NCT07375238

Effect of Daily Intake of Gazpacho on Semen Quality and Oxidative Stress

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Ginefiv · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Detailed description

Detailed Description This is a single-center, prospective, randomized, open-label, parallel-group study conducted at GINEFIV (IVIRMA Madrid). Eligible participants are men aged 18-45 years with an andrological profile that includes altered semen parameters such as oligozoospermia with or without associated asthenozoospermia and/or teratozoospermia (O±A±T). Participants will be randomized in a 1:1 ratio to a control group following a standardized Mediterranean diet or an intervention group following the same diet with the addition of 330 mL per day of commercially available gazpacho. The intervention period lasts 12 weeks. Participants in the intervention group will consume gazpacho once daily with a main meal. Two production batches of the product will be analyzed to determine lycopene, vitamin C, and vitamin E content. Adherence to the intervention will be evaluated using a self-administered compliance diary and scheduled follow-up phone calls. Semen samples will be collected at baseline and at the end of the intervention period. Semen analysis will be performed according to World Health Organization (WHO) 2021 guidelines. Seminal oxidative stress will be assessed using the OxiSperm II test and its Research Use Only (RUO) digital application, which will not be used for clinical decision-making. The primary objective of the study is to evaluate changes in semen quality following the intervention. Secondary objectives include the assessment of seminal oxidative stress, adherence to the dietary intervention, safety and tolerability, and reproductive outcomes collected during post-intervention follow-up. Participants will be followed for 18 months after completion of the intervention to record reproductive outcomes. The total study duration is estimated at 54 months, including recruitment, intervention, follow-up, and data analysis periods.

Conditions

• Male Infertility
• Oxidative Stress
• Subfertility
• Oligozoospermia
• Asthenozoospermia
• Teratozoospermia

Interventions

Type	Name	Description
OTHER	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.
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2026-03-02
• Primary completion: 2028-03-01
• Completion: 2029-09-01
• First posted: 2026-01-29
• Last updated: 2026-03-13

Locations

1 site across 1 country: Spain