Studying the Effect of Freeze-Dried Table Grape Powder on Blood Estrogen Levels in Postmenopausal Women

NCT00611104 | Completed DMC

• 3 other identifiers: MC0536CDR000058121906-002061
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Studying samples of blood and urine in the laboratory from participants receiving freeze-dried table grape powder may help doctors understand the effect of this drug on blood estrogen levels. PURPOSE: This clinical trial is studying the effect of freeze-dried table grape powder on blood estrogen levels in postmenopausal women.

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (2)

• Serum levels of plasma estrone (E1), estradiol, E1-conjugates, and E1-sulfates

• Bioavailability of the freeze-dried table grape powder in humans

Interventions

standardized freeze-dried table grape powder DIETARY_SUPPLEMENT

laboratory biomarker analysis OTHER

pharmacological study OTHER

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Female * Postmenopausal (defined as women who have had both ovaries removed or no menstrual period for at least 12 consecutive months) * Able to give informed consent and complete food records alone or with assistance

DISEASE CHARACTERISTICS: * Participant in the Mayo Mammography Health Study * Has consented to provide baseline mammogram for digitization PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Female * Postmenopausal (defined as women who have had both ovaries removed or no menstrual period for at least 12 consecutive months) * Able to give informed consent and complete food records alone or with assistance * Willing to provide research blood and urine samples * Must be a non-smoker * Willing to maintain current weight * No history of breast ductal carcinoma in situ or any other cancer, except basal cell or squamous cell skin cancer or lobular carcinoma in situ * No history of allergic or other adverse reaction to grapes * No history of diabetes or glucose intolerance PRIOR CONCURRENT THERAPY: * No concurrent hormone therapy, including estradiol, estrone, or progestins

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Janet E. Olson, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: February 8, 2008
• Study Start: August 4, 2008
• Primary Completion: August 22, 2014
• Study Completion: August 22, 2014
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)