NCT07891975

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
Last Updated

October 23, 2026

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

June 28, 2026

Last Update Submit

October 16, 2026

Conditions

Liver BiomarkersGlucoseLipid Profiles

Keywords

diabetic nephropathyobesitydiabetes mellitusrenal diseases

Outcome Measures

Primary Outcomes (4)

  • LIVER ENZYMES

    liver enzymes were assessed (AST, ALT, ALP)

    12 WEEKS

  • LIPID PROFILE (TC,TG,LDL, HDL)

    lipid profile assessed

    12 week

  • GLUCOSE (Fasting glucose)

    fasting glucose assessed

    12 weeks

  • weight (kg)

    weight

    12 weeks

Secondary Outcomes (1)

  • INFLAMAMATION

    12 WEEKS

Study Arms (3)

PLACEBO T0

PLACEBO COMPARATOR

1 starch capsule of 300 mg along with their regular diet

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

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

Dietary Supplement: T2 300 mg per day along with a low glycemic index diet, TWICE A DAY

Interventions

T0 starch capsuleDIETARY_SUPPLEMENT

1 starch capsule of 300 mg along with their regular diet

PLACEBO T0
T1 resveratrol capsuleDIETARY_SUPPLEMENT

1 resveratrol capsule of 300 mg per day along with a low glycemic index diet, ONCE A DAY

1 resveratrol capsule of 300 mg per day T1
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

1 resveratrol capsules of 300 mg per day along with a low glycemic index diet, TWICE A DAY T2

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • Allergic to resveratrol.
  • Liver failure (acute or chronic).
  • Uncontrolled hypertension (BP ≥140/90 mmHg).
  • Congestive heart failure.
  • History of malignancy.
  • Bilateral renal artery stenosis.
  • Any systemic disease other than diabetes.
  • Active infection or rheumatological disorder.
  • Use of warfarin or other anticoagulants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sana Noreen

Lahore, Punjab Province, 54000, Pakistan

Location

Related Links

MeSH Terms

Conditions

Diabetic NephropathiesObesityDiabetes MellitusKidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsEndocrine System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic Diseases

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

Study Record Dates

First Submitted

June 28, 2026

First Posted

October 23, 2026

Study Start

June 2, 2025

Primary Completion

August 10, 2025

Study Completion

September 7, 2025

Last Updated

October 23, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)