflammatory and stress biomarkers through TNF-α > 8.1 pg/mL and C-Reactive Protein (CRP) > 3 mg/L.
- Liver function test markers, ALT > 56 U/L, AST > 40 U/L, ALP > 147 U/L.
- Lipid profile levels, TC ≥ 200 mg/dL, TG ≥ 150 mg/dL, LDL ≥ 100 mg/dL, HDL ≤ 40 mg/dL.
Who cannot join
- Allergic to resveratrol.
- Liver failure (acute or chronic).
- Uncontrolled hypertension (BP ≥140/90 mmHg).
- Congestive heart failure.
- History of malignancy.
- Bilateral renal artery stenosis.
Show all 9Show fewer
- Any systemic disease other than diabetes.
- Active infection or rheumatological disorder.
- Use of warfarin or other anticoagulants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resveratrol Supplement Along With and Without Low Glycemic Index Diet Among Obese Patients With Diabetic Nephropathy
This 12-week randomized controlled trial evaluated the effects of resveratrol supplementation with and without a low glycemic index (LGI) diet in obese patients with diabetic nephropathy. Resveratrol, particularly at the higher dose combined with an LGI diet, significantly improved anthropometric, hepatic, renal, and biochemical parameters, including BMI, liver enzymes, BUN, UPCR, serum uric acid, phosphorus, and albumin levels. These findings suggest that resveratrol may serve as an effective nutraceutical adjunct to dietary modification for improving renal and metabolic health in diabetic nephropathy patients.
Read the detailed description
This randomized controlled trial investigated the modulatory effects of resveratrol supplementation, with and without a low glycemic index (LGI) diet, among 102 obese patients with diabetic nephropathy over a 12-week intervention period. Participants were randomly allocated into three groups, including a placebo group and two treatment groups receiving different doses of resveratrol. Clinical, anthropometric, and biochemical parameters were assessed at baseline and after the intervention to determine the efficacy of the treatments.
- Conditions
- Liver Biomarkers, Glucose, Lipid Profiles
- Being tested
- T0 starch capsule, T1 resveratrol capsule, T2 300 mg per day along with a low glycemic index diet, TWICE A DAY
- Keywords
- diabetic nephropathy, obesity, diabetes mellitus, renal diseases
- Medical subject headings
- Diabetic Nephropathies, Obesity, Diabetes Mellitus, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T0 starch capsuleDietary supplement
1 starch capsule of 300 mg along with their regular diet
T1 resveratrol capsuleDietary supplement
1 resveratrol capsule of 300 mg per day along with a low glycemic index diet, ONCE A DAY
T2 300 mg per day along with a low glycemic index diet, TWICE A DAYDietary supplement
1 resveratrol capsule of 300 mg per day along with a low glycemic index diet, TWICE A DAY
| Study group | Role | What they receive |
|---|---|---|
| PLACEBO T0 | Placebo comparator | 1 starch capsule of 300 mg along with their regular diet Receives: Dietary Supplement: T0 starch capsule |
| 1 resveratrol capsule of 300 mg per day T1 | Experimental | 1 resveratrol capsule of 300 mg per day along with a low glycemic index diet, once a day Receives: Dietary Supplement: T1 resveratrol capsule |
| 1 resveratrol capsules of 300 mg per day along with a low glycemic index diet, TWICE A DAY T2 | Experimental | 1 resveratrol capsules of 300 mg per day along with a low glycemic index diet, TWICE A DAY Receives: Dietary Supplement: T2 300 mg per day along with a low glycemic index diet, TWICE A DAY |
What is being measured
The primary outcome is the main question the study is designed to answer.
LIVER ENZYMES
liver enzymes were assessed (AST, ALT, ALP)
Measured: 12 WEEKS
LIPID PROFILE (TC,TG,LDL, HDL)
lipid profile assessed
Measured: 12 week
GLUCOSE (Fasting glucose)
fasting glucose assessed
Measured: 12 weeks
weight (kg)
weight
Measured: 12 weeks
Secondary outcomes (1)
INFLAMAMATION
inflammation was assessed through CRP
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 posted23 Oct 2026
- Study start2 Jun 2025
- Primary completion10 Aug 2025
- Study completion7 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.
- More trials run by University of LahoreThe sponsor's other registered studies.
