NCT03561662

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: University of Ulster · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Menopause

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Alpro soya drinks	12 weeks

Timeline

• Start date: 2015-05-14
• Primary completion: 2018-05-14
• Completion: 2018-05-14
• First posted: 2018-06-19
• Last updated: 2018-06-19

Locations

1 site across 1 country: United Kingdom