What’s the study about?
The purpose of this study is to determine whether adding flaxseed (a food high in compounds that can change hormones) to a regular diet changes hormones that are related to breast cancer risk and if the effect of flaxseed differs between African-American and Caucasian women.
If you sign up for A Pilot Study of the Flaxseed Effects on Hormones and Lignans: Role of Race, Genes, and Gut Microbiome, the research team will contact you to confirm that you are eligible. If you choose to participate in the study, you will be asked to:
• Be randomly assigned (like the flip of a coin) to eat 2 tablespoons of ground flaxseed per day for 6 weeks or to maintain your usual diet. Two months later, you will switch into the other group for 6 weeks.
• Complete an interview about your diet, health habits, medical history, reproductive history, and other information related to a woman’s risk of developing breast cancer.
• Attend 5 morning visits throughout the duration of the study at the Prevention Center at Roswell Park Cancer Institute. At these visits, you will be asked to provide a blood sample and have your height, weight, and body fat measured. You will also be asked to bring a urine sample from the night before and a small sample of that day’s bowel movement that you collected at your home. The research team will provide the containers for these samples, and instructions on how to collect them. The research team will also call you periodically to ask you everything you ate and drank in the past 24 hours.
Who is conducting the study?
Susan McCann, PhD, Roswell Park Cancer Institute, in collaboration with Johanna Lampe, PhD, Fred Hutchinson Cancer Research Center
Roswell Park Cancer Institute, Buffalo, New York
Who can participate?
You can sign up for A Pilot Study of the Flaxseed Effects on Hormones and Lignans: Role of Race, Genes, and Gut Microbiome
if you meet ALL of these MAIN criteria:
• You are a woman between 45 and 75 years of age.
• You have stopped having your menstrual periods (you are postmenopausal).
• Your last menstrual period was more than 12 months ago.
• You have never been diagnosed with any cancer (basal and squamous cell skin cancers are OK).
• You have never had gastric bypass surgery.
• You have NOT taken estrogen or other female hormones (hormone replacement therapy, nonprescription hormones, or herbal supplements for menopausal symptoms) within the past 2 months.
• You do NOT eat flaxseed or take a flaxseed supplement regularly.
• You are NOT allergic to seeds or nuts.
• You have NOT taken antibiotics in the last 3 months.
• You live near or are willing to travel (at your own expense) to Roswell Park Cancer Institute in Buffalo, New York.
• You self-identify as:
o Non-Hispanic White OR
o Non-Hispanic Black
After you RSVP, the research team will contact you to ask additional questions to be sure that the study is a good fit for you.