- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07634302
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.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Moscow, Rosja, 115446
- Department of Cardiovascular Pathology and Diet Therapy
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: 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.
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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.
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Eksperymentalny: 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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Urinary CTX-II
Ramy czasowe: Baseline and Day 10
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Change in urinary C-terminal telopeptide of type II collagen concentration corrected for urinary creatinine.
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Baseline and Day 10
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WOMAC Score
Ramy czasowe: Baseline and Day 10
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Change in Western Ontario and McMaster Universities Osteoarthritis Index total score.
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Baseline and Day 10
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Pain Intensity (VAS)
Ramy czasowe: Baseline and Day 10
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Change in pain intensity measured by Visual Analog Scale.
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Baseline and Day 10
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hsCRP
Ramy czasowe: Baseline and Day 10
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high-sensitivity C-reactive protein; measured in mg/L
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Baseline and Day 10
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Body weight
Ramy czasowe: Baseline and Day 10
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Change from baseline in body weight (kg)
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Baseline and Day 10
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BMI
Ramy czasowe: Baseline and Day 10
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Body Mass Index; calculated as weight in kg divided by height in meters squared
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Baseline and Day 10
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Fat mass
Ramy czasowe: Baseline and Day 10
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measured in kg or % of total body mass; bioelectrical impedance analysis
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Baseline and Day 10
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HOMA-IR
Ramy czasowe: Baseline and Day 10
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Homeostatic Model Assessment for Insulin Resistance; calculated as fasting insulin (μU/mL) × fasting glucose (mmol/L) / 22.5
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Baseline and Day 10
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Total cholesterol
Ramy czasowe: Baseline and Day 10
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Total cholesterol (measured in mg/dL or mmol/L)
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Baseline and Day 10
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LDL-C
Ramy czasowe: Baseline and Day 10
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LDL-C (low-density lipoprotein cholesterol; measured in mg/dL or mmol/L)
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Baseline and Day 10
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HDL-C
Ramy czasowe: Baseline and Day 10
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HDL-C (high-density lipoprotein cholesterol; measured in mg/dL or mmol/L)
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Baseline and Day 10
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Triglycerides
Ramy czasowe: Baseline and Day 10
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Triglycerides (measured in mg/dL or mmol/L)
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Baseline and Day 10
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Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby układu mięśniowo-szkieletowego
- Procesy patologiczne
- Zaburzenia odżywiania
- Artretyzm
- Choroby stawów
- Choroby reumatyczne
- Przekarmienie
- Masy ciała
- Zapalenie kości i stawów
- Nadwaga
- Stany patologiczne, oznaki i objawy
- Choroby żywieniowe i metaboliczne
- Objawy i symptomy
- Otyłość
- Choroba zwyrodnieniowa stawów, kolano
- Zapalenie
- Lecznictwo
- Dieta, żywność i odżywianie
- Zjawiska fizjologiczne
- Zjawiska fizjologiczne żywieniowe
- Terapia dietetyczna
- Terapia żywieniowa
- Dieta
- Spożycie energii
- Ograniczenie kaloryczne
Inne numery identyfikacyjne badania
- 03022017N1
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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