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

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.

Conditions

• Feasibility Pilot Study
• Compliance

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

OTHER

Dietary Intervention

Receive the Low-EDIH dietary pattern intervention

OTHER

Medical Device Usage and Evaluation

Wear an activity tracker

BEHAVIORAL

Motivational Interviewing

Undergo motivational interviews

OTHER

Nutritional Assessment

Participate in nutrition counseling

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

• American Cancer Society, Inc.

  collaborator OTHER

• Ohio State University Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Fred K Tabung, PhD, MSPH · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-10-03

Primary Completion

2026-01-06

Completion

2026-01-06

Countries

• United States

Study Locations