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

• Sponsor: University of Ulster (Other)
• Overall Status: Completed
• CT.gov ID: NCT03561662
• Collaborator: Alpro Foundation (Other)
• Enrollment: 117
• Location: 1
• Arms: 3
• Actual Duration (Months): 36
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menopause	Dietary Supplement: Alpro soya drinks	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 117 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Soya Foods on Cognitive Function and Menopausal Symptoms in Postmenopausal Women.
• Actual Study Start Date: May 14, 2015
• Actual Primary Completion Date: May 14, 2018
• Actual Study Completion Date: May 14, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Low isoflavone Alpro soya drinks containing 10 mg isoflavones per day	Dietary Supplement: Alpro soya drinks; 12 weeks
Active Comparator: Medium isoflavone Alpro soya drinks containing 35 mg isoflavones per day	Dietary Supplement: Alpro soya drinks; 12 weeks
Active Comparator: High isoflavone Alpro soya drinks containing 60 mg isoflavones per day	Dietary Supplement: Alpro soya drinks; 12 weeks

Outcome Measures

Primary Outcome Measures

1. Change in Cognitive function [Change at Week 12 from baseline]

   Assessed using the computerised Cambridge Neuropsychological Test Automated Battery (CANTAB)

Secondary Outcome Measures

1. Change in Menopausal symptoms [Change at Week 12 from baseline]

   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.

2. Change in Quality of Life [Change at Week 12 from baseline]

   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.

3. Change in Mood [Change at Week 12 from baseline]

   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.

4. Change in Stress [Change at Week 12 from baseline]

   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.

5. Change in Coping [Change at Week 12 from baseline]

   COPE Inventory

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Human Intervention Studies Unit, Ulster University	Coleraine	Co.Londonderry	United Kingdom	BT52 1SA

Sponsors and Collaborators

• University of Ulster
• Alpro Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Ulster
• ClinicalTrials.gov Identifier: NCT03561662
• Other Study ID Numbers: UREC/15/0025
• First Posted: Jun 19, 2018
• Last Update Posted: Jun 19, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Ulster: soya; menopause; cognitive function; isoflavones

Study Results

No Results Posted as of Jun 19, 2018