The Effect of Soya Foods on Cognitive Function and Menopausal Symptoms in Postmenopausal Women.
NCT ID: NCT03561662
Last Updated: 2018-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
117 participants
INTERVENTIONAL
2015-05-14
2018-05-14
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low isoflavone
Alpro soya drinks containing 10 mg isoflavones per day
Alpro soya drinks
12 weeks
Medium isoflavone
Alpro soya drinks containing 35 mg isoflavones per day
Alpro soya drinks
12 weeks
High isoflavone
Alpro soya drinks containing 60 mg isoflavones per day
Alpro soya drinks
12 weeks
Interventions
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Alpro soya drinks
12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
FEMALE
Yes
Sponsors
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Alpro Foundation
OTHER
University of Ulster
OTHER
Responsible Party
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Locations
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Human Intervention Studies Unit, Ulster University
Coleraine, Co.Londonderry, United Kingdom
Countries
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Other Identifiers
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UREC/15/0025
Identifier Type: -
Identifier Source: org_study_id
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