Effect of lactolycopene on sperm health Urological and Genital Diseases
Conditions
Interventions
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
Sponsors
The University of Sheffield (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy males 2. Age 18-30
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Motile sperm concentration - assessed at week 0 (baseline), week 6 (interim) and week 12 (end of intervention) according to WHO (2010) methods | — |
Secondary
| Measure | Time frame |
|---|---|
| 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/) | — |
Countries
United Kingdom
Outcome results
None listed