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

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03561662
• Other study ID #: UREC/15/0025
• Status: Completed
• Phase: N/A
• Start date: May 14, 2015
• Est. completion date: May 14, 2018

Study information

• Verified date: May 2018
• Source: University of Ulster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: May 14, 2018
• Est. primary completion date: May 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• apparently healthy

• 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:

• surgically induced menopause

• 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

Related Conditions & MeSH terms

• Menopause

Intervention

Dietary Supplement:
• Alpro soya drinks
12 weeks

Locations

Country	Name	City	State
United Kingdom	Human Intervention Studies Unit, Ulster University	Coleraine	Co.Londonderry

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulster	Alpro Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cognitive function	Assessed using the computerised Cambridge Neuropsychological Test Automated Battery (CANTAB)	Change at Week 12 from baseline
Secondary	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.	Change at Week 12 from baseline
Secondary	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.	Change at Week 12 from baseline
Secondary	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.	Change at Week 12 from baseline
Secondary	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.	Change at Week 12 from baseline
Secondary	Change in Coping	COPE Inventory	Change at Week 12 from baseline