Menopause
Conditions
Keywords
soya, menopause, cognitive function, isoflavones
Brief summary
Participants will be randomly assigned to one of three treatment groups to receive soyafoods (Alpro drinks) providing a low (\<10 mg), medium (35mg) or high-dose (60 mg) of isoflavones daily for a period of 12 weeks. The group receiving \<10mg isoflavones daily will serve as a low-dose control group. Women will be asked to avoid consuming any additional soya foods during the study. Dietary intake will be assessed at baseline using the validated food frequency questionnaire a 4 day food diary will be completed at baseline and post-intervention. Weight and height will be measured and a general health & lifestyle questionnaire will also be completed by participants at baseline. Cognitive function will be assessed at baseline and post-intervention using the well validated and widely used computerised test battery system. Menopausal symptoms, quality of life, mood, stress and coping will also be assessed. Plasma concentrations of the soya isoflavones genistein and daidzein will be measured to assess compliance. Circulating concentrations of equol (a daidzein metabolite), will also be measured to investigate associations between equol and cognition and menopausal symptoms as a potential mechanism for the efficacy of soya.
Interventions
DIETARY_SUPPLEMENTAlpro soya drinks
12 weeks
Sponsors
Alpro Foundation
University of Ulster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* apparently healthy * within 7 years postmenpopausal with the absence of vaginal bleeding for at least 1 year * ≥ 24 in mini mental state examination * not suffering from psychiatric distress as assessed using GHQ28 questionnaire
Exclusion criteria
* surgically induced menopause * habitual consumers of soys foods (\> 2 serves/week) * currently using hormone therapy * currently on isoflavone supplements * antibiotics use within last 3 months * use of psychoactive medication * history of CVD, cancer, diabetes, thyroid, renal or kidney disease, alcohol or drug abuse * red-green colour blindness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive function | Change at Week 12 from baseline | Assessed using the computerised Cambridge Neuropsychological Test Automated Battery (CANTAB) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Menopausal symptoms | Change at Week 12 from baseline | Greene's Climacteric scale, a 21 item scale measuring menopausal symptoms, including psychological, somatic and vasomotor symptoms, it is scored on a scale from 0-63, with higher scores indicating greater severity of symptoms. |
| Change in Quality of Life | Change at Week 12 from baseline | Control, Autonomy, Self-realisation and Pleasure (CASP-19). CASP 19 is a measure of quality of life, it has 19 questions comprising 4 subscales assessing control, autonomy, self-realisation and pleasure, scored from 0-3, subscales range from 0-12 and 0-15, with higher scores indicating higher quality of life. |
| Change in Mood | Change at Week 12 from baseline | Positive and Negative Affect Schedule (PANAS), a 20 item questionnaire assessing positive and negative mood, a score is calculated for each of these and range from 1-50, with higher scores indicating greater presence of the mood. |
| Change in Stress | Change at Week 12 from baseline | Perceived stress scale, a 14 item questionnaire measuring global stress levels with a higher score indicating greater psychological distress. Scores can range from 0-52. |
| Change in Coping | Change at Week 12 from baseline | COPE Inventory |
Countries
United Kingdom
Outcome results
None listed