ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02245932
Recruitment Status : Completed
First Posted : September 22, 2014
Last Update Posted : March 22, 2018
Sponsor:
Collaborators:
The Netherlands Asthma Foundation
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
The overall objective is to investigate the efficacy of resveratrol in modulating metabolism and CVD risk profile in patients with COPD. The primary objective is to investigate the effect of resveratrol on CRP as clinical marker of low grade systemic inflammation. 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 low grade systemic inflammation and by resveratrol.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Dietary Supplement: Resveratrol Dietary Supplement: Placebo Not Applicable

Detailed Description:

Rationale: In the general population cardiovascular disease (CVD) is the leading cause of mortality and it is well established that obesity (body mass index >30 kg/m²) is an important determinant. The risk is even further increased in COPD, due to smoking behaviour and accumulation of visceral fat combined with a decreased skeletal muscle oxidative capacity. Enhanced systemic inflammation is identified as important driver in recent epidemiological and translational research. Aerobic exercise training (AET) is an established way to improve metabolic health and decrease CVD risk in the overweight general population but modulating potential is limited in COPD due to ventilatory limitations and related disease symptoms. Interventions which mimic the effects of AET are therefore considered as unmet medical need. Evidence is emerging that the nutritional supplement resveratrol is an interesting candidate that requires further investigation in COPD.

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Resveratrol on Metabolism and Cardiovascular Risk Profile in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Actual Study Start Date : January 2015
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
Drug Information available for: Resveratrol

Arm Intervention/treatment
Experimental: Resveratrol supplementation
150 mg of resveratrol for 4 weeks (split over two doses of 75 mg/day)
Dietary Supplement: Resveratrol
4 weeks of 150 mg resveratrol (2 times 75mg/day)
Other Name: resVida (99% pure trans-resveratrol) provided by DSM Nutritional Products, Ltd.

Placebo Comparator: Placebo supplementation
Placebo for 4 weeks (split over two doses per day)
Dietary Supplement: Placebo
4 weeks of placebo supplementation (two doses per day)




Primary Outcome Measures :
  1. Change from baseline in high sensitivity systemic inflammation (CRP) at 12 weeks [ Time Frame: 0 and 12 weeks ]
    High sensitivity C-reactive protein (CRP) as a clinical marker of systemic inflammation via blood sampling.


Secondary Outcome Measures :
  1. Mitochondrial function [ Time Frame: 0 and 4 weeks ]
    Assessed by muscle biopsy of the quadriceps muscle (vastus lateralis)

  2. Adipose tissue inflammation [ Time Frame: 0 and 4 weeks ]
    Assessed by adipose tissue biopsy

  3. Systematic inflammatory profile [ Time Frame: 0 and 4 weeks ]
    Assessed via blood sampling

  4. Lipid profile [ Time Frame: 0 and 4 weeks ]
    Assessed via blood sampling

  5. Insulin sensitivity [ Time Frame: 0 and 4 weeks ]
    Assessed by HOMA-IR

  6. Body composition [ Time Frame: 0 and 4 weeks ]

    Assessed by:

    • DEXA-scan
    • Anthropometric measurements

  7. Quadriceps function [ Time Frame: 0 and 4weeks ]
    Assessed by leg dynamometry (Biodex)

  8. Blood pressure [ Time Frame: 0 and 4 weeks ]
    Measured with a hematometer

  9. Heart rate [ Time Frame: 0 and 4 weeks ]
    Measured with a hematometer

  10. Lung function [ Time Frame: 0 and 4 weeks ]
    Assessed by spirometry


Other Outcome Measures:
  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. Quality of life [ Time Frame: 0 and 4 weeks ]

    Assessed by:

    • St. Georges quality of life questionnaire (SGRQ)
    • Short Form Health Survey (SF-36)
    • EuroQol 5 Dimension (EQ-5D)

  4. 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)

  5. Sleep pattern [ Time Frame: 0 and 4 weeks ]
    Assess by Pittburgh Sleep Quality Index (PSQI)

  6. Food intake [ Time Frame: 0 and 4 weeks ]
    Assessed by food anamnesis questionnaire

  7. Resveratrol and dihydroresveratrol concentrations [ Time Frame: 0 and 4 weeks ]
    Assessed by blood sampling

  8. Electrocardiogram [ Time Frame: 0 and 4 weeks ]
    Measured with a ECG

  9. Safety parameters [ Time Frame: 0 and 4 weeks ]

    Assessed in blood:

    • Creatinine
    • Urea
    • Sodium
    • Potassium
    • Gamma-GT
    • ALAT
    • ASAT
    • Alkaline Phosphatase



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02245932


Locations
Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
The Netherlands Asthma Foundation
DSM Nutritional Products, Inc.
Investigators
Principal Investigator: Annemie Schols, Prof. Maastricht University Medical Center

Publications:
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02245932     History of Changes
Other Study ID Numbers: 143031
3.4.12.023 ( Other Grant/Funding Number: The Netherlands Lung Foundation )
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: September 2016

Keywords provided by Maastricht University Medical Center:
Pulmonary disease, Chronic Obstructive
Cardiovascular diseases
Metabolism
Resveratrol

Additional relevant MeSH terms:
Resveratrol
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents