Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2007-04-30
2008-08-31
Brief Summary
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Detailed Description
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In this pilot project, we will employ a combination of disciplines to examine the effect of dietary intervention in a group of women defined by NICE guidelines as being at increased risk (moderate-high) of developing breast cancer, using metabolomics to assess the tractability of biomarkers in response to the dietary intervention. Such trials are urgently needed to examine the protective effects of diet in women classified at increased risk and who are still in the 'zone of reversibility'. The results of this study will be used to justify and optimise larger scale intervention trials and ultimately to develop appropriate dietary recommendations for the prevention of breast cancer.
A dietary intervention study based on a randomised double-blind parallel design will be conducted in 30 pre-menopausal women (age 35-50) at moderate to high risk of developing breast cancer. The metabolomic profiles of urine and serum samples (collected at baseline and after dietary intervention) will be assessed. Participants will be randomised into two groups; the placebo group (consuming 6g of non-supplemented chocolate per day) and the supplemented group (consuming 6g of chocolate containing both soy and selenium per day). The intervention will last for the duration of one menstrual cycle.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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1
6g of chocolate (supplemented with selenium and isoflavones) per day for the duration of one menstrual cycle (25-35 days)
Soy and Selenium
6g of chocolate per day Control group with no supplementation Active group 50mg of soy protein isolate + 200µg selenium in the form of MSC
2
6g of chocolate (control) per day for the duration of one menstrual cycle (25-35 days)
Soy and Selenium
6g of chocolate per day Control group with no supplementation Active group 50mg of soy protein isolate + 200µg selenium in the form of MSC
Interventions
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Soy and Selenium
6g of chocolate per day Control group with no supplementation Active group 50mg of soy protein isolate + 200µg selenium in the form of MSC
Eligibility Criteria
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Inclusion Criteria
* Attending Breast Clinic at NNUH
* Willing to consume 6g of chocolate per day for 25-35 days
* Regular menstrual cycle of 25-35 days in length
Exclusion Criteria
* Diagnosis of hypertension (requiring active treatment)/diabetes/ coronary heart disease/ gastrointestinal disease/ any other systemic disease requiring treatment
* Regularly taking any prescribed medication within the last six months (including oral contraceptives)
* Fitted with a hormone releasing device
* Pregnant or lactating in the previous 12 months
* Using laxatives or antacids more than once a week
* Routinely taking soy or selenium supplements in the last twelve months
* Regularly taking any dietary or herbal supplements in the last six months
* Participation in any intervention study (soy or selenium) in the previous twelve months
* Parallel participation in another research study involving either dietary or medical intervention or sampling of biological fluids/materials
* Blood donation within sixteen weeks of study start/finish
* BMI \<18.5 or \>35
* Allergy to any chocolate/dairy/soy-based food products
35 Years
50 Years
FEMALE
Yes
Sponsors
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Quadram Institute Bioscience
OTHER
Big C Local Cancer Research and Care
UNKNOWN
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
OTHER
University of East Anglia
OTHER
Responsible Party
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University of East Anglia
Principal Investigators
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Aedin Cassidy, PhD
Role: PRINCIPAL_INVESTIGATOR
University of East Anglia
Locations
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Institute of Food Research
Norwich, Norfolk, United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom
University of East Anglia
Norwich, Norfolk, United Kingdom
Countries
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References
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Cassidy A, Bingham S, Setchell KD. Biological effects of a diet of soy protein rich in isoflavones on the menstrual cycle of premenopausal women. Am J Clin Nutr. 1994 Sep;60(3):333-40. doi: 10.1093/ajcn/60.3.333.
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Other Identifiers
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07/Q0101/10
Identifier Type: -
Identifier Source: secondary_id
R14697
Identifier Type: -
Identifier Source: org_study_id