Effects of Resveratrol Supplementation Combined With a Low-Calorie Diet in Postmenopausal Women With Obesity and Knee Osteoarthritis

NCT07634302 | Completed DMC

• 1 other identifier: 03022017N1
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is a major modifiable risk factor for knee osteoarthritis and is associated with chronic low-grade inflammation, pain, functional impairment, and cartilage degradation. Weight reduction is recommended as a core component of osteoarthritis management, while resveratrol has demonstrated anti-inflammatory and chondroprotective properties in experimental and clinical studies. However, the potential additional benefit of resveratrol supplementation when combined with dietary intervention remains uncertain. This randomized controlled trial evaluated the effects of 150 mg/day trans-resveratrol supplementation as an adjunct to a low-calorie diet in postmenopausal women with obesity and knee osteoarthritis. Ninety-seven participants were randomized to receive either a low-calorie diet alone or the same diet combined with resveratrol for 10 days. Outcomes included pain intensity, functional status, urinary C-terminal telopeptide of type II collagen (CTX-II), anthropometric parameters, body composition, metabolic markers, lipid profile, and inflammatory biomarkers.

Conditions

Obesity (Disorder); Knee Osteoarthritis (Knee OA)

Keywords

Resveratrol; Obesity; Knee Osteoarthritis; Postmenopausal Women; Low-Calorie Diet; Inflammation

Outcome Measures

Primary Outcomes (4)

• Urinary CTX-II

  Change in urinary C-terminal telopeptide of type II collagen concentration corrected for urinary creatinine.

  Baseline and Day 10

• WOMAC Score

  Change in Western Ontario and McMaster Universities Osteoarthritis Index total score.

  Baseline and Day 10

• Pain Intensity (VAS)

  Change in pain intensity measured by Visual Analog Scale.

  Baseline and Day 10

• hsCRP

  high-sensitivity C-reactive protein; measured in mg/L

  Baseline and Day 10

Secondary Outcomes (8)

• Body weight

  Baseline and Day 10

• BMI

  Baseline and Day 10

• Fat mass

  Baseline and Day 10

• HOMA-IR

  Baseline and Day 10

• Total cholesterol

  Baseline and Day 10

Study Arms (2)

Low-Calorie Diet

ACTIVE COMPARATOR

Participants received a standardized low-calorie diet providing approximately 1700 kcal/day for 10 consecutive days during inpatient treatment. The diet included moderate energy restriction through reduced fat and carbohydrate intake, exclusion of added sugars, restriction of animal fats and sodium, and inclusion of dietary fiber sources such as vegetables, fruits, and cereals.

Behavioral: Low-Calorie Diet

Low-Calorie Diet Plus Resveratrol

EXPERIMENTAL

Participants received the same standardized low-calorie diet as the control group and additionally received trans-resveratrol supplementation at a dose of 150 mg/day for 10 consecutive days during inpatient treatment.

Dietary Supplement: Trans-resveratrol extract from Polygonum Cuspidatum

Interventions

Trans-resveratrol extract from Polygonum Cuspidatum DIETARY_SUPPLEMENT

Participants received 150 mg/day of trans-resveratrol (\>99% purity) administered once daily with a meal for 10 days in addition to a standardized low-calorie diet.

Low-Calorie Diet Plus Resveratrol

Low-Calorie Diet BEHAVIORAL

A standardized low-calorie diet providing approximately 1700 kcal/day for 10 days. The diet was designed to achieve moderate energy restriction and was administered under inpatient supervision.

Low-Calorie Diet

Eligibility Criteria

• Age: 45 Years - 75 Years
• Gender Eligibility Details: The study included postmenopausal obese women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women aged 45-75 years.
• Diagnosed knee osteoarthritis.
• Obesity, defined as BMI ≥30 kg/m².
• Ability to comply with the study protocol and dietary recommendations.
• Written informed consent to participate in the study.

You may not qualify if:

• Allergy or intolerance to grapes, wine, peanuts, resveratrol, or supplement components.
• Acute infectious or inflammatory disease at screening.
• Unstable or exacerbated chronic disease requiring treatment changes or hospitalization.
• Malignancy within the past 5 years.
• Chronic liver disease, including hepatitis or cirrhosis.
• Major cardiovascular event within the past 6 months.
• Alcohol abuse or dependence.
• Severe psychiatric disorder or cognitive impairment limiting protocol adherence.
• Use of resveratrol-containing supplements or investigational products within the past 6 months.

Sponsors & Collaborators

• Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology: lead

Study Sites (1)

Department of Cardiovascular Pathology and Diet Therapy

Moscow, 115446, Russia

Location

MeSH Terms

Conditions

Obesity; Osteoarthritis, Knee; Inflammation

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 8, 2026
• Study Start: March 20, 2017
• Primary Completion: July 13, 2018
• Study Completion: September 10, 2018
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

RU (1)