Effects of a calorie-restricted MIND diet and probiotic supplementation on fertility, sexual function, and quality of sexual life in overweight and obese men: protocol for a double-blind randomized clinical trial.
Ali Shamsi-Goushki, Mohammad Reza Mahmoodi, Sareh Ashourzadeh, Majid Khadem-Rezaiyan, Reza Rezvani
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引用次数: 0
Abstract
Background: MIND diets and probiotics have the potential to positively affect infertility in obese and overweight men, but their effects are not yet fully elucidated. Therefore, this study aims, for the first time, to address this gap by evaluating the effects of a calorie-restricted MIND diet and probiotic supplementation on fertility, sexual function, and quality of sexual life in overweight and obese men.
Methods: This study will be conducted as a double-blind randomized clinical trial on 84 overweight and obese men in Kerman for 3 months. Participants will be randomly allocated to one of the following four groups: (1) the group receiving the MIND diet with restricted calories + probiotic supplement; (2) the group receiving the MIND diet with restricted calories + placebo; (3) the group receiving a standard low-calorie diet + probiotic supplement; (4) the group receiving a standard low-calorie diet + placebo. Before the intervention and after 3 months, the study variables will be compared between groups. Anthropometric evaluation, spermogram evaluation, serum levels of androgens, sexual function, and quality of sexual life will be assessed at the beginning and at the end of the study.
Discussion: This trial will provide valuable evidence regarding the potential synergistic effects of the MIND diet and probiotic supplementation in managing male infertility associated with obesity. By evaluating both clinical fertility markers and patient-reported outcomes such as sexual function and quality of life, the study findings are expected to contribute to a better understanding of the role of lifestyle interventions in reproductive health, potentially offering a sustainable therapeutic approach for this population.
Ethical aspects: All the work procedures will be carried out in accordance with the guidelines recommended by the Ethics Committee of Mashhad University of Medical Sciences (IR.MUMS.REC.1402.341).
Trial registration: Iranian Registry of Clinical Trials IRCT20240313061277N1. Registered on 31 March 2024.
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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