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OpenTrials
Completed

NCT Number: NCT03561662

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

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.

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Key information

Conditions

Menopause

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Human Intervention Studies Unit, Ulster University

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alpro soya drinks

Dietary Supplement

12 weeks

Primary outcomes

  1. Change in Cognitive function

    Time frame: Change at Week 12 from baseline

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

Secondary outcomes

  1. Change in Menopausal symptoms

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Change at Week 12 from baseline

    COPE Inventory

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Collaborators

  • Alpro Foundation

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 19, 2018
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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