- 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
- 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
- NCT07891975
- Sponsor's protocol ID
- UOL/IREB/25/13/0022
- Status last verified
- Jun 2025
- First submitted
- 28 Jun 2026
- Last updated
- 23 Oct 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 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resveratrol Supplement Along With and Without Low Glycemic Index Diet Among Obese Patients With Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT07891975
- Acronym / sponsor ID
- UOL/IREB/25/13/0022
- Conditions
- Liver Biomarkers, Glucose, Lipid Profiles
- Keywords
- diabetic nephropathy, obesity, diabetes mellitus, renal diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 10 Aug 2025 (actual)
- Study completion
- 7 Sep 2025 (actual)
- First posted
- 23 Oct 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 12-week randomized controlled trial evaluated the effects of resveratrol supplementation with and without a low glycemic index (LGI) diet in obese patients with diabetic nephropathy. Resveratrol, particularly at the higher dose combined with an LGI diet, significantly improved anthropometric, hepatic, renal, and biochemical parameters, including BMI, liver enzymes, BUN, UPCR, serum uric acid, phosphorus, and albumin levels. These findings suggest that resveratrol may serve as an effective nutraceutical adjunct to dietary modification for improving renal and metabolic health in diabetic nephropathy patients.
Detailed description
This randomized controlled trial investigated the modulatory effects of resveratrol supplementation, with and without a low glycemic index (LGI) diet, among 102 obese patients with diabetic nephropathy over a 12-week intervention period. Participants were randomly allocated into three groups, including a placebo group and two treatment groups receiving different doses of resveratrol. Clinical, anthropometric, and biochemical parameters were assessed at baseline and after the intervention to determine the efficacy of the treatments.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PLACEBO T0 | Placebo comparator | Dietary Supplement: T0 starch capsule1 starch capsule of 300 mg along with their regular diet |
| 1 resveratrol capsule of 300 mg per day T1 | Experimental | Dietary Supplement: T1 resveratrol capsule1 resveratrol capsule of 300 mg per day along with a low glycemic index diet, once a day |
| 1 resveratrol capsules of 300 mg per day along with a low glycemic index diet, TWICE A DAY T2 | Experimental | Dietary Supplement: T2 300 mg per day along with a low glycemic index diet, TWICE A DAY1 resveratrol capsules of 300 mg per day along with a low glycemic index diet, TWICE A DAY |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Obese individuals - BMI ≥ 30.0 kg/m²
- Individuals with Fasting Plasma Glucose (FPG) ≤130 mg/dL
- Individuals with HbA1c ≤ 8% (≤64 mmol/mol).
- Urine albumin-creatinine ratio (UACR) ≥30 mg/g
- Serum creatinine ≤2 mg/dL.
Key exclusion criteria (9 listed)
- Allergic to resveratrol.
- Liver failure (acute or chronic).
- Uncontrolled hypertension (BP ≥140/90 mmHg).
- Congestive heart failure.
- History of malignancy.
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 |
|---|---|---|
| T0 starch capsule1 starch capsule of 300 mg along with their regular diet | Dietary supplement | PLACEBO T0 |
| T1 resveratrol capsule1 resveratrol capsule of 300 mg per day along with a low glycemic index diet, ONCE A DAY | Dietary supplement | 1 resveratrol capsule of 300 mg per day T1 |
| T2 300 mg per day along with a low glycemic index diet, TWICE A DAY1 resveratrol capsule of 300 mg per day along with a low glycemic index diet, TWICE A DAY | Dietary supplement | 1 resveratrol capsules of 300 mg per day along with a low glycemic index diet, TWICE A DAY T2 |
Primary outcome
LIVER ENZYMES
Time frame: 12 WEEKS
liver enzymes were assessed (AST, ALT, ALP)
LIPID PROFILE (TC,TG,LDL, HDL)
Time frame: 12 week
lipid profile assessed
GLUCOSE (Fasting glucose)
Time frame: 12 weeks
fasting glucose assessed
weight (kg)
Time frame: 12 weeks
weight
1 secondary outcome
INFLAMAMATION
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 23 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Liver Biomarkers
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2/3
Tissue Analysis After Tumor Ablation for Liver Metastases Leading to Immediate Retreatment
Liver Metastases
Not yet recruitingObservational study
Immune-Related Adverse Events and Clinical Outcomes of First-Line Immunotherapy in Egyptian Patients With Unresectable Hepatocellular Carcinoma
Hepatocellular Carcinoma, Hepatocellular Carcinoma (HCC)
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
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 T0 starch capsule, T1 resveratrol capsule and T2 300 mg per day along with a low glycemic index diet, TWICE A DAY in people with Liver Biomarkers and Glucose, 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 10 inclusion and 9 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 23 Oct 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 WEEKS). The study lists 4 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 23 Oct 2026.