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A weight-loss Mediterranean diet/lifestyle intervention ameliorates inflammation and oxidative stress in patients with obstructive sleep apnea: results of the “MIMOSA” randomized clinical trial

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Abstract

Purpose

Inflammation and oxidative stress are implicated in obstructive sleep apnea (OSA) pathophysiology. We aimed at exploring whether the combination of a weight-loss Mediterranean diet/lifestyle intervention with OSA standard care, i.e., continuous positive airway pressure (CPAP) prescription, can lead to greater improvements in inflammation and oxidative stress, compared to standard care alone.

Methods

This was a randomized controlled clinical trial in 187 adult, overweight patients with moderate-to-severe OSA. Participants were randomized to a standard care (SCG, n = 65), a Mediterranean diet (MDG, n = 62) or a Mediterranean lifestyle group (MLG, n = 60). All groups received OSA standard care. Intervention arms participated in a 6-month behavioral weight-loss intervention based on the Mediterranean diet, while the MLG also received counselling on physical activity and sleep habits.

Results

Seven patients were excluded and 53/180 were lost to follow-up. In intention to treat analysis (n = 180), the SCG did not exhibit changes in any of the markers assessed. Post-intervention age-, sex-, baseline- and CPAP use-adjusted plasma high sensitivity C-reactive protein levels (mg/L) were lower in the MDG and the MLG compared to the SCG (mean difference − 1.33, P = 0.039 and − 1.68, P = 0.007, respectively). The MLG also exhibited lower urinary 8-iso prostaglandin F2a levels (ng/mg creatinine) compared to the SCG and the MDG (mean difference − 1.10, P < 0.0001 and − 0.80, P = 0.001, respectively). Adiponectin and oxidized guanine levels were not altered in any of the study groups. Results were similar in per protocol analysis (n = 127).

Conclusion

A weight-loss Mediterranean diet/lifestyle intervention on top of CPAP has anti-inflammatory and antioxidant benefits in OSA.

Registration

The trial was prospectively registered at ClinicalTrials.gov (NCT02515357) on August 4, 2015.

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Data availability

Data are available from the authors on request.

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Acknowledgements

The authors would like to thank Mrs. Pavlina Ouzounidou, Medical Nurse, 1st Department of Critical Care and Pulmonary Services, Medical School of Athens University, Evangelismos Hospital, Athens, Greece, and Mrs. Antigoni Tsiafitsa, Laboratory Staff, Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University, Athens, Greece, for their help in collecting patient’s blood samples.

Funding

This research was co-financed by Greece and the European Union (European Social Fund—ESF) through the Operational Programme «Human Resources Development, Education and Lifelong Learning 2014–2020» in the context of the project “The effects of a lifestyle intervention on the cardiometabolic profile of patients with obstructive sleep apnea” (MIS 5049027). The funder had no involvement in study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the article for publication.

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Contributions

MDK, NY, and EV conceived the study’s research hypothesis and objectives. MDK conceived the study’s design and was responsible for the coordination and supervision of the research activity. MG, RT, EF, IK, KL, and EP were involved in participant recruitment and assessments. MG was responsible for the delivery of the dietary/lifestyle intervention, drafted the initial manuscript, and performed statistical analyses. All authors critically reviewed the manuscript, contributed to further drafts, and approved the final version. MDK is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Corresponding author

Correspondence to Meropi D. Kontogianni.

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The study was approved by the Scientific Board of “Evangelismos” Hospital, Athens, Greece and the Bioethics Committee of Harokopio University, Athens, Greece, and was conducted in accordance with the Declaration of Helsinki.

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Georgoulis, M., Yiannakouris, N., Tenta, R. et al. A weight-loss Mediterranean diet/lifestyle intervention ameliorates inflammation and oxidative stress in patients with obstructive sleep apnea: results of the “MIMOSA” randomized clinical trial. Eur J Nutr 60, 3799–3810 (2021). https://doi.org/10.1007/s00394-021-02552-w

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