Resveratrol In Chronic Obstructive Pulmonary Disease (COPD) Patients (CARMENS-trial)

Pulmonary Disease, Chronic Obstructive Clinical Trial

— CARMENS  

Official title:

The Effect of Resveratrol on Metabolism and Cardiovascular Risk Profile in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02245932
• Other study ID #: 143031
• Secondary ID: 3.4.12.023
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: November 2017

Study information

• Verified date: September 2016
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Dietary Supplement:
• Resveratrol
4 weeks of 150 mg resveratrol (2 times 75mg/day)
• Placebo
4 weeks of placebo supplementation (two doses per day)

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University Medical Center	DSM Nutritional Products, Inc., The Netherlands Asthma Foundation

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medical history	Medication use	0 and 4 weeks
Other	Physical activity	Assessed by: Accelerometry; Short Questionnaire to Assess Health (SQUASH)	0 and 4 weeks
Other	Severity of dyspnea and COPD	Assessed by: Medical Research Council scale (MRC-scale); COPD assessment test (CAT); Clinical COPD Questionnaire (CCQ)	0 and 4 weeks
Other	Sleep pattern	Assess by Pittburgh Sleep Quality Index (PSQI)	0 and 4 weeks
Other	Food intake	Assessed by food anamnesis questionnaire	0 and 4 weeks
Other	Resveratrol and dihydroresveratrol concentrations	Assessed by blood sampling	0 and 4 weeks
Other	Electrocardiogram	Measured with a ECG	0 and 4 weeks
Other	Safety parameters	Assessed in blood: Creatinine; Urea; Sodium; Potassium; Gamma-GT; ALAT; ASAT; Alkaline Phosphatase	0 and 4 weeks
Other	Baseline lung function	Assessed by spirometry	0 weeks
Primary	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
Secondary	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
Secondary	Change in adipose tissue inflammation	Assessed by adipose tissue biopsy	0 and 4 weeks
Secondary	Change in systematic inflammatory profile	Assessed via blood sampling	0 and 4 weeks
Secondary	Change in lipid profile	Assessed via blood sampling	0 and 4 weeks
Secondary	Change in insulin sensitivity	Assessed by HOMA-IR	0 and 4 weeks
Secondary	Change in body composition	Assessed by: DEXA-scan; Anthropometric measurements	0 and 4 weeks
Secondary	Change in quadriceps function	Assessed by leg dynamometry (Biodex)	0 and 4weeks
Secondary	Change in blood pressure	Measured with a hematometer	0 and 4 weeks
Secondary	Change in heart rate	Measured with a hematometer	0 and 4 weeks