The study is a 2-armed, comparator controlled, double-blinded study. Subjects, study
staff, sperm quality assessor and statistician will be blinded to the nutritional
intervention.
The study Sponsor will be unblinded for purposes of packaging and supply of nutritional
products.
Screening (Visit 0). Subjects will be asked to join the study based on an analysis
documenting poor semen quality. Subjects will be informed about the result of the semen
analysis and informed that the clinic is participating in a study about sperm quality.
Subjects that show interest to participate will be verbally and in writing given further
information about the study and the study procedures by dedicated study personnel.
Patients willing to sign the consent will have the possibility to ask further questions.
The clinic will provide a screening log with restricted access, containing screening
number and subject identification.
Enrolment (Visit 1). For eligible subjects, the study coordinator will take the consent
on behalf of the clinic.
Subjects who satisfy all inclusion criteria and no exclusion criteria will be randomised
to investigational product or comparator and given a randomisation number and will
receive enough capsules for 12 weeks. The clinic will provide a randomization log with
non-identifiable information.
Telephone follow-up (Visit 2). After 6 weeks (± 1 week), a dedicated study nurse will
contact the subject by phone. During the call, subjects will be asked about their
well-being, whether they have been consistently taking their capsules, and if they are
experiencing any issues that may be related to the study product.
Final Visit (Visit 3). 12 weeks (± 1 week) after the study commencement, the subject will
attend a follow-up physical visit and return any remaining capsules.
Subjects will be examined for vital signs, physical examination, relevant medical
history, current medications, smoking and alcohol habits and a food frequency
questionnaire. A period of abstinence (2 days) will be requested prior to study specific
sperm samples.
Each subject will take 2 x 1.0g capsules of EVOLVE 05 daily for 3 months or 2 x 1.0g
comparator capsules.
Sperm samples for quality measurements will be taken at visit 1 and visit 3. The
remaining sample will be frozen and maintained for analysis of VLCFA content.
Dietary intake will be recorded to control for marine specific dietary variables:
Assessment at visit 1 and visit 3 using a brief questionnaire.