Effect of Daily Intake of Gazpacho on Semen Quality and Oxidative Stress in Men With Altered Semen Parameters: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Ejaculate Volume (mL)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study. Due to the nature of the dietary intervention, masking of participants and care providers is not feasible. Laboratory personnel performing semen analysis and oxidative stress assessments are not involved in the allocation process and are blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Standardized Mediterranean Diet Alone (Control)
Participants will follow a standardized Mediterranean diet for a period of 12 weeks. Adherence to the dietary recommendations will be monitored using a self-administered compliance diary and scheduled follow-up phone calls.
干预措施: Standardized Mediterranean Diet (Other)
Gazpacho + Standardized Mediterranean Diet (Intervention)
Participants assigned to the intervention arm will follow a standardized Mediterranean diet for 12 weeks and will additionally consume 330 mL of commercially available gazpacho once daily with a main meal. Adherence to the intervention will be monitored using a self-administered compliance diary and scheduled follow-up phone calls.
干预措施: Standardized Mediterranean Diet (Other)
Gazpacho + Standardized Mediterranean Diet (Intervention)
Participants assigned to the intervention arm will follow a standardized Mediterranean diet for 12 weeks and will additionally consume 330 mL of commercially available gazpacho once daily with a main meal. Adherence to the intervention will be monitored using a self-administered compliance diary and scheduled follow-up phone calls.
干预措施: Gazpacho (Dietary Supplement)
结局指标
主要结局
Change in Ejaculate Volume (mL)
时间窗: 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)
时间窗: 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 (%)
时间窗: 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 (%)
时间窗: 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 (%)
时间窗: 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.
次要结局
- Change in Seminal Oxidative Stress Signal (Color Units, CU)(Baseline to 12 weeks)
- Adherence to Gazpacho Intake (%)(Baseline to12 weeks)
- Incidence of Treatment-Emergent Adverse Events(Baseline to 12 weeks)
- Biochemical Pregnancy Rate(Up to 18 months post-intervention)
- Clinical Pregnancy Rate(Up to 18 months post-intervention)
- Miscarriage Rate(Up to 18 months post-intervention)
- Live Birth Rate(Up to 18 months post-intervention)
研究者
Pablo Martí
Nurse and Dietitian-Nutritionist (Assisted Reproduction)
Ginefiv