Maastricht University Medical Center
Maastricht, Limburg, Netherlands
NCT Number: NCT02245932
The primary objective is to investigate the efficacy of resveratrol on mitochondrial function in patients with COPD. The secondary objective is to investigate the effect of resveratrol on body composition, inflammatory status and mechanistic markers in blood, adipose and muscle tissue as well as a comprehensive assessment of metabolicand physical performance profile known to be affected by resveratrol.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Maastricht, Limburg, Netherlands
Rationale: Patients with COPD are often chaacterized by disturbed metabolic health affecting physical and cognitive function, which is reflected in altered body composition. current studies in healthy subjects suggest that resveratrol improves metabolic health by enhancing muscle mitochondrial function and adipose tissue morphology.
Study design: Proof-of-concept randomized placebo-controlled double blinded clinical trial of 4 weeks.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects may be confronted with certain inconveniences and risks. Subjects will be asked to wear an accelerometer two times for one week. During the entire study period subjects will visit the MUMC+ 2 times for various non-invasive measurements (questionnaires, anthropometry, and physical function test) as well as some minor invasive procedures (venous blood sampling and muscle and fat biopsies) which can cause a local haematoma afterwards. However, the patients will be informed about their metabolic and cardiovascular health, which we expect to be positively affected by the intervention. In addition, all patients will receive a lifestyle advice tailored to their health status.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
4 weeks of 150 mg resveratrol (2 times 75mg/day)
Other names: resVida (99% pure trans-resveratrol) provided by DSM Nutritional Products, Ltd.
4 weeks of placebo supplementation (two doses per day)
Time frame: 0 and 4 weeks
Assessed by measuring mitochondrial respiration (using the oxygraph) of a muscle biopsy of the quadriceps muscle (vastus lateralis)
Time frame: 0 and 4 weeks
High sensitivity C-reactive protein (CRP) as a clinical marker of systemic inflammation via blood sampling.
Time frame: 0 and 4 weeks
Assessed by adipose tissue biopsy
Time frame: 0 and 4 weeks
Assessed via blood sampling
Time frame: 0 and 4 weeks
Assessed via blood sampling
Time frame: 0 and 4 weeks
Assessed by HOMA-IR
Time frame: 0 and 4 weeks
Assessed by:
Time frame: 0 and 4weeks
Assessed by leg dynamometry (Biodex)
Time frame: 0 and 4 weeks
Measured with a hematometer
Time frame: 0 and 4 weeks
Measured with a hematometer
Time frame: 0 and 4 weeks
Medication use
Time frame: 0 and 4 weeks
Assessed by:
Time frame: 0 and 4 weeks
Assessed by:
Time frame: 0 and 4 weeks
Assess by Pittburgh Sleep Quality Index (PSQI)
Time frame: 0 and 4 weeks
Assessed by food anamnesis questionnaire
Time frame: 0 and 4 weeks
Assessed by blood sampling
Time frame: 0 and 4 weeks
Measured with a ECG
Time frame: 0 and 4 weeks
Assessed in blood:
Time frame: 0 weeks
Assessed by spirometry
Maastricht University Medical Center
Other
The Effect of Resveratrol on Metabolism and Cardiovascular Risk Profile in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Acronym: CARMENS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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