Ignite Creation Date:
2024-05-06 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03561662
Status:
COMPLETED
Last Update Posted:
2018-06-19
First Post:
2018-05-02
Brief Title:
The Effect of Soya Foods on Cognitive Function and Menopausal Symptoms in Postmenopausal Women
Sponsor:
University of Ulster
Organization:
University of Ulster
Study Overview
Official Title:
The Effect of Soya Foods on Cognitive Function and Menopausal Symptoms in Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None