Male InfertilityOxidative StressSubfertilityOligozoospermiaAsthenozoospermiaTeratozoospermia
Investigational drug(s) / intervention(s)
Standardized Mediterranean DietGazpacho
Standardized Mediterranean Diet: Participants 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: Participants 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.
Study summary
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
Eligibility
Sex
MALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
* Signed and dated written informed consent form
Exclusion Criteria:
* 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.
* Known allergy or intolerance to any ingredient of the gazpacho used in the study.
* Any medical, psychological or social condition that, in the investigator's judgement, could compromise the subject's ability to participate fully or comply with the protocol requirements.
* Simultaneous participation in another clinical study.
Primary outcome measure(s)
Change in Ejaculate Volume (mL) — Baseline to 12 weeks 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) — Baseline to 12 weeks 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 (%) — Baseline to 12 weeks 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 (%) — Baseline to 12 weeks 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 Normal Sperm Morphology (%) — Baseline to 12 weeks Percentage of spermatozoa with normal morphology assessed according to WHO 2021 criteria. 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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