NCT03561662

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

Completed NA Last updated 19 June 2018

What this trial tests

NA trial testing Alpro soya drinks in Menopause in 117 participants. Completed in 14 May 2018.

Timeline

14 May 2015

Primary endpoint
14 May 2018

14 May 2018

Quick facts

Lead sponsor	University of Ulster
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	117
Start date	14 May 2015
Primary completion	14 May 2018
Estimated completion	14 May 2018
Sites	1 location across United Kingdom

Drugs / interventions tested

• Alpro soya drinks

Conditions studied

• Menopause — all drugs for Menopause →

Sponsor

University of Ulster

Who can join

Eligibility, female only, with Menopause. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Consumption of a soy drink has no effect on cognitive function but may alleviate vasomotor symptoms in post-menopausal women; a randomised trial.
   Furlong ON, Parr HJ, Hodge SJ, Slevin MM, et al · · 2020 · cited 16× · PMID 30863894 · DOI 10.1007/s00394-019-01942-5