NCT03561662

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2015

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2018

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
Last Updated

June 19, 2018

Status Verified

May 1, 2018

Enrollment Period

3 years

First QC Date

May 2, 2018

Last Update Submit

June 18, 2018

Conditions

Menopause

Keywords

soyamenopausecognitive functionisoflavones

Outcome Measures

Primary Outcomes (1)

  • Change in Cognitive function

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

    Change at Week 12 from baseline

Secondary Outcomes (5)

  • Change in Menopausal symptoms

    Change at Week 12 from baseline

  • Change in Quality of Life

    Change at Week 12 from baseline

  • Change in Mood

    Change at Week 12 from baseline

  • Change in Stress

    Change at Week 12 from baseline

  • Change in Coping

    Change at Week 12 from baseline

Study Arms (3)

Low isoflavone

ACTIVE COMPARATOR

Alpro soya drinks containing 10 mg isoflavones per day

Dietary Supplement: Alpro soya drinks

Medium isoflavone

ACTIVE COMPARATOR

Alpro soya drinks containing 35 mg isoflavones per day

Dietary Supplement: Alpro soya drinks

High isoflavone

ACTIVE COMPARATOR

Alpro soya drinks containing 60 mg isoflavones per day

Dietary Supplement: Alpro soya drinks

Interventions

Alpro soya drinksDIETARY_SUPPLEMENT

12 weeks

High isoflavoneLow isoflavoneMedium isoflavone

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Intervention Studies Unit, Ulster University

Coleraine, Co.Londonderry, BT52 1SA, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2018

First Posted

June 19, 2018

Study Start

May 14, 2015

Primary Completion

May 14, 2018

Study Completion

May 14, 2018

Last Updated

June 19, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)