NCT04913064

Effects of White Button Mushroom on Inflammation in Obese Postmenopausal Women at High Risk of Breast Cancer

White Button Mushroom and Biomarkers of Immune Cell and Inflammatory Responses in Obese Postmenopausal Women at High Risk of Breast Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

This clinical trial studies the effects of dietary white button mushroom on inflammation (the body's process of fighting against harmful things) and immune cells (white blood cells) in postmenopausal women with both high body mass index or BMI (percentage of body fat) and high risk of breast cancer. The body is in a constant state of alert when inflammation lingers at a low level and becomes chronic, as with having button mushroom is a dietary supplement that may improving responses of immune cells (white blood cells) and decreasing chronic inflammation. Information gathered from this study may help researchers determine whether white button mushroom have any effects on body fat and breast cancer risk.

Detailed description

PRIMARY OBJECTIVE: I. To determine effects of white button mushroom (WBM) on circulating immune cell profiles, and specifically myeloid-derived suppressor cells (MDSCs), in obese (BMI \>= 30 kg/m\^2, Asian BMI \>= 25 kg/m\^2) postmenopausal women at high risk of breast cancer. SECONDARY OBJECTIVES: I. To evaluate changes in circulating biomarkers of inflammation. II. To evaluate changes in immune cell profiles and inflammation in breast adipose tissue samples. III. To evaluate tolerability of WBM in a study cohort of obese postmenopausal women. IV. To evaluate changes in BMI, central adiposity (waist circumference), and metabolic health (glucose, insulin, lipid panel, alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\]). V. To evaluate effects of WBM on diet quality and composition (food frequency questionnaires, 24 hour recall, red blood cell fatty acid profiles). OUTLINE: Participants receive white button mushroom orally (PO) daily for 3 months in the absence of disease progression or unacceptable toxicity.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
OTHER	Questionnaire Administration	Ancillary studies
DRUG	White Button Mushroom Extract	Given PO

Timeline

• Start date: 2021-07-27
• Primary completion: 2027-01-12
• Completion: 2027-01-12
• First posted: 2021-06-04
• Last updated: 2026-01-05

Locations

1 site across 1 country: United States