RecruitingNot ApplicableNCT06635005

A Low-Insulinemic Dietary Intervention to Reduce Breast Cancer Risk in High-Risk Women


Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

30 participants

Start Date

Oct 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial tests whether a new dietary pattern that consists of foods that lower the blood insulin response can reduce breast cancer risk in high-risk women. In a large group of patients, this new dietary pattern was associated with reduced risk of multiple cancers and reduced risk of long-term weight gain. Parts of this new dietary pattern are quite different from typical dietary recommendations, and much education is needed. Overall, compared to the typical American diet, this new dietary pattern is moderately low in total fat and saturated fat, low in protein from animal foods but high in protein from plant sources, high in fruits and vegetables, high in whole grains, and high in dietary fiber. We will determine if a low-insulinemic dietary pattern intervention is feasible and effective in reducing breast cancer risk in high-risk women.


Eligibility

Sex: FEMALEMin Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a special low-insulin diet to help reduce breast cancer risk in postmenopausal women who are overweight and considered high-risk for developing breast cancer. High insulin levels are linked to cancer growth, and this dietary approach aims to lower insulin and potentially reduce the risk of breast cancer developing. **You may be eligible if...** - You are a woman, 45 or older, or postmenopausal - Your BMI is between 25 and 35 kg/m² - You are at high risk for breast cancer (as determined by standard risk assessment tools) - You are receiving care at the Ohio State University's Spielman Comprehensive Breast Center - You can read and understand English **You may NOT be eligible if...** - You were diagnosed with breast cancer in the past 5 years - You have metastatic breast cancer - You are premenopausal or under 45 - You have type 1 diabetes or are insulin-dependent - You have serious uncontrolled illnesses (lung, heart, or metabolic disease) - You have food allergies to wheat, nuts, seeds, fish, or dairy - You are currently on a special diet (vegan, keto, etc.) or planning to start one - You are pregnant, trying to conceive, or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

OTHERDietary Intervention

Receive the Low-EDIH dietary pattern intervention

OTHERMedical Device Usage and Evaluation

Wear an activity tracker

BEHAVIORALMotivational Interviewing

Undergo motivational interviews

OTHERNutritional Assessment

Participate in nutrition counseling

OTHERQuestionnaire Administration

Ancillary studies


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06635005


Related Trials