The effect of resveratrol on metabolism and cardiovascular risk profile in patients with chronic obstructive pulmonary disease (COPD)

The effect of resveratrol on metabolism and cardiovascular risk profile in patients with chronic obstructive pulmonary disease (COPD) - CARMENS-trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44730

Enrollment

Registered

2014-09-10

Start date

2016-08-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary disease

Interventions

Subjects will be randomized to one of the research groups. The groups will receive the following intervention: - Group 1 will receive a dose of 150 mg of resveratrol for 4 weeks (2 capsules of 220 m

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - COPD (GOLD I-IV); - Current or ex-smoker; - Age >18 years.

Exclusion criteria

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 ( 20 grams alcohol/day; - Intake of resveratrol containing dietary supplements;

Design outcomes

Primary

Measure	Time frame
Primary outcome of this study is: High sensitivity systemic inflammation (CRP) as a clinical marker of systemic inflammation via blood sampling.	—

Secondary

Measure	Time frame
Secondary outcomes of this study are: Proposed mechanisms of action: 1. Quadriceps metabolism and mitochondrial function via vastus lateralis muscle biopsy and muscle cross-sectional area; 2. Adipose tissue inflammation via abdominal subcutaneous adipose tissue biopsy (macrophage infiltration, adipocytes size, inflammatory and metabolic gene expression); 3. Systemic inflammatory (IL-6, TNF-a, leptin and adiponectin) and oxidative stress markers, cellular redox status and glutathionylation of haemoglobin via blood sampling; 4. Lipid profile (triglyceride, total cholesterol, HDL cholesterol, apoA1, apoB100) via blood sampling; 5. Insulin sensitivity: Homeostatis Model Assessment of insulin resistance (HOMA-IR) index (blood); General markers of body composition and health status known to be affected by CRP: 1. Body fat mass and distribution: Whole-body fat mass (DXA scan and anthropometric measurements) and visceral fat (DXA scan); 2. Quadriceps function by leg dynamometry (Biodex); 3. Blood pressure and heart rate (hematometer); 4. Physical activity level	—

Measure

Time frame

Secondary outcomes of this study are: Proposed mechanisms of action: 1. Quadriceps metabolism and mitochondrial function via vastus lateralis muscle biopsy and muscle cross-sectional area; 2. Adipose tissue inflammation via abdominal subcutaneous adipose tissue biopsy (macrophage infiltration, adipocytes size, inflammatory and metabolic gene expression); 3. Systemic inflammatory (IL-6, TNF-a, leptin and adiponectin) and oxidative stress markers, cellular redox status and glutathionylation of haemoglobin via blood sampling; 4. Lipid profile (triglyceride, total cholesterol, HDL cholesterol, apoA1, apoB100) via blood sampling; 5. Insulin sensitivity: Homeostatis Model Assessment of insulin resistance (HOMA-IR) index (blood); General markers of body composition and health status known to be affected by CRP: 1. Body fat mass and distribution: Whole-body fat mass (DXA scan and anthropometric measurements) and visceral fat (DXA scan); 2. Quadriceps function by leg dynamometry (Biodex); 3. Blood pressure and heart rate (hematometer); 4. Physical activity level

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)