None listed
Conditions
Brief summary
Cognition and aggression were assessed during four phases of the menstrual cycle across one baseline cycle with no treatment, followed by two cycles with either 200 mg isoflavones daily or placebo. A comparison group of long term oral contraceptive users were also included and received only placebo during the treatment cycles. Brain activity was measured using electroencephalography (EEG) during the baseline and second treatment cycles.
Interventions
Capsule containing 200 mg isoflavones (SoyLife 40) taken once daily for two menstrual cycles. Participants were asked to return unused capsules at each study visit in order for compliance to be monitored.
Sponsors
Swinburne University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
Aged 18-35 Regular menstrual cycles Using no hormonal contraception for past 3 months (or using combined oral contraceptive pill for at least 3 months if in the positive control group) BMI between 19 and 26 Consume soy products less than 2 times per week Non-smoker Not seeking help for premenstrual syndrome Not pregnant or lactating No history of psychiatric disorders, anxiety or depression No neurological, gastrointestinal, endocrine or bleeding disorders No food allergies or intolerances
Exclusion criteria
Pregnant or lactating History of anxiety or depression Irregular menstrual cycles
Outcome results
None listed