An interventional study of Alpro soya drinks in Menopause, sponsored by University of Ulster. Completed at 1 site in United Kingdom. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-19.
Sponsored by University of Ulster · Not applicable, Interventional, and Treatment
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.
University of Ulster is the lead sponsor of 94 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Alpro soya drinks containing 10 mg isoflavones per day
Dietary Supplement: Alpro soya drinks
Alpro soya drinks containing 35 mg isoflavones per day
Dietary Supplement: Alpro soya drinks
Alpro soya drinks containing 60 mg isoflavones per day
Dietary Supplement: Alpro soya drinks
12 weeks
Change in Cognitive function
Assessed using the computerised Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: Change at Week 12 from baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change at Week 12 from baseline
Change in Coping
COPE Inventory
Time frame: Change at Week 12 from baseline
Plan to share: No
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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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University of Ulster