The effect of lycopene on semen quality in healthy men
| ISRCTN | ISRCTN33248724 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33248724 |
| Secondary identifying numbers | 147769 |
- Submission date
- 10/06/2016
- Registration date
- 16/06/2016
- Last edited
- 10/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Lycopene is a naturally occurring carotenoid (nutritional compound) found in a number of foods, such as tomatoes, watermelon and pink grapefruit. Lycopene has antioxidant properties and can protect against damage to cells. Studies have shown that lycopene reduces the risk of prostate cancer and is thought to have more general benefits to men’s health including sperm quality. This study aims to investigate the effect of lactolycopene on semen quality in healthy men.
Who can participate?
Healthy male volunteers between the ages of 18-30
What does the study involve?
Participants are invited to attend the Clinical Research Facility, Royal Hallamshire Hospital, Sheffield on three occasions (week 0, 6 and 12). On each occasion they are asked to produce a semen sample at home (after three days of sexual abstinence) to bring with them to the clinic. At the clinic, a blood sample is collected from each volunteer to analyse blood levels of lycopene. At the start of the study data is collected on weight, height, diet, smoking and type of underwear worn. At the 1st visit participants are randomly allocated to receive either a placebo (dummy) tablet or lactolycopene in capsule form and are instructed to consume the capsules twice daily for 12 weeks while following their normal diet. The lactolycopene supplement is a commercially available product available from a range of UK retailers and pharmacists. The supplement is manufactured by Cambridge Nutraceuticals Ltd., UK who are providing the supplement and the placebo for this study. Participants are asked to provide semen and blood samples at the start of the study, week 6 and at the end of the intervention (week 12). Each semen sample is examined for sperm volume, concentration, sperm motility (movement) and morphology (shape). Damage to the DNA of the sperm is also assessed. Blood samples are used to analyse blood lycopene levels as a marker of compliance to the intervention. Participants' diet is analysed at the start of the study and in the final week of intervention using nutritional software. No information is passed back to the donors about semen quality. Participants are reimbursed £25 per clinic visit to compensate them for their time and to cover any travel expenses.
What are the possible benefits & risks of participating?
Participants gain no direct benefit from involvement in the study, but it is hoped that the study will increase our understanding of the relationship between diet and sperm quality. We hope that in future this knowledge will help us with the treatment of male infertility. Blood samples are taken by an experienced phlebotomist in the Clinical Research Facility of a major teaching hospital. Participants may experience some bruising as a result of having the blood sample taken, but we do not anticipate any other risks.
Where is the study run from?
The project will be carried out in the Academic Unit of Reproductive and Developmental Medicine and the Human Nutrition Unit, Department of Oncology and Metabolism, The University of Sheffield, UK. Face to face contact with volunteers will be within the Clinical Research Facility of the Royal Hallamshire Hospital, Sheffield, UK.
Who is funding the study?
The study is self-funded from the University of Sheffield and is being run as part of postgraduate student research projects. Cambridge Nutraceuticals Ltd will supply the supplement and placebo in kind and will also provide participant compensation.
When is the study starting and how long is it expected to run for?
April 2016 to December 2016
Who is the main contact?
Dr Liz Williams
e.a.williams@sheffield.ac.uk
Contact information
Scientific
Department of Oncology & Metabolism
Beech Hill Road
Sheffield
S10 2RX
United Kingdom
 ORCID ID |
0000-0002-1431-7549 |
|---|
Study information
| Study design | 12-week double-blind randomised placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The effect of lactolycopene on sperm quality in healthy men - a pilot study |
| Study acronym | TomsTrial |
| Study hypothesis | It is hypothesised that dietary supplementation with lactolycopene will improve semen quality in healthy males. |
| Ethics approval(s) | Medical School, University of Sheffield Research Ethics Committee, 22/03/2016, Ref: 008135 |
| Condition | Effect of lactolycopene on sperm health |
| Intervention | Participants are randomised to receive either twice daily supplementation with 7mg lactolycopene (i.e. 14mg/d) or a placebo of identically packaged microcrystalline cellulose, twice daily for 12 weeks. Participants are block randomised in blocks of 6. |
| Intervention type | Supplement |
| Primary outcome measure | Motile sperm concentration - assessed at week 0 (baseline), week 6 (interim) and week 12 (end of intervention) according to WHO (2010) methods |
| Secondary outcome measures | 1. Sperm volume, sperm concentration, sperm motility and sperm morphology - analysed according to WHO (2010) methods 2. Sperm DNA fragmentation analysed using the TUNEL assay (Sharma et al. 2013) 3. Sperm DNA fragmentation analysed using the sperm chromatin dispersion test (Fernandez et al. 2003) 4. Plasma lycopene measured by HPLC (Thurnham et al. 1988) The above outcomes will be measured at week 0 (baseline), week 6 (interim) and week 12 (end of intervention) 5. Dietary intake - measured using an 4-day estimated food diary at week 0 and during week 12 and analysed using WinDiets dietary analysis software 6. Habitual dietary intake - assessed at baseline only - using EPIC food frequency questionnaire, and analysed using FETA-EPIC software (http://www.epic-norfolk.org.uk/) |
| Overall study start date | 11/04/2016 |
| Overall study end date | 31/12/2016 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 30 Years |
| Sex | Male |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Participant inclusion criteria | 1. Healthy males 2. Age 18-30 |
| Participant exclusion criteria | 1. Previous testicular surgery 2. Treatment for cancer 3. Current consumption of lycopene supplements 4. Allergy to tomato, whey protein or soy derivatives |
| Recruitment start date | 29/04/2016 |
| Recruitment end date | 01/10/2016 |
Locations
Countries of recruitment
- United Kingdom
- United States of America
Study participating centre
Beech Hill Road
Sheffield
S10 2RX
United States of America
Sponsor information
University/education
Research & Innovation Services
New Spring House
231 Glossop Road
Sheffield
S10 2GW
England
United Kingdom
"ROR" |
https://ror.org/05krs5044 |
|---|
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- sheffielduni, University of Sheffield UK, theuniversityofsheffield, University of Sheffield in United Kingdom, University of Sheffield, UK, The University of Sheffield, Sheffield University
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 31/07/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2020 | 10/10/2019 | Yes | No |
Editorial Notes
10/10/2019: The following changes were made:
1. Publication reference added.
2. The final enrolment number was added from the reference.
23/01/2019: The intention to publish date has been changed from 31/12/2017 to 31/07/2019
12/10/2017: internal review.
