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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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

97

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Moscow、俄罗斯、115446
        • Department of Cardiovascular Pathology and Diet Therapy

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器: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.
实验性的: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Urinary CTX-II
大体时间: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
大体时间:Baseline and Day 10
Change in Western Ontario and McMaster Universities Osteoarthritis Index total score.
Baseline and Day 10
Pain Intensity (VAS)
大体时间:Baseline and Day 10
Change in pain intensity measured by Visual Analog Scale.
Baseline and Day 10
hsCRP
大体时间:Baseline and Day 10
high-sensitivity C-reactive protein; measured in mg/L
Baseline and Day 10

次要结果测量

结果测量
措施说明
大体时间
Body weight
大体时间:Baseline and Day 10
Change from baseline in body weight (kg)
Baseline and Day 10
BMI
大体时间:Baseline and Day 10
Body Mass Index; calculated as weight in kg divided by height in meters squared
Baseline and Day 10
Fat mass
大体时间:Baseline and Day 10
measured in kg or % of total body mass; bioelectrical impedance analysis
Baseline and Day 10
HOMA-IR
大体时间: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
大体时间:Baseline and Day 10
Total cholesterol (measured in mg/dL or mmol/L)
Baseline and Day 10
LDL-C
大体时间:Baseline and Day 10
LDL-C (low-density lipoprotein cholesterol; measured in mg/dL or mmol/L)
Baseline and Day 10
HDL-C
大体时间:Baseline and Day 10
HDL-C (high-density lipoprotein cholesterol; measured in mg/dL or mmol/L)
Baseline and Day 10
Triglycerides
大体时间:Baseline and Day 10
Triglycerides (measured in mg/dL or mmol/L)
Baseline and Day 10

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年3月20日

初级完成 (实际的)

2018年7月13日

研究完成 (实际的)

2018年9月10日

研究注册日期

首次提交

2026年6月3日

首先提交符合 QC 标准的

2026年6月3日

首次发布 (实际的)

2026年6月8日

研究记录更新

最后更新发布 (实际的)

2026年6月8日

上次提交的符合 QC 标准的更新

2026年6月3日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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