Obesity (Disorder)ERSOKONCT07634302
Effects of Resveratrol Supplementation Combined With a Low-Calorie Diet in Postmenopausal Women With Obesity and Knee Osteoarthritis
A study testing Trans-resveratrol extract from Polygonum Cuspidatum and Low-Calorie Diet in people with Obesity (Disorder) and Knee Osteoarthritis (Knee OA), run by Federal State Budgetary Scientific Institution at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Obesity (Disorder), Knee Osteoarthritis (Knee OA)
- What is being tested?
- Trans-resveratrol extract from Polygonum Cuspidatum and Low-Calorie Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteRussia
- Study dates
- 20 Mar 2017to 10 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Department of Cardiovascular Pathology and Diet Therapy
Moscow, 115446
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Obesity (Disorder), Knee Osteoarthritis (Knee OA)
- Being tested
- Trans-resveratrol extract from Polygonum Cuspidatum, Low-Calorie Diet
- Keywords
- Resveratrol, Obesity, Knee Osteoarthritis, Postmenopausal Women, Low-Calorie Diet, Inflammation
- Medical subject headings
- Obesity, Osteoarthritis, Knee, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-resveratrol extract from Polygonum CuspidatumDietary 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 DietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Trans-resveratrol extract from Polygonum Cuspidatum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary CTX-II
Change in urinary C-terminal telopeptide of type II collagen concentration corrected for urinary creatinine.
Measured: Baseline and Day 10
WOMAC Score
Change in Western Ontario and McMaster Universities Osteoarthritis Index total score.
Measured: Baseline and Day 10
Pain Intensity (VAS)
Change in pain intensity measured by Visual Analog Scale.
Measured: Baseline and Day 10
hsCRP
high-sensitivity C-reactive protein; measured in mg/L
Measured: Baseline and Day 10
Secondary outcomes (8)
Body weight
Change from baseline in body weight (kg)
Measured: Baseline and Day 10
BMI
Body Mass Index; calculated as weight in kg divided by height in meters squared
Measured: Baseline and Day 10
Fat mass
measured in kg or % of total body mass; bioelectrical impedance analysis
Measured: Baseline and Day 10
HOMA-IR
Homeostatic Model Assessment for Insulin Resistance; calculated as fasting insulin (μU/mL) × fasting glucose (mmol/L) / 22.5
Measured: Baseline and Day 10
Total cholesterol
Total cholesterol (measured in mg/dL or mmol/L)
Measured: Baseline and Day 10
LDL-C
LDL-C (low-density lipoprotein cholesterol; measured in mg/dL or mmol/L)
Measured: Baseline and Day 10
HDL-C
HDL-C (high-density lipoprotein cholesterol; measured in mg/dL or mmol/L)
Measured: Baseline and Day 10
Triglycerides
Triglycerides (measured in mg/dL or mmol/L)
Measured: Baseline and Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start20 Mar 2017
- Primary completion13 Jul 2018
- Study completion10 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Scientific Institution
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yurgita R. Varaeva, MD, MRes, Federal State Budgetary Scientific Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634302
- Sponsor's protocol ID
- 03022017N1
- Acronym
- ERSOKO
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resveratrol as an Adjunct to a Low-Calorie Diet in Postmenopausal Women With Obesity and Knee Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07634302
- Acronym / sponsor ID
- ERSOKO / 03022017N1
- Conditions
- Obesity (Disorder), Knee Osteoarthritis (Knee OA)
- Keywords
- Resveratrol, Obesity, Knee Osteoarthritis, Postmenopausal Women, Low-Calorie Diet, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Federal State Budgetary Scientific InstitutionOther government
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 13 Jul 2018 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Calorie Diet | Active comparator | Behavioral: Low-Calorie DietParticipants 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. |
| Low-Calorie Diet Plus Resveratrol | Experimental | Dietary Supplement: Trans-resveratrol extract from Polygonum CuspidatumParticipants 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans-resveratrol extract from Polygonum CuspidatumParticipants 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. | Dietary supplement | Low-Calorie Diet Plus Resveratrol |
| Low-Calorie DietA 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. | Behavioural | Low-Calorie Diet |
Primary outcome
Urinary CTX-II
Time frame: Baseline and Day 10
Change in urinary C-terminal telopeptide of type II collagen concentration corrected for urinary creatinine.
WOMAC Score
Time frame: Baseline and Day 10
Change in Western Ontario and McMaster Universities Osteoarthritis Index total score.
Pain Intensity (VAS)
Time frame: Baseline and Day 10
Change in pain intensity measured by Visual Analog Scale.
hsCRP
Time frame: Baseline and Day 10
high-sensitivity C-reactive protein; measured in mg/L
8 secondary outcomes
Body weight
Time frame: Baseline and Day 10
BMI
Time frame: Baseline and Day 10
Fat mass
Time frame: Baseline and Day 10
HOMA-IR
Time frame: Baseline and Day 10
Total cholesterol
Time frame: Baseline and Day 10
LDL-C
Time frame: Baseline and Day 10
HDL-C
Time frame: Baseline and Day 10
Triglycerides
Time frame: Baseline and Day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Obesity (Disorder)
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-resveratrol extract from Polygonum Cuspidatum and Low-Calorie Diet in people with Obesity (Disorder) and Knee Osteoarthritis (Knee OA), run by Federal State Budgetary Scientific Institution at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary CTX-II (time frame: Baseline and Day 10). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.