Effect of nut consumption on semen quality and functionality in healthy males
| ISRCTN | ISRCTN12857940 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12857940 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/05/2016
- Registration date
- 25/05/2016
- Last edited
- 09/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Human semen quality has declined in industrialized nations, with pollution, smoking, and trends toward a Western-style diet as possible causes. Although the importance of diet to human reproductive success is clear, existing dietary recommendations primarily focus on women’s reproductive health with less attention given to men. Because nuts have a considerable amount of several nutrients that are involved in male fertility, we believe that tree nut consumption added to a Western-style diet would improve semen quality and functionality. The aim of this study is to evaluate the effect of eating tree nuts on semen quality.
Who can participate?
Healthy men aged between 18 and 35
What does the study involve?
Participants are randomly allocated to one of two groups. One group continues to consume their usual diet supplemented with 60 g per day of a mixture of raw nuts. The other group continues to consume their usual diet, avoiding consumption of nuts. Blood and sperm samples are collected at the start of the study and after 14 weeks to assess sperm quality.
What are the possible benefits and risks of participating?
Participation in the study may help the participants to better understand their health. The information obtained may benefit other patients in the future and contribute to a better understanding of the effect of nut consumption on male fertility. There are no health risks involved in this study. The extraction of the blood sample can cause a burning sensation at the point where the needle is inserted and can cause a small bruise which disappears in a few days. More rarely it can cause transient dizziness.
Where is the study run from?
1. Universitat Autònoma de Barcelona (Spain)
2. Universitat Rovira i Virgili (Spain)
When is the study starting and how long is it expected to run for?
September 2015 to August 2017
Who is funding the study?
INC International Nut and Dried Fruit Council Foundation (Spain)
Who is the main contact?
Dr Mònica Bulló Bonet
monica.bullo@urv.cat
Contact information
Scientific
C/Sant Llorenç, 21
Reus
43201
Spain
 ORCID ID |
0000-0002-0218-7046 |
|---|---|
| Phone | +34 (0)977 75 93 13 |
| monica.bullo@urv.cat |
Study information
| Study design | Randomized 14-week parallel two-group dietary intervention trial with single-blind masking of outcome assessors |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effect of nut consumption on semen quality and functionality in a cohort of healthy males |
| Study acronym | FERTINUTS |
| Study objectives | Because nuts have a considerable amount of several nutrients that have been implicated in the modulation of several mechanism implicated in male fertility, we hypothesize that tree nut consumption added to a Western-style diet would beneficially affect semen quality and functionality. |
| Ethics approval(s) | Comitè d'Ètica d'Investigació Clínica (Hospital Universitari Sant Joan de Reus), 29/10/2015, Ref. CEIC: 15-10-29/10aclaassN1 |
| Health condition(s) or problem(s) studied | Semen quality and functionality |
| Intervention | Participants will be randomly assigned to one of two intervention groups for 14 weeks: 1. Continue to consume their usual diet supplemented with 60 g/day of a mixture of raw nuts. 2. Continue to consume their usual diet, avoiding consumption of nuts. |
| Intervention type | Supplement |
| Primary outcome measure | Improvement of sperm vitality and motility. Semen samples will be collected at baseline and the end of the intervention period. All men will be instructed to abstain for 3 days prior to providing the study specimen, with abstinence period verified by self-report on day of sample collection. Semen samples will be collected allowing analysis within 60 min of sample production. A single researcher, who was blinded as to intervention versus control group status, will perform the conventional semen analyses. For the rest of analysis aliquots of semen will be frozen at -196ºC until analysis. |
| Secondary outcome measures | Semen samples will be collected at baseline and the end of the intervention period: 1. Other conventional semen parameters 2. Plasma lipid profile, glucose and insulin concentrations 3. Serum folic acid and alpha-linolenic concentrations 4. Sperm DNA fragmentation 5. Sperm ROS evaluation 6. Sperm miRNA expression profiles 7. Sperm DNA methylation 8. Sperm chromosome stability |
| Overall study start date | 01/09/2015 |
| Completion date | 31/08/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 35 Years |
| Sex | Male |
| Target number of participants | 118 (69 in control group and 69 in intervention group) |
| Total final enrolment | 119 |
| Key inclusion criteria | 1. Healthy males 2. 18-35 years old 3. Reported a western-style diet |
| Key exclusion criteria | 1. Frequent consumption of nuts or a known history of allergy 2. Use of plant sterol or fish oil supplements and multivitamins, vitamin E or other antioxidant supplements 3. History of reproductive disorders or vasectomy 4. Current smokers 5. Taking antioxidant supplements or medications for chronic illness 6. Use of illegal drugs |
| Date of first enrolment | 02/12/2015 |
| Date of final enrolment | 30/09/2016 |
Locations
Countries of recruitment
- Spain
Study participating centres
Bellaterra (Cerdanyola del Vallès)
08193
Spain
Reus
43201
Spain
Sponsor information
Other
Carrer de la Fruita Seca 4
Polígon Tecnoparc
Reus
43204
Spain
| Phone | +34 (0)977 331 416 |
|---|---|
| irene.girones@nutfruit.org | |
| Website | www.nutfruit.org |
"ROR" |
https://ror.org/030wfqt16 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/01/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Impact for the scientific community and healthcare professionals The dissemination plan will include participation in the major scientific events in the knowledge area (nutrition and dietetics, and fertility) such as: International Congress on Nutrition (IUNS); European Congress on Nutrition (ECN); Congress of the Sociedad Española de Nutrición (SEN); European Society of Human Reproduction and Embriology (ESHRE) congress; Congress of the Asociación Española de Biología de la Reproducción (ASEBIR). Participation is also envisaged in specific congresses for primary care physicians such as the Spanish Society of Family Medicine and Community Congress (SemFYC). It is also expected to publish the results in the best journals of medicine, nutrition and dietetics, fertility, and genetics. Impact of the research on consumers The dissemination plan is designed for both health care and consumers, and it includes social media (participation in radio and television for the target audience in both national and international media), and Internet networks (website, Facebook, Twitter). An animated whiteboard video will be produced to target a non-scientific audience and help visualize the scientific background and results of the study. Impact on the industry The results will be communicated using media press releases, and the website platform and networks of the International Nut and Dried Fruits Foundation. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/11/2018 | Yes | No | ||
| Basic results | 29/11/2018 | 29/11/2018 | No | No | |
| Results article | 04/03/2019 | Yes | No | ||
| Results article | 19/06/2019 | 20/06/2019 | Yes | No | |
| Other publications | Cross-sectional and prospective analysis | 29/04/2024 | 09/06/2025 | Yes | No |
Additional files
- ISRCTN12857940_BasicResults_29Nov18.pdf
- Uploaded 29/11/2018
Editorial Notes
09/06/2025: Publication reference added.
20/06/2019: Publication reference and total final enrolment added.
06/03/2019: Publication reference added.
29/11/2018: The basic results of this trial have been uploaded as an additional file.
27/11/2018: Publication reference added.
