Chronic effects of isoflavones on cognition and aggression in a female population across the menstrual cycle.

Not Applicable

Completed

• Conditions: Cognitive function; Premenstrual syndrome; Aggression; Mood; Alternative and Complementary Medicine - Other alternative and complementary medicine; Mental Health - Studies of normal psychology, cognitive function and behaviour; Reproductive Health and Childbirth - Menstruation and menopause

• Registration Number: ACTRN12615000930583
• Lead Sponsor: Swinburne University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aggression measured using the Buss-Perry Aggression Questionnaire (BPAQ).[Across four phases of the menstrual cycle on any of the days included in that phase: menses (days 1-5), follicular phase (days 6-11), ovulatory phase (days 12-16), luteal phase (days 20-26) over two consecutive menstrual cycles, following a baseline cycle. Phase timings were calculated based on a 28 day cycle, where participants did not have a 28 day cycle the following formula was applied to estimate cycle phase:<br>Cycle day = (day of cycle/total no. days of cycle) x 28.]