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

Effects of Resveratrol as an Adjunct to a Low-Calorie Diet in Postmenopausal Women With Obesity and Knee Osteoarthritis: A Randomized Controlled Trial

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.

Panoramica dello studio

Descrizione dettagliata

Obesity is a major modifiable risk factor for knee osteoarthritis and contributes not only to increased mechanical loading of the joints but also to chronic low-grade systemic inflammation, metabolic dysfunction, and cartilage degradation. Postmenopausal women represent a particularly vulnerable population because obesity and menopause-related hormonal changes may accelerate the development and progression of osteoarthritis. Current clinical guidelines recommend weight management as a core component of osteoarthritis treatment, particularly in patients with obesity.

Resveratrol is a naturally occurring polyphenolic compound found in grapes, berries, peanuts, and other plants. Experimental studies have demonstrated anti-inflammatory, antioxidant, and chondroprotective properties of resveratrol. Potential mechanisms include modulation of inflammatory signaling pathways, reduction of oxidative stress, inhibition of cartilage matrix degradation, and protection of chondrocyte viability. Although several clinical studies have investigated the effects of resveratrol in metabolic disorders and osteoarthritis, its efficacy as an adjunct to dietary intervention remains insufficiently characterized.

The purpose of this randomized controlled trial was to evaluate whether supplementation with trans-resveratrol provides additional clinical and metabolic benefits when combined with a low-calorie diet in postmenopausal women with obesity and knee osteoarthritis.

Eligible participants were postmenopausal women with obesity (body mass index ≥30 kg/m²) and radiographically confirmed knee osteoarthritis of Kellgren-Lawrence grade II or III. Participants were recruited during inpatient treatment at the Nutrition Clinic of the Federal Research Centre of Nutrition, Biotechnology and Food Safety. After baseline assessment, participants were randomized in a 1:1 ratio to receive either a low-calorie diet alone or the same low-calorie diet combined with trans-resveratrol supplementation.

All participants received a standardized low-calorie diet providing approximately 1700 kcal per day for 10 consecutive days. The diet was based on moderate energy restriction with reduced fat and carbohydrate intake and exclusion of added sugars. Participants assigned to the intervention group additionally received 150 mg/day of trans-resveratrol throughout the intervention period.

Assessments were performed at baseline and at the end of the intervention period. Clinical outcomes included pain intensity measured by the Visual Analog Scale (VAS), functional status assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Lequesne Algofunctional Index (LAI). Anthropometric measurements included body weight, body mass index, waist circumference, and hip circumference. Body composition was evaluated using multifrequency bioelectrical impedance analysis. Laboratory assessments included markers of carbohydrate metabolism, lipid metabolism, systemic inflammation, and routine biochemical parameters. Cartilage degradation was evaluated by measurement of urinary C-terminal telopeptide of type II collagen (CTX-II).

The primary objective of the study was to evaluate the effect of resveratrol supplementation on osteoarthritis-related outcomes and cartilage degradation markers when added to a low-calorie diet. Secondary objectives included assessment of changes in anthropometric parameters, body composition, metabolic indicators, lipid profile, and systemic inflammation.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

97

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Moscow, Russia, 115446
        • Department of Cardiovascular Pathology and Diet Therapy

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Low-Calorie Diet
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.
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.
Sperimentale: Low-Calorie Diet Plus Resveratrol
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.
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Urinary CTX-II
Lasso di tempo: Baseline and Day 10
Change in urinary C-terminal telopeptide of type II collagen concentration corrected for urinary creatinine.
Baseline and Day 10
WOMAC Score
Lasso di tempo: Baseline and Day 10
Change in Western Ontario and McMaster Universities Osteoarthritis Index total score.
Baseline and Day 10
Pain Intensity (VAS)
Lasso di tempo: Baseline and Day 10
Change in pain intensity measured by Visual Analog Scale.
Baseline and Day 10
hsCRP
Lasso di tempo: Baseline and Day 10
high-sensitivity C-reactive protein; measured in mg/L
Baseline and Day 10

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Body weight
Lasso di tempo: Baseline and Day 10
Change from baseline in body weight (kg)
Baseline and Day 10
BMI
Lasso di tempo: Baseline and Day 10
Body Mass Index; calculated as weight in kg divided by height in meters squared
Baseline and Day 10
Fat mass
Lasso di tempo: Baseline and Day 10
measured in kg or % of total body mass; bioelectrical impedance analysis
Baseline and Day 10
HOMA-IR
Lasso di tempo: Baseline and Day 10
Homeostatic Model Assessment for Insulin Resistance; calculated as fasting insulin (μU/mL) × fasting glucose (mmol/L) / 22.5
Baseline and Day 10
Total cholesterol
Lasso di tempo: Baseline and Day 10
Total cholesterol (measured in mg/dL or mmol/L)
Baseline and Day 10
LDL-C
Lasso di tempo: Baseline and Day 10
LDL-C (low-density lipoprotein cholesterol; measured in mg/dL or mmol/L)
Baseline and Day 10
HDL-C
Lasso di tempo: Baseline and Day 10
HDL-C (high-density lipoprotein cholesterol; measured in mg/dL or mmol/L)
Baseline and Day 10
Triglycerides
Lasso di tempo: Baseline and Day 10
Triglycerides (measured in mg/dL or mmol/L)
Baseline and Day 10

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 marzo 2017

Completamento primario (Effettivo)

13 luglio 2018

Completamento dello studio (Effettivo)

10 settembre 2018

Date di iscrizione allo studio

Primo inviato

3 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 giugno 2026

Primo Inserito (Effettivo)

8 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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