NCT02245932

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

May 17, 2019

Status Verified

September 1, 2016

Enrollment Period

2.8 years

First QC Date

September 16, 2014

Last Update Submit

May 16, 2019

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary disease, Chronic ObstructiveCardiovascular diseasesMetabolismResveratrol

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

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

    0 and 4 weeks

  • Change in adipose tissue inflammation

    0 and 4 weeks

  • Change in systematic inflammatory profile

    0 and 4 weeks

  • Change in lipid profile

    0 and 4 weeks

  • Change in insulin sensitivity

    0 and 4 weeks

  • +4 more secondary outcomes

Other Outcomes (9)

  • Medical history

    0 and 4 weeks

  • Physical activity

    0 and 4 weeks

  • Severity of dyspnea and COPD

    0 and 4 weeks

  • +6 more other outcomes

Study Arms (2)

Resveratrol supplementation

EXPERIMENTAL

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

Dietary Supplement: Resveratrol

Placebo supplementation

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

ResveratrolDIETARY_SUPPLEMENT

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

Also known as: resVida (99% pure trans-resveratrol) provided by DSM Nutritional Products, Ltd.
Resveratrol supplementation
PlaceboDIETARY_SUPPLEMENT

4 weeks of placebo supplementation (two doses per day)

Placebo supplementation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 22055504BACKGROUND

  • 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.

    PMID: 23281350BACKGROUND

  • 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.

    PMID: 31996311DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveCardiovascular Diseases

Interventions

ResveratrolLong-Term Synaptic Depression

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenolsNeuronal PlasticityNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Annemie Schols, Prof.

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2014

First Posted

September 22, 2014

Study Start

January 1, 2015

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

May 17, 2019

Record last verified: 2016-09

Locations

NL(1)