Biomarkers in Post-Menopausal Women Receiving Flaxseed

No Evidence of Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698294
• Other study ID #: I 216812
• Secondary ID: NCI-2012-01246I
• Status: Completed
• Phase: N/A
• Start date: December 14, 2012
• Est. completion date: June 8, 2017

Study information

• Verified date: May 2022
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized clinical trial studies biomarkers in post-menopausal women receiving flaxseed. Studying samples of blood, urine, and feces in the laboratory from participants receiving flaxseed may help doctors understand the effects of flaxseed on biomarkers.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: June 8, 2017
• Est. primary completion date: June 8, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 80 Years

Eligibility

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 45 to 80 years of age 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

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)

Related Conditions & MeSH terms

• No Evidence of Disease

Intervention

Other:
• Clinical Observation
Participants maintain usual diet and undergo clinical observation

Dietary Supplement:
• Flaxseed
Given PO

Other:
• Laboratory Biomarker Analysis
Correlative studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (5)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	Fred Hutchinson Cancer Center, National Cancer Institute (NCI), State University of New York at Buffalo, University of Toronto

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative percent of Eubacteria composition from quantitative polymerase chain reaction (qPCR) associated with lignan levels		Up to week 21
Primary	Steroid hormone and lignans levels after exposure to a lignan-rich food (flaxseed)		Up to week 21