The Effect of Soya Foods on Cognitive Function and Menopausal Symptoms in Postmenopausal Women.

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Soya Foods on Cognitive Function and Menopausal Symptoms in Postmenopausal Women.

Conditions
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Menopause

Intervention / Treatment
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* Dietary Supplement: Alpro soya drinks


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low isoflavone<br>Alpro soya drinks containing 10 mg isoflavones per day | Dietary Supplement: Alpro soya drinks<br>* 12 weeks<br>|
| Active Comparator: Medium isoflavone<br>Alpro soya drinks containing 35 mg isoflavones per day | Dietary Supplement: Alpro soya drinks<br>* 12 weeks<br>|
| Active Comparator: High isoflavone<br>Alpro soya drinks containing 60 mg isoflavones per day | Dietary Supplement: Alpro soya drinks<br>* 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cognitive function | Assessed using the computerised Cambridge Neuropsychological Test Automated Battery (CANTAB) | Change at Week 12 from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Menopausal symptoms | 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 at Week 12 from baseline | 
| Change in Quality of Life | 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 at Week 12 from baseline | 
| Change in Mood | 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 at Week 12 from baseline | 
| Change in Stress | 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 at Week 12 from baseline | 
| Change in Coping | COPE Inventory | Change at Week 12 from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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soya, menopause, cognitive function, isoflavones