MenopauseNCT03561662
The Effect of Soya Foods on Cognitive Function and Menopausal Symptoms in Postmenopausal Women.
A study testing Alpro soya drinks in people with Menopause, run by University of Ulster at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Alpro soya drinks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 May 2015to 14 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Intervention Studies Unit, Ulster University
Coleraine, Co.Londonderry, BT52 1SA
About this study
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.
- Conditions
- Menopause
- Being tested
- Alpro soya drinks
- Keywords
- soya, menopause, cognitive function, isoflavones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpro soya drinksDietary supplement
12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Low isoflavone | Active comparator | Alpro soya drinks containing 10 mg isoflavones per day Receives: Dietary Supplement: Alpro soya drinks |
| Medium isoflavone | Active comparator | Alpro soya drinks containing 35 mg isoflavones per day Receives: Dietary Supplement: Alpro soya drinks |
| High isoflavone | Active comparator | Alpro soya drinks containing 60 mg isoflavones per day Receives: Dietary Supplement: Alpro soya drinks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive function
Assessed using the computerised Cambridge Neuropsychological Test Automated Battery (CANTAB)
Measured: Change at Week 12 from baseline
Secondary outcomes (5)
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.
Measured: Change at Week 12 from baseline
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.
Measured: Change at Week 12 from baseline
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.
Measured: Change at Week 12 from baseline
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.
Measured: Change at Week 12 from baseline
Change in Coping
COPE Inventory
Measured: Change at Week 12 from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start14 May 2015
- Primary completion14 May 2018
- Study completion14 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Alpro Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561662
- Sponsor's protocol ID
- UREC/15/0025
- Status last verified
- May 2018
- First submitted
- 2 May 2018
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Soya Foods on Cognitive Function and Menopausal Symptoms in Postmenopausal Women.
- ClinicalTrials.gov ID
- NCT03561662
- Acronym / sponsor ID
- UREC/15/0025
- Conditions
- Menopause
- Keywords
- soya, menopause, cognitive function, isoflavones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Alpro Foundation
- Study start
- 14 May 2015 (actual)
- Primary completion
- 14 May 2018 (actual)
- Study completion
- 14 May 2018 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low isoflavone | Active comparator | Dietary Supplement: Alpro soya drinksAlpro soya drinks containing 10 mg isoflavones per day |
| Medium isoflavone | Active comparator | Dietary Supplement: Alpro soya drinksAlpro soya drinks containing 35 mg isoflavones per day |
| High isoflavone | Active comparator | Dietary Supplement: Alpro soya drinksAlpro soya drinks containing 60 mg isoflavones per day |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpro soya drinks12 weeks | Dietary supplement | High isoflavone, Low isoflavone, Medium isoflavone |
Primary outcome
Change in Cognitive function
Time frame: Change at Week 12 from baseline
Assessed using the computerised Cambridge Neuropsychological Test Automated Battery (CANTAB)
5 secondary outcomes
Change in Menopausal symptoms
Time frame: Change at Week 12 from baseline
Change in Quality of Life
Time frame: Change at Week 12 from baseline
Change in Mood
Time frame: Change at Week 12 from baseline
Change in Stress
Time frame: Change at Week 12 from baseline
Change in Coping
Time frame: Change at Week 12 from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpro soya drinks in people with Menopause, run by University of Ulster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive function (time frame: Change at Week 12 from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.