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| ID | Type | Description | Link |
|---|---|---|---|
| 3.4.12.023 | Other Grant/Funding Number | The Netherlands Lung Foundation |
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| Name | Class |
|---|---|
| The Netherlands Asthma Foundation | OTHER |
| dsm-firmenich Switzerland AG | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resveratrol supplementation | Experimental | 150 mg of resveratrol for 4 weeks (split over two doses of 75 mg/day) |
|
| Placebo supplementation | Placebo Comparator | Placebo for 4 weeks (split over two doses per day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resveratrol | Dietary Supplement | 4 weeks of 150 mg resveratrol (2 times 75mg/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in mitochondrial function | Assessed by measuring mitochondrial respiration (using the oxygraph) of a muscle biopsy of the quadriceps muscle (vastus lateralis) | 0 and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in high sensitivity systemic inflammation (CRP) at 4 weeks | High sensitivity C-reactive protein (CRP) as a clinical marker of systemic inflammation via blood sampling. | 0 and 4 weeks |
| Change in adipose tissue inflammation |
| Measure | Description | Time Frame |
|---|---|---|
| Medical history | Medication use | 0 and 4 weeks |
| Physical activity | Assessed by:
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annemie Schols, Prof. | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Limburg | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22055504 | Background | Timmers S, Konings E, Bilet L, Houtkooper RH, van de Weijer T, Goossens GH, Hoeks J, van der Krieken S, Ryu D, Kersten S, Moonen-Kornips E, Hesselink MKC, Kunz I, Schrauwen-Hinderling VB, Blaak E, Auwerx J, Schrauwen P. Calorie restriction-like effects of 30 days of resveratrol supplementation on energy metabolism and metabolic profile in obese humans. Cell Metab. 2011 Nov 2;14(5):612-22. doi: 10.1016/j.cmet.2011.10.002. | |
| 23281350 |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| D036881 | Long-Term Synaptic Depression |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| Placebo | Dietary Supplement | 4 weeks of placebo supplementation (two doses per day) |
|
Assessed by adipose tissue biopsy
| 0 and 4 weeks |
| Change in systematic inflammatory profile | Assessed via blood sampling | 0 and 4 weeks |
| Change in lipid profile | Assessed via blood sampling | 0 and 4 weeks |
| Change in insulin sensitivity | Assessed by HOMA-IR | 0 and 4 weeks |
| Change in body composition | Assessed by:
| 0 and 4 weeks |
| Change in quadriceps function | Assessed by leg dynamometry (Biodex) | 0 and 4weeks |
| Change in blood pressure | Measured with a hematometer | 0 and 4 weeks |
| Change in heart rate | Measured with a hematometer | 0 and 4 weeks |
| 0 and 4 weeks |
| Severity of dyspnea and COPD | Assessed by:
| 0 and 4 weeks |
| Sleep pattern | Assess by Pittburgh Sleep Quality Index (PSQI) | 0 and 4 weeks |
| Food intake | Assessed by food anamnesis questionnaire | 0 and 4 weeks |
| Resveratrol and dihydroresveratrol concentrations | Assessed by blood sampling | 0 and 4 weeks |
| Electrocardiogram | Measured with a ECG | 0 and 4 weeks |
| Safety parameters | Assessed in blood:
| 0 and 4 weeks |
| Baseline lung function | Assessed by spirometry | 0 weeks |
| Background |
| van den Borst B, Gosker HR, Schols AM. Central fat and peripheral muscle: partners in crime in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2013 Jan 1;187(1):8-13. doi: 10.1164/rccm.201208-1441OE. No abstract available. |
| 31996311 | Derived | Beijers RJ, Gosker HR, Sanders KJ, de Theije C, Kelders M, Clarke G, Cryan JF, van den Borst B, Schols AM. Resveratrol and metabolic health in COPD: A proof-of-concept randomized controlled trial. Clin Nutr. 2020 Oct;39(10):2989-2997. doi: 10.1016/j.clnu.2020.01.002. Epub 2020 Jan 13. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |