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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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
PACTR
Registry ID
PACTR202303690944300
Enrollment
90
Registered
2023-03-20
Start date
2023-01-15
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Respiratory

Interventions

zinc enriched spirulina supplementation
Control group to the G1

Sponsors

Laboratory bio algues
Collaborator

Eligibility

Sex/Gender
Male

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
the determination of antioxidant status (SOD, GPX, TAC, Homocysteine, uric acid)

Secondary

MeasureTime frame
Symptom scores (mMRC) Social disadvantage (CAT, HAD) Exercise tolerance (6MWT, Voorrips questionnaire) Lung function (FEV1, FEV1/FVC, FEV1%, TLC, FRC, RV, TLCO) Endothelial function Inflammatory indicators (CRP, IL6) HbA1c

Countries

Tunisia

Contacts

Public ContactKhawla Mahmoudi

University of Sousse

khawlamahmoudi30@gmail.com+21655939314

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026