| Source of record | UK Trials |
| ISRCTN | ISRCTN11023622 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0547192949 |
| Public title | A pilot study to determine the effect of dietary intervention on novel biomarkers of breast cancer risk |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Cancer: Breast |
| Study hypothesis | The aim of the study is to determine the effect of dietary soy and selenium supplementation on the metabolic profile of blood and urine samples in premenopausal women at moderate-high risk of developing breast cancer. |
| Design/methodology | Randomised controlled pilot study |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | It is planned that 30 participants will complete the study. Allowing for an estimated dropout rate of 20%, approximately 38 women may initially be recruited onto the study.
Inclusion: 30 pre-menopausal women (age 35-50) at moderate to high risk of developing breast cancer. Study participants will be recruited from the breast clinic at NNUH and will be eligible for recruitment onto the study if they have one or more of the medium or high risk family histories as defined by the NICE guidelines (May 2004). |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/02/2007 |
| Anticipated end date | 01/08/2008 |
| Status of trial | Ongoing |
| Target number of participants | 30 |
| Interventions | The study will be led by Prof Aedin Cassidy, School of Medicine, Health Policy and Practice (MED) at the University of East Anglia in collaboration with Mr Simon Pain, Consultant Breast Surgeon at the Norfolk and Norwich University Hospital.
Study Outline
A flowchart of the study outline can be found in the protocol. This is a pilot study with the aim of determining the effect of dietary soy and selenium supplementation on the metabolic profile of blood and urine samples in premenopausal women at moderate-high risk of developing breast cancer. 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 pilot 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. Study participants will be recruited from the breast clinic at NNUH and will be eligible for recruitment onto the study if they have one or more of the medium or high risk family histories as defined by the NICE guidelines (May 2004).The study involves assessing urinary and plasma metabolic profiles collected at baseline and after dietary intervention of approximately one month (one menstrual cycle, ranging between 25-35 days).
Participants will be randomised into either a placebo group (15 subjects) consuming 6g non-supplemented ¿control¿ chocolate per day, or a supplementation group (15 subjects) consuming 6g chocolate (produced and donated by Nestle, Switzerland) containing a combination of soy (50mg as soy protein isolate) and selenium (200ug in the form of MSC).
Metabolomic profiling of blood and urine samples will be undertaken using 1H NMR and HPLC/MS techniques at the Institute of Food Research. Serum markers of soy (isoflavone analysis) and selenium status (plasma selenium, glutathione peroxidase) will be assessed at baseline and post-supplementation using a range of analytical techniques. In addition, recently proposed novel biomarkers of breast cancer risk, insulin-like growth factor-1 (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3) will also be measured at both time points.
Specific Information
Pre-intervention (baseline) samples: Volunteers will attend the IFR, Human Nutrition Unit to provide a fasting (8hour) 20ml baseline blood sample . This blood sample and subsequent post-intervention samples will be collected during the luteal phase (time between ovulation and the start of menstruation) of the menstrual cycle, as the metabolic profile is likely to vary through different phases of the menstrual cycle in response to hormonal changes. For two days prior to blood sampling all volunteers will be asked to keep a household measures diary of all food and drink consumed during this 48hour period. A diary and full instructions will be supplied to the volunteers for this purpose. On the second day of dietary recording (day prior to blood sampling) volunteers will be asked to complete a 24 hour urine collection.
Post-intervention sampling: Following the dietary intervention period of one menstrual cycle (25-35 days depending on cycle length), a 20ml fasting blood sample will again be taken in the HNU. In order to collect pre- and post-intervention blood and urine samples at the same phase of the menstrual cycle, each volunteer will be asked to report their usual cycle length at the start of the study. Note: volunteers will only be recruited onto the study if they have regular periods and the length of their menstrual cycle is between 25-35 days. For the two days prior to this post-intervention blood sampling the volunteers will be asked to repeat the same dietary intake as consumed prior to the baseline blood sampling. The women will be re-supplied with a copy of their pre-intervention diary as a reminder of their food consumption and will also be asked to record if they eat anything differently from the pre-intervention record. Volunteers will also be asked to undertake a 24 hour urine collection on the day before blood sampling. Analysis of blood and urine samples will be identical to the pre-intervention analyses.
Dietary Intervention: Following collection of the baseline samples, volunteers will be randomly assigned to either of two intervention groups (15 per group). This is a double blind study so both the study team and volunteers will be unaware of their group allocation:
Control group: The group will be asked to consume approximately 6g of ¿placebo¿ chocolate (approx. one square) each day for the intervention period. The chocolate will be manufactured and supplied free of charge to the study by Nestle, Switzerland. The chocolate portions will be supplied to the volunteers coded and individually wrapped.
Supplement group: This group will receive chocolate also supplied by Nestle, which will be identical in appearance to the control group, but will be supplemented with both selenium (200ug in the form of MSC) and isoflavones from soy (50mg of soy protein isolate).
As a measure of compliance all volunteers will be supplied with a record sheet to note down they time they consumed the chocolate each day. |
| Primary outcome measure(s) | The primary outcome measure is the measurement of urinary and plasma metabolic profiles. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | East Norfolk and Waveney Research Consortium (Norfolk & Norwich UH/ Norwich PCT/James Paget/NWMHP)
Norfolk & Norwich Internal Funding
|
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Prof Aedin Cassidy |
| Contact details | University of East Anglia
Norwich
United Kingdom
NR4 7TJ |
| Contact telephone | +44 01603 591539 |
| Contact fax | +44 01603 593752 |
| Contact email | a.cassidy@uea.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN11023622 |
| Date last extracted from ISRCTN register | 17/04/2008 |
