MedPath

Impacts of Zinc enriched Spirulina supplementation on antioxidant capacity, pulmonary function, endothelial damage and social disadvantage data of Chronic Obstructive Pulmonary Disease patients: a Tunisian pilot study

Phase 2
Recruiting
Conditions
Respiratory
Registration Number
PACTR202303690944300
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Male
Target Recruitment
90
Inclusion Criteria

Two groups will be included in this study. The following inclusion criteria will be applied:
- A first group (Group G1) will be formed by COPD male subjects aged 20 to 65 years. The COPD obstruction must be classified mild, moderate or severe according to GOLD guidelines respectively
- A second group (Group G2) will be formed by COPD male adults aged 20-65 years. the postbronchodilator FEV1 must be higher than 30% of predicted value. This group will serve as a control for the G1.

Exclusion Criteria

-contra-indications to 6MWT (signs of unstable angina or myocardial infarction within the previous month, resting heart rate = 120 bpm, systolic blood pressure = 180 mmHg, diastolic blood pressure = 100 mmHg)
-Patients with limited physical activity and who cannot perform 6MWT (A known neuromuscular, orthopedic, rheumatologic or vascular disorders affecting the ability to exercise)
-Patient who has been in further clinical trials in the previous year.
-contra-indications to plethysmography.
-deterioration of clinical status requiring hospitalization 3 months before the study
-Asthmatic disease, Asthma-COPD Overlap
-An upper airway abnormality.
-History of chronic diseases (cardiac, renal, gastrointestinal, neurological; otorhinolaryngologic).
-Acute upper respiratory tract infection during the three weeks preceding the evaluation
-Acute exacerbation of COPD in the last 4 weeks.
-Clinical manifestations of allergic diseases (urticaria, skin allergy, atopic dermatitis, eczema)
-Inability to perform respiratory maneuvers properly

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath