The goal of this clinical trial is to learn whether drinking a daily serving of gazpacho can improve semen quality in men with reduced sperm quality. The study will also examine how this dietary intervention affects oxidative stress and whether it is well tolerated.
The main questions this study aims to answer are:
* Does daily consumption of gazpacho improve semen quality in men with altered semen parameters? * Does this dietary intervention affect levels of oxidative stress in semen? * Is daily gazpacho intake feasible and well tolerated as part of a Mediterranean diet?
Researchers will compare a Mediterranean diet plus daily gazpacho intake with a Mediterranean diet alone to determine whether adding gazpacho provides additional benefits for male reproductive health.
Participants will:
* Follow a standardized Mediterranean diet for 12 weeks * Drink 330 mL of gazpacho every day or follow the diet without gazpacho * Provide semen samples at the start of the study and after 12 weeks * Complete a short diary to record adherence to the dietary intervention * Be followed for up to 18 months to record reproductive outcomes
Men aged 18 to 45 years
Andrological profile including altered semen parameters such as oligozoospermia, asthenozoospermia and/or teratozoospermia (O±A±T)
No clinical indication for sperm DNA fragmentation testing or advanced sperm selection techniques
Willingness and ability to comply with the study protocol, including adherence to a standardized Mediterranean diet
Use of antioxidant supplements during the three months prior to study start.
Active smokers or men who have stopped smoking within the last three months.
Diagnosis of azoospermia, leucocytospermia or necrozoospermia.
Presence of severe systemic diseases or chronic conditions that could interfere with semen quality or adherence to the study.
Parallel
Standardized Mediterranean Diet
Other interventionParticipants will follow a standardized Mediterranean diet for a period of 12 weeks. The dietary pattern emphasizes the consumption of vegetables, fruits, legumes, whole grains, olive oil as the main source of fat, moderate intake of fish and nuts, and limited intake of red and processed meats.
Gazpacho
Dietary supplementParticipants will consume 330 mL per day of commercially available gazpacho, taken once daily with a main meal, for a period of 12 weeks. The gazpacho will be consumed as part of the daily diet in addition to a standardized Mediterranean diet.
Change in Ejaculate Volume (mL)
Semen volume measured according to WHO 2021 semen analysis guidelines. This outcome will be analyzed and reported as an independent measure of semen quality. No composite or aggregated semen analysis score will be calculated; each parameter will be reported separately as a standalone outcome.
Change in Sperm Concentration (million/mL)
Sperm concentration measured according to WHO 2021 semen analysis guidelines. This outcome will be analyzed and reported as an independent measure of semen quality. No composite or aggregated semen analysis score will be calculated; each parameter will be reported separately as a standalone outcome.
Change in Total Sperm Motility (%)
Percentage of motile spermatozoa (total motility) assessed according to WHO 2021 semen analysis guidelines. This outcome will be analyzed and reported as an independent measure of semen quality. No composite or aggregated semen analysis score will be calculated; each parameter will be reported separately as a standalone outcome.
Change in Progressive Sperm Motility (%)
Percentage of progressively motile spermatozoa assessed according to WHO 2021 semen analysis guidelines. This outcome will be analyzed and reported as an independent measure of semen quality. No composite or aggregated semen analysis score will be calculated; each parameter will be reported separately as a standalone outcome.
Change in Seminal Oxidative Stress Signal (Color Units, CU)
Seminal oxidative stress assessed using the OxiSperm II test based on a nitroblue tetrazolium (NBT) colorimetric reaction. The OXI II application provides a digital quantitative output expressed in Color Units (CU), ranging from 0 to 100 CU which will be reported as a continuous variable.
Adherence to Gazpacho Intake (%)
Percentage of planned gazpacho intakes completed during the 12-week intervention period, assessed using a self-administered compliance diary and scheduled follow-up phone calls.
Incidence of Treatment-Emergent Adverse Events
Number and type of adverse events reported by participants during the 12-week dietary intervention period, assessed through participant self-report and scheduled follow-up phone calls.
Biochemical Pregnancy Rate
Proportion of female partners with at least one positive serum or urinary hCG test during the follow-up period, calculated as the number of participants with a biochemical pregnancy divided by the total number of participants at risk.
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Ginefiv
Lead sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
Collaborator
