Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000930583
Ethics application status
Approved
Date submitted
4/08/2015
Date registered
7/09/2015
Date last updated
12/09/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Chronic effects of isoflavones on cognition and aggression in a female population across the menstrual cycle.
Scientific title
Chronic effects of isoflavones (SoyLife 40) on cognition and aggression in a female population across the menstrual cycle.
Secondary ID [1] 287219 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function 295816 0
Premenstrual syndrome 295817 0
Aggression 295818 0
Mood 295819 0
Condition category
Condition code
Alternative and Complementary Medicine 296076 296076 0 0
Other alternative and complementary medicine
Mental Health 296077 296077 0 0
Studies of normal psychology, cognitive function and behaviour
Reproductive Health and Childbirth 296078 296078 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 292505 0
Treatment: Other
Comparator / control treatment
Placebo capsule containing maltodextrin.
If in the positive control group of oral contraceptive users, any monophasic combined oral contraceptive could be used as long as it had been used for at least 3 months prior to entering the study. Contraceptive pill users were assigned placebo only due to the possibility of active treatment reducing efficacy of contraception.
Control group
Placebo

Outcomes
Primary outcome [1] 295754 0
Aggression measured using the Buss-Perry Aggression Questionnaire (BPAQ).
Timepoint [1] 295754 0
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:
Cycle day = (day of cycle/total no. days of cycle) x 28.
Secondary outcome [1] 316411 0
Cognitive function assessed using the COMPASS cognitive testing battery. The domains of working memory, executive function, secondary memory, attention and reaction time were assessed using the following tasks: immediate and delayed word recall; word recognition; picture recognition; corsi blocks forward and reversed; N-back; alphabetic and numeric working memory; simple, choice and four choice reaction time; sentence verification; peg and ball; card sorting; rapid visual information processing (RVIP); serial subtractions.
Timepoint [1] 316411 0
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:
Cycle day = (day of cycle/total no. days of cycle) x 28.
Secondary outcome [2] 316547 0
Aggression measured using the state-trait anger expression inventory (STAXI) and an emotional Stroop task.
Timepoint [2] 316547 0
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:
Cycle day = (day of cycle/total no. days of cycle) x 28.
Secondary outcome [3] 316548 0
Brain electrical activity during a standard and an emotional go/no-go task measured using electroencephalography (EEG).
Timepoint [3] 316548 0
During menses and the luteal phase of the baseline and second treatment cycle on any of the days included in that phase: menses (days 1-5); luteal (days 20-26).
Secondary outcome [4] 317166 0
General mood measured using the Profile of Mood States.
Timepoint [4] 317166 0
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:
Cycle day = (day of cycle/total no. days of cycle) x 28.
Secondary outcome [5] 317167 0
Depression measured using the Beck Depression Inventory.
Timepoint [5] 317167 0
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:
Cycle day = (day of cycle/total no. days of cycle) x 28.
Secondary outcome [6] 317168 0
Impulsivity measured using the Barratt Impulsiveness Scale.
Timepoint [6] 317168 0
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:
Cycle day = (day of cycle/total no. days of cycle) x 28.
Secondary outcome [7] 317169 0
Premenstrual symptoms measured using the Revised Daily Symptom Report (DSR-20).
Timepoint [7] 317169 0
Daily for two menstrual cycles following a baseline cycle.
Secondary outcome [8] 317170 0
Anxiety measured using the State-Trait Anxiety Inventory.
Timepoint [8] 317170 0
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:
Cycle day = (day of cycle/total no. days of cycle) x 28.
Secondary outcome [9] 317171 0
Schizotypal personality traits measured using the Schizotypal Personality Questionnaire.
Timepoint [9] 317171 0
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:
Cycle day = (day of cycle/total no. days of cycle) x 28.
Secondary outcome [10] 317172 0
General physical and psychological symptoms measured using the Symptom Checklist.
Timepoint [10] 317172 0
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:
Cycle day = (day of cycle/total no. days of cycle) x 28.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnant or lactating
History of anxiety or depression
Irregular menstrual cycles

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects were assessed for eligibility during a screening visit where they gave informed consent. Following screening, assessments were taken four times during a baseline menstrual cycle (approximately once weekly) before being given treatment. Subjects were allocated to treatment by a third party.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Latin square.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Contraceptive pill users were assigned placebo only due to the possibility of active treatment reducing efficacy of contraception. This was known to both researcher and participants. Those not using contraception were randomly allocated to receive either soy isoflavones or placebo in a double blind fashion.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed models in SPSS version 21.0. As this was a novel study an a priori power calculation could not be perfomed. Sample size was estimated based on other studies of premenstrual syndrome where significant effects were reported. No sample size calculations were performed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/01/2011
Date of last participant enrolment
Anticipated
Actual
7/12/2012
Date of last data collection
Anticipated
Actual
12/04/2013
Sample size
Target
90
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291790 0
Commercial sector/Industry
Name [1] 291790 0
Frutarom Ltd.
Country [1] 291790 0
Israel
Funding source category [2] 291820 0
University
Name [2] 291820 0
Swinburne University of Technology
Country [2] 291820 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
PO Box 218
Hawthorn
Victoria
3122
Country
Australia
Secondary sponsor category [1] 290452 0
None
Name [1] 290452 0
Address [1] 290452 0
Country [1] 290452 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293308 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 293308 0
Ethics committee country [1] 293308 0
Australia
Date submitted for ethics approval [1] 293308 0
Approval date [1] 293308 0
27/08/2010
Ethics approval number [1] 293308 0
2009/224

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59326 0
Prof Andrew Scholey
Address 59326 0
ATC1040
Swinburne University
427-451 Burwood Road
Hawthorn
VIC 3122
Country 59326 0
Australia
Phone 59326 0
+61392148932
Fax 59326 0
Email 59326 0
[email protected]
Contact person for public queries
Name 59327 0
Naomi Perry
Address 59327 0
Swinburne University
427-451 Burwood Rd
Hawthorn
VIC 3122
Country 59327 0
Australia
Phone 59327 0
+61392144915
Fax 59327 0
Email 59327 0
[email protected]
Contact person for scientific queries
Name 59328 0
Naomi Perry
Address 59328 0
Swinburne University
427-451 Burwood Road
Hawthorn
VIC 3122
Country 59328 0
Australia
Phone 59328 0
+61392144915
Fax 59328 0
Email 59328 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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