Effect of nut consumption on semen quality and functionality in healthy males
| ISRCTN | ISRCTN12857940 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12857940 |
| Protocol serial number | N/A |
| Sponsor | INC International Nut and Dried Fruit Council Foundation (Spain) |
| Funder | INC International Nut and Dried Fruit Council Foundation (Spain) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomized 14-week parallel two-group dietary intervention trial with single-blind masking of outcome assessors |
| Secondary study design | Randomised parallel trial |
| Study type | 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(s) |
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. |
| Key secondary outcome measure(s) |
Semen samples will be collected at baseline and the end of the intervention period: |
| 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 sample size at registration | 118 |
| 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
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/11/2018 | Yes | No | ||
| Results article | 04/03/2019 | Yes | No | ||
| Results article | 19/06/2019 | 20/06/2019 | Yes | No | |
| Basic results | 29/11/2018 | 29/11/2018 | No | No | |
| Other publications | Cross-sectional and prospective analysis | 29/04/2024 | 09/06/2025 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
