Condition category
Urological and Genital Diseases
Date applied
10/06/2016
Date assigned
16/06/2016
Last edited
16/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Liz Williams

ORCID ID

http://orcid.org/0000-0002-1431-7549

Contact details

Department of Oncology & Metabolism
Beech Hill Road
Sheffield
S10 2RX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

147769

Study information

Scientific title

The effect of lactolycopene on sperm quality in healthy men - a pilot study

Acronym

TomsTrial

Study hypothesis

It is hypothesised that dietary supplementation with lactolycopene will improve semen quality in healthy males.

Ethics approval

Medical School, University of Sheffield Research Ethics Committee, 22/03/2016, Ref: 008135

Study design

12-week double-blind randomised placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Reproductive health, nutritional

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

Phase

Drug names

Primary outcome measures

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 trial start date

11/04/2016

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy males
2. Age 18-30


Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

60

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

Trial participating centre

The University of Sheffield
Department of Oncology & Metabolism Beech Hill Road
Sheffield
S10 2RX
United States of America

Sponsor information

Organisation

The University of Sheffield (UK)

Sponsor details

Research & Innovation Services
New Spring House
231 Glossop Road
Sheffield
S10 2GW
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Sheffield

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Funder name

Cambridge Nutraceuticals Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes