Impacts of zinc enriched spirulina as an adjunct to conventional treatment of patients with Chronic Obstructive Pulmonary Disease: Study protocol for a North African randomized controlled trial (SPIRICOPD).

Introduction: Chronic Obstructive Pulmonary Disease (COPD) is a respiratory condition strongly related to oxidative stress. Recent studies have explored the potential benefits of nutritional supplementation in managing several conditions.

Aim: To investigate the effects of zinc-enriched Spirulina Supplementation (ZSS) on patients with COPD.

Methods: This study is a monocentric randomized controlled clinical trial. COPD-eligible adult male patients under 65 years of age, receiving regular medical treatment, will be included. They will continue their conventional medical treatment following the GOLD 2023 guidelines for COPD. Ninety subjects will be randomly assigned to either the experimental group (G1) or the control group (G2) in a 1:1 ratio. G1 will receive ZSS (1 g/day) for 2 months, while G2 will continue only basic medical treatment. The study will assess oxidant-antioxidant balance, lung function through pulmonary function tests, functional capacity via the 6-minute walking test, lipid profile, dyspnea, and health-related quality of life. All outcomes will be measured at baseline and two months later after supplementation completion. After the 8-week treatment, patients will be followed up for an additional 4 weeks. Ethics approval was obtained from the faculty of medicine of Sousse ethics committee.

Expected results: It is expected that ZSS can positively impact the oxidant/antioxidant balance in patients with COPD after two months of supplementation. The authors anticipate that ZSS may improve various physiological parameters, such as lung function, exercise capacity, endothelial function, and metabolic profile, leading to an overall improvement in the quality of life of patients with COPD.