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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Resveratrol
Placebo
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary disease, Chronic Obstructive, Cardiovascular diseases, Metabolism, Resveratrol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Resveratrol supplementation

Placebo supplementation

Arm Description

150 mg of resveratrol for 4 weeks (split over two doses of 75 mg/day)

Placebo for 4 weeks (split over two doses per day)

Outcomes

Primary Outcome Measures

Change in mitochondrial function
Assessed by measuring mitochondrial respiration (using the oxygraph) of a muscle biopsy of the quadriceps muscle (vastus lateralis)

Secondary Outcome Measures

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.
Change in adipose tissue inflammation
Assessed by adipose tissue biopsy
Change in systematic inflammatory profile
Assessed via blood sampling
Change in lipid profile
Assessed via blood sampling
Change in insulin sensitivity
Assessed by HOMA-IR
Change in body composition
Assessed by: DEXA-scan Anthropometric measurements
Change in quadriceps function
Assessed by leg dynamometry (Biodex)
Change in blood pressure
Measured with a hematometer
Change in heart rate
Measured with a hematometer

Full Information

First Posted
September 16, 2014
Last Updated
May 16, 2019
Sponsor
Maastricht University Medical Center
Collaborators
The Netherlands Asthma Foundation, DSM Nutritional Products, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02245932
Brief Title
Resveratrol In Chronic Obstructive Pulmonary Disease (COPD) Patients (CARMENS-trial)
Acronym
CARMENS
Official Title
The Effect of Resveratrol on Metabolism and Cardiovascular Risk Profile in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
The Netherlands Asthma Foundation, DSM Nutritional Products, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Pulmonary disease, Chronic Obstructive, Cardiovascular diseases, Metabolism, Resveratrol

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resveratrol supplementation
Arm Type
Experimental
Arm Description
150 mg of resveratrol for 4 weeks (split over two doses of 75 mg/day)
Arm Title
Placebo supplementation
Arm Type
Placebo Comparator
Arm Description
Placebo for 4 weeks (split over two doses per day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Resveratrol
Other Intervention Name(s)
resVida (99% pure trans-resveratrol) provided by DSM Nutritional Products, Ltd.
Intervention Description
4 weeks of 150 mg resveratrol (2 times 75mg/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
4 weeks of placebo supplementation (two doses per day)
Primary Outcome Measure Information:
Title
Change in mitochondrial function
Description
Assessed by measuring mitochondrial respiration (using the oxygraph) of a muscle biopsy of the quadriceps muscle (vastus lateralis)
Time Frame
0 and 4 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in high sensitivity systemic inflammation (CRP) at 4 weeks
Description
High sensitivity C-reactive protein (CRP) as a clinical marker of systemic inflammation via blood sampling.
Time Frame
0 and 4 weeks
Title
Change in adipose tissue inflammation
Description
Assessed by adipose tissue biopsy
Time Frame
0 and 4 weeks
Title
Change in systematic inflammatory profile
Description
Assessed via blood sampling
Time Frame
0 and 4 weeks
Title
Change in lipid profile
Description
Assessed via blood sampling
Time Frame
0 and 4 weeks
Title
Change in insulin sensitivity
Description
Assessed by HOMA-IR
Time Frame
0 and 4 weeks
Title
Change in body composition
Description
Assessed by: DEXA-scan Anthropometric measurements
Time Frame
0 and 4 weeks
Title
Change in quadriceps function
Description
Assessed by leg dynamometry (Biodex)
Time Frame
0 and 4weeks
Title
Change in blood pressure
Description
Measured with a hematometer
Time Frame
0 and 4 weeks
Title
Change in heart rate
Description
Measured with a hematometer
Time Frame
0 and 4 weeks
Other Pre-specified Outcome Measures:
Title
Medical history
Description
Medication use
Time Frame
0 and 4 weeks
Title
Physical activity
Description
Assessed by: Accelerometry Short Questionnaire to Assess Health (SQUASH)
Time Frame
0 and 4 weeks
Title
Severity of dyspnea and COPD
Description
Assessed by: Medical Research Council scale (MRC-scale) COPD assessment test (CAT) Clinical COPD Questionnaire (CCQ)
Time Frame
0 and 4 weeks
Title
Sleep pattern
Description
Assess by Pittburgh Sleep Quality Index (PSQI)
Time Frame
0 and 4 weeks
Title
Food intake
Description
Assessed by food anamnesis questionnaire
Time Frame
0 and 4 weeks
Title
Resveratrol and dihydroresveratrol concentrations
Description
Assessed by blood sampling
Time Frame
0 and 4 weeks
Title
Electrocardiogram
Description
Measured with a ECG
Time Frame
0 and 4 weeks
Title
Safety parameters
Description
Assessed in blood: Creatinine Urea Sodium Potassium Gamma-GT ALAT ASAT Alkaline Phosphatase
Time Frame
0 and 4 weeks
Title
Baseline lung function
Description
Assessed by spirometry
Time Frame
0 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annemie Schols, Prof.
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
22055504
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.
Results Reference
background
PubMed Identifier
23281350
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.
Results Reference
background
PubMed Identifier
31996311
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.
Results Reference
derived

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

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