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A Pilot Study of the Flaxseed Effects on Hormones and Lignans: Role of Race, Genes, and Gut Microbiome


N/A
45 Years
75 Years
Open (Enrolling)
Female
Healthy, no Evidence of Disease

Thank you

Trial Information

A Pilot Study of the Flaxseed Effects on Hormones and Lignans: Role of Race, Genes, and Gut Microbiome


PRIMARY OBJECTIVES:

I. To determine associations between the composition of the gut bacterial communities and
baseline levels of the mammalian lignans and steroid hormones.

II. To determine how variation in gut microbial community composition and in steroid hormone
and xenobiotic metabolizing genes affects the metabolism of mammalian lignans and steroid
hormones after exposure to a lignan-rich food (flaxseed).

III. To determine how these associations differ by race (i.e., African American and European
American women).

OUTLINE: Participants are randomized to 1 of 2 treatment groups.

GROUP I: Participants receive flaxseed orally (PO) daily for 6 weeks. After a usual diet
"washout" period of 8 weeks, patients crossover to Group II.

GROUP II: Participants maintain a usual diet for 6 weeks. After a usual diet "washout"
period of 8 weeks, patients crossover to Group I.

After completion of study treatment, participants are followed up for 30 days.


Inclusion Criteria:



- Participant must understand the investigational nature of this study and sign an
Independent Ethics Committee/Institutional Review Board approved written informed
consent form prior to receiving any study related procedure

- Participant must be a non-Hispanic white or non-Hispanic black (self-reported race)
woman and postmenopausal; postmenopausal will be defined as no menstrual cycle in the
past 12 months; women with a hysterectomy but with intact ovaries will be included if
aged >= 55 years

- Willingness to comply with the requirements of the study

- Able to provide own transportation to and from Roswell Park Cancer Institute (RPCI)

Exclusion Criteria:

- Unwilling or unable to follow protocol requirements

- Self-reported race other than non-Hispanic white or non-Hispanic black

- Use, in the 2 months prior to week 1 visit, of antibiotics, hormone replacement
therapy, nonprescription hormones or herbal supplements for menopausal symptoms, or
flaxseed supplements

- Nut or seed allergy

- Self-reported inflammatory bowel disease

- Gastric bypass

- Use of thyroid replacement medication (Synthroid or similar) for < 1 year

- Any condition which in the investigator's opinion deems the participant an unsuitable
candidate to receive flaxseed

- Chemotherapy/radiation within the past year

- Body weight greater than 400 pounds (limit of Tanita scale)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Relative percent of Eubacteria composition from qPCR associated with lignan levels

Outcome Time Frame:

Up to week 21

Safety Issue:

No

Principal Investigator

Susan McCann

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

I 216812

NCT ID:

NCT01698294

Start Date:

December 2012

Completion Date:

Related Keywords:

  • Healthy, no Evidence of Disease
  • gut microbiome; hormones; women; race; phytoestrogens

Name

Location
Roswell Park Cancer Institute Buffalo, New York  14263