Plain English Summary
Background and study aims:
Soy (a vegetable foodstuff) contains chemicals called phyto-oestrogens (isoflavones) that have been shown to be of potential benefit to people during menopause as soy can alleviate menopausal hot flushes. It has also been shown that bones lose their density more rapidly during the immediate years following menopause. It is not really known if soy can have an effect on chemicals in the blood that reflects bone loss and growth. Therefore it is important to compare the effect of soy proteins, with and without phyto-oestrogens, on the bone health of women during this time.
This study aims to look at the effects of eating snack bars containing soy protein, with or without phyto-oestrogens, during the first two years of menopause. This will be done in such a way that neither the individual taking part, nor the investigator will know which type of bars the person has been eating.
Who can participate?
Women who have experienced menopause within the last 2 years
What does the study involve?
Participants will be asked to visit the research department a total of four times over a period of 6 months. They will also be contacted by telephone twice within this 6 month period. The first visit, that will last about 30 minutes, will involve discussing the study and signing a consent form. The subsequent visits will last around an hour.
1. At the second, third and final visit the participants will be asked to attend the clinic first thing in the morning, having fasted overnight. The blood samples will be tested for hormone levels and bone turn over makers.
2. At the second, third and final visit the participants will have an ultrasound scan examination of the lining of your womb.
3. At the second visit the participants will be given enough soy snack bars to eat twice a day (mid morning and mid afternoon) for 3 months.
What are the possible benefits and risks of participating?
Although there may be some direct benefits to some people taking part in the study, these will not be known until the study has finished. It is hoped that this study will help to provide the information needed to inform the Food Standards Agency and UK governments regarding the safety and potential benefits of eating soy and phytooestrogens to women during menopause.
Where is the study run from?
The University of Hull at Brocklehurst Building of Hull Royal Infirmary.
When is study starting and how long is it expected to run for?
The study started in July 2010 and will end in December 2012
Who is funding the study?
Food Standard Agency, UK
Who is the main contact?
Prof Stephen Atkin
stephen.atkin@hyms.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Stephen Atkin
ORCID ID
Contact details
Hull York Medical School
Michael White Centre for Diabetes
Endocrinology & Metabolism
Brocklehurst Building
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2RW
United Kingdom
+44 (0)1482 675312
stephen.atkin@hyms.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol Version 2 date: 24/02/2012
Study information
Scientific title
A double blind placebo controlled parallel trial of soy isoflavones on markers of bone turnover in females in the early menopause
Acronym
Study hypothesis
Null hypothesis:
Neither soy protein alone (15g without isoflavones) or soy protein (15g) with isoflavones (66mg) will have an effect on either bone resorption or bone formation (i.e. bone turnover) in post menopausal women at the time of their greatest bone loss.
Ethics approval
Yorkshire & The Humber - Humber Bridge Research Ethics Committee, 18/06/2010, ref: 10/H1304/5
Study design
Parallel double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Effect of soy phyto-eastrogens to people during menopause as soy have been shown to improve menopausal flusing symptoms.
Intervention
A bar containing 7.5g isolated soy protein powder (Solcon F) with 33mg of isoflavones (given twice daily) or 7.5g of the isolated soy (extracted, isoflavone free) protein alone (given twice daily) as control will be administered.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Change in bone turnover markers
Secondary outcome measures
1. Insulin resistance
2. Blood pressure
3. Lipid profile
4. Endothelial function
5. Changes in endometrial thickness
Overall trial start date
29/09/2012
Overall trial end date
12/12/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women with a follicle-stimulating hormone (FSH) and luteinizing hormone (LH) greater than 20 mU/L and amenorrhoea for 1 year with or without vasomotor instability of hot flushing will be eligible to participate
2. Caucasian women
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
200
Participant exclusion criteria
1. Patients with liver dysfunction (ALT of greater than 135 u/L) or taking drugs that may interfere with liver function
2. Patients with impaired renal function (creatinine greater than 150, glomerular filtration rate less than 30)
3. Patients who have had antibiotic treatment within the last 6 months will also be ineligible for the study as antibiotics are known to change gut microflora and thus will interfere with phytoestrogen metabolism. This will also mean that patients who start taking antibiotics during the study will have to be withdrawn
4. Patients not wishing to allow disclosure to their GPs
5. Patients on any medication within 3 months of the study including steroid inhalers or HRT
6. Patients already self-supplementing with isoflavones
7. Vegetarian or vegans
Recruitment start date
29/09/2012
Recruitment end date
12/12/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hull York Medical School
Hull
HU3 2RW
United Kingdom
Sponsor information
Organisation
Hull and East Yorkshire Hospitals NHS Trust (UK)
Sponsor details
Research and Development Department
Daisy Building
Castle Hill Hospital
Castle Road
Hull
HU16 5JQ
United Kingdom
+44 (0)1482 461903
james.illingworth@hey.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Food Standard Agency (UK), ref: T10060
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary