Soy, Selenium and Breast Cancer Risk

NCT00555386 | Completed

• 2 other identifiers: R1469707/Q0101/10
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

Brief Summary

There is evidence to suggest that some dietary components can reduce the risk of breast cancer. In this pilot study two such components, isoflavones (compounds found in soy products) and selenium, will be given to women classed as at moderate to high risk of the disease. The aim is to determine some novel biomarkers of risk and to see the effect of supplementation on them.

Conditions

Breast Cancer Risk

Keywords

Selenium; Soy; Breast Cancer Risk

Outcome Measures

Primary Outcomes (1)

• To determine the effect of supplementation with selenium and isoflavones on biomarkers of breast cancer risk.

  25-35 days

Secondary Outcomes (1)

• Identify novel biomarkers of breast cancer risk through metabolomic analysis of samples collect.

  25-35 days

Study Arms (2)

1

ACTIVE COMPARATOR

6g of chocolate (supplemented with selenium and isoflavones) per day for the duration of one menstrual cycle (25-35 days)

Dietary Supplement: Soy and Selenium

2

PLACEBO COMPARATOR

6g of chocolate (control) per day for the duration of one menstrual cycle (25-35 days)

Dietary Supplement: Soy and Selenium

Interventions

Soy and Selenium DIETARY_SUPPLEMENT

6g of chocolate per day Control group with no supplementation Active group 50mg of soy protein isolate + 200µg selenium in the form of MSC

1; 2

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pre menopausal women (age 35-50)at moderate to high risk of breast cancer based on family history (NICE guidelines)
• 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

You may not qualify if:

• Current or previous diagnosis of breast cancer or cancer of any other site
• 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

Sponsors & Collaborators

• University of East Anglia: lead
• Quadram Institute Bioscience: collaborator
• Big C Local Cancer Research and Care: collaborator
• Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK): collaborator

Study Sites (3)

Institute of Food Research

Norwich, Norfolk, NR4 7UA, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

University of East Anglia

Norwich, Norfolk, NR47TJ, United Kingdom

Location

Related Publications (33)

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MeSH Terms

Interventions

Selenium

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Minerals

Study Officials

• Aedin Cassidy, PhD

  University of East Anglia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 7, 2007
• First Posted: November 8, 2007
• Study Start: April 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: August 1, 2008
• Last Updated: September 25, 2008

Record last verified: 2008-09

Locations

GB (3)