Daily gazpacho to improve semen quality in men with reduced sperm parameters

Effect of Daily Intake of Gazpacho on Semen Quality and Oxidative Stress in Men With Altered Semen Parameters: A Randomized Controlled Study

This study will test whether drinking a daily 330 mL serving of gazpacho for 12 weeks helps men with reduced sperm quality improve their semen parameters and lower oxidative stress.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Male
• Sponsor: Ginefiv (other)
• Locations: 1 site (Madrid, Madrid)
• Trial ID: NCT07375238 on ClinicalTrials.gov

What this trial studies

This is a single-center, randomized, open-label trial at GINEFIV (IVIRMA Madrid) comparing a standardized Mediterranean diet alone versus the same diet plus a daily 330 mL gazpacho for 12 weeks in men aged 18–45 with altered semen parameters. Participants are randomized 1:1 and provide semen samples at baseline and after 12 weeks; semen analysis follows WHO 2021 guidelines. Seminal oxidative stress will be measured with the OxiSperm II test (research use only) and two production batches of the gazpacho product will be analyzed for lycopene, vitamin C, and vitamin E. Adherence is tracked with a self-administered diary and scheduled follow-up calls.

Who should consider this trial

Good fit: Ideal candidates are men 18–45 years old with oligozoospermia and/or asthenozoospermia or teratozoospermia who can follow a standardized Mediterranean diet and consent to study procedures.

Not a fit: Men with azoospermia, leucocytospermia, necrozoospermia, active smokers, recent antioxidant supplement use, severe systemic disease, or known allergy to gazpacho ingredients are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, adding daily gazpacho could provide a simple, food-based way to improve sperm quality and reduce oxidative stress in men with altered semen parameters.

How similar studies have performed: Previous studies suggest Mediterranean-style diets and antioxidant-rich foods can modestly improve sperm parameters, but daily gazpacho as a specific intervention is relatively novel and not well studied.

Eligibility criteria

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.

Where this trial is running

Madrid, Madrid

• GINEFIV Madrid (IVIRMA Group) — Madrid, Madrid, Spain (RECRUITING)

Study contacts

• Principal investigator: Pablo Martí Pastor, RD, RND — Ginefiv Madrid (IVIRMA Group)
• Study coordinator: Pablo Martí Pastor, RN, RDN

Conditions: Male Infertility, Oxidative Stress, Subfertility, Oligozoospermia, Asthenozoospermia, Teratozoospermia, Mediterranean diet, Gazpacho