Clinical trial NCT02245932: Resveratrol In Chronic Obstructive Pulmonary Disease (COPD) Patients (CARMENS-trial)
Official title: The Effect of Resveratrol on Metabolism and Cardiovascular Risk Profile in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary disease, Chronic Obstructive
Cardiovascular diseases
Metabolism
Resveratrol
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: The Netherlands Asthma Foundation
name: DSM Nutritional Products, Inc.
First posted: 2014-09-22
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* COPD patients
* Current or ex-smoker
* Age \>18 years

Exclusion Criteria:

* COPD patients planned for pulmonary rehabilitation or who recently participated in a rehabilitation program in the previous 6 months
* Investigator's uncertainty about willingness or ability of the patient to comply with the protocol requirements
* Participation in any other study involving investigational exercise training, nutritional or pharmacological intervention
* Oral glucocorticoid use
* Recent exacerbation (\<4 weeks) that required oral steroids and/or hospital admission
* Subject is pregnant, planning to be pregnant during the study period, lactating, or women who consider themselves to be of childbearing potential and who are engaged in an active sex life and are unwilling to commit to the use of an approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation;
* Diabetes mellitus (all types), active cardiovascular disease or a cardiovascular event (such as myocardial infarction, cerebrovascular haemorrhage/infarction) in the previous 6 months, recent major surgery, thyroid dysfunction, hepatic or renal disorders, current malignancy (except for dermal malignancies) or central or obstructive sleep apnea;
* Current alcohol consumption \> 20 grams alcohol/day;
* Intake of resveratrol containing dietary supplements.

Primary outcomes:
measure: Change in mitochondrial function
timeFrame: 0 and 4 weeks
Secondary outcomes:
measure: Change from baseline in high sensitivity systemic inflammation (CRP) at 4 weeks
timeFrame: 0 and 4 weeks
measure: Change in adipose tissue inflammation
timeFrame: 0 and 4 weeks
measure: Change in systematic inflammatory profile
timeFrame: 0 and 4 weeks
measure: Change in lipid profile
timeFrame: 0 and 4 weeks
measure: Change in insulin sensitivity
timeFrame: 0 and 4 weeks
measure: Change in body composition
timeFrame: 0 and 4 weeks
measure: Change in quadriceps function
timeFrame: 0 and 4weeks
measure: Change in blood pressure
timeFrame: 0 and 4 weeks
measure: Change in heart rate
timeFrame: 0 and 4 weeks
Other outcomes:
measure: Medical history
timeFrame: 0 and 4 weeks
measure: Physical activity
timeFrame: 0 and 4 weeks
measure: Severity of dyspnea and COPD
timeFrame: 0 and 4 weeks
measure: Sleep pattern
timeFrame: 0 and 4 weeks
measure: Food intake
timeFrame: 0 and 4 weeks
measure: Resveratrol and dihydroresveratrol concentrations
timeFrame: 0 and 4 weeks
measure: Electrocardiogram
timeFrame: 0 and 4 weeks
measure: Safety parameters
timeFrame: 0 and 4 weeks
measure: Baseline lung function
timeFrame: 0 weeks
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Annemie Schols, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.