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Pulmonary Disease, Chronic ObstructiveCARMENSNCT02245932

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

A study testing Resveratrol in people with Pulmonary Disease, Chronic Obstructive, run by Maastricht University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Resveratrol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
1 siteNetherlands
Study dates
Jan 2015to Nov 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • COPD patients
  • Current or ex-smoker
  • Age >18 years

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Maastricht University Medical Center

    Maastricht, Limburg

Other trials in Netherlands

About this study

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

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.

Read the 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.

Being tested
Resveratrol, Placebo
Keywords
Pulmonary disease, Chronic Obstructive, Cardiovascular diseases, Metabolism, Resveratrol
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ResveratrolDietary supplement

    Also called resVida (99% pure trans-resveratrol) provided by DSM Nutritional Products, Ltd.

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

  • PlaceboDietary supplement

    4 weeks of placebo supplementation (two doses per day)

Study groups in NCT02245932
Study groupRoleWhat they receive
Resveratrol supplementationExperimental150 mg of resveratrol for 4 weeks (split over two doses of 75 mg/day)
Receives: Dietary Supplement: Resveratrol
Placebo supplementationPlacebo comparatorPlacebo for 4 weeks (split over two doses per day)
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in mitochondrial function

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

    Measured: 0 and 4 weeks

Secondary outcomes (9)

  1. 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.

    Measured: 0 and 4 weeks

  2. Change in adipose tissue inflammation

    Assessed by adipose tissue biopsy

    Measured: 0 and 4 weeks

  3. Change in systematic inflammatory profile

    Assessed via blood sampling

    Measured: 0 and 4 weeks

  4. Change in lipid profile

    Assessed via blood sampling

    Measured: 0 and 4 weeks

  5. Change in insulin sensitivity

    Assessed by HOMA-IR

    Measured: 0 and 4 weeks

  6. Change in body composition

    Assessed by:

    • DEXA-scan
    • Anthropometric measurements

    Measured: 0 and 4 weeks

  7. Change in quadriceps function

    Assessed by leg dynamometry (Biodex)

    Measured: 0 and 4weeks

  8. Change in blood pressure

    Measured with a hematometer

    Measured: 0 and 4 weeks

  9. Change in heart rate

    Measured with a hematometer

    Measured: 0 and 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionNov 2017
  4. Study completionNov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02245932
Sponsor's protocol ID
143031
Other IDs
3.4.12.023
Acronym
CARMENS
Status last verified
Sep 2016
First submitted
16 Sep 2014
Last updated
17 May 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22055504

  • 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.

    PubMed 23281350

  • 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.

    PubMed 31996311

Questions about this trial

What is this clinical trial studying?

A study testing Resveratrol in people with Pulmonary Disease, Chronic Obstructive, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in mitochondrial function (time frame: 0 and 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02245932, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2019.

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