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Completed

NCT Number: NCT02245932

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resveratrol

Dietary Supplement

4 weeks of 150 mg resveratrol (2 times 75mg/day)

Other names: resVida (99% pure trans-resveratrol) provided by DSM Nutritional Products, Ltd.

Placebo

Dietary Supplement

4 weeks of placebo supplementation (two doses per day)

Primary outcomes

  1. Change in mitochondrial function

    Time frame: 0 and 4 weeks

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

Secondary outcomes

  1. Change from baseline in high sensitivity systemic inflammation (CRP) at 4 weeks

    Time frame: 0 and 4 weeks

    High sensitivity C-reactive protein (CRP) as a clinical marker of systemic inflammation via blood sampling.

  2. Change in adipose tissue inflammation

    Time frame: 0 and 4 weeks

    Assessed by adipose tissue biopsy

  3. Change in systematic inflammatory profile

    Time frame: 0 and 4 weeks

    Assessed via blood sampling

  4. Change in lipid profile

    Time frame: 0 and 4 weeks

    Assessed via blood sampling

  5. Change in insulin sensitivity

    Time frame: 0 and 4 weeks

    Assessed by HOMA-IR

  6. Change in body composition

    Time frame: 0 and 4 weeks

    Assessed by:

    • DEXA-scan
    • Anthropometric measurements
  7. Change in quadriceps function

    Time frame: 0 and 4weeks

    Assessed by leg dynamometry (Biodex)

  8. Change in blood pressure

    Time frame: 0 and 4 weeks

    Measured with a hematometer

  9. Change in heart rate

    Time frame: 0 and 4 weeks

    Measured with a hematometer

Other outcomes

  1. Medical history

    Time frame: 0 and 4 weeks

    Medication use

  2. Physical activity

    Time frame: 0 and 4 weeks

    Assessed by:

    • Accelerometry
    • Short Questionnaire to Assess Health (SQUASH)
  3. Severity of dyspnea and COPD

    Time frame: 0 and 4 weeks

    Assessed by:

    • Medical Research Council scale (MRC-scale)
    • COPD assessment test (CAT)
    • Clinical COPD Questionnaire (CCQ)
  4. Sleep pattern

    Time frame: 0 and 4 weeks

    Assess by Pittburgh Sleep Quality Index (PSQI)

  5. Food intake

    Time frame: 0 and 4 weeks

    Assessed by food anamnesis questionnaire

  6. Resveratrol and dihydroresveratrol concentrations

    Time frame: 0 and 4 weeks

    Assessed by blood sampling

  7. Electrocardiogram

    Time frame: 0 and 4 weeks

    Measured with a ECG

  8. Safety parameters

    Time frame: 0 and 4 weeks

    Assessed in blood:

    • Creatinine
    • Urea
    • Sodium
    • Potassium
    • Gamma-GT
    • ALAT
    • ASAT
    • Alkaline Phosphatase
  9. Baseline lung function

    Time frame: 0 weeks

    Assessed by spirometry

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • The Netherlands Asthma Foundation
  • dsm-firmenich Switzerland AG

Registry information

Official study title

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

Acronym: CARMENS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 22, 2014
Registry last updated
May 17, 2019

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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