A Low-Insulinemic Dietary Intervention to Reduce Breast Cancer Risk in High-Risk Women (LIN-BRiCK)

May 6, 2026 updated by: Fred Tabung, Ohio State University Comprehensive Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. Evaluate the feasibility of translating the low-Empirical Dietary Index for Hyperinsulinemia (EDIH) dietary pattern intervention from epidemiologic cohorts to the clinic in a single arm phase I trial among postmenopausal women at high risk for cancer and evaluate safety.

SECONDARY OBJECTIVES:

I. Determine the change in patient reported outcomes (PRO) under the Low-EDIH dietary pattern at 12 weeks from baseline.

II. Evaluate the change in cardiometabolic biomarker profiles at 12 weeks from baseline (a) glycemic control and insulin response parameters measured using fasting glucose, insulin, hemoglobin A1C, C-peptide, HOMA-IR, HOMA-B and IGFBP-1, IGFBP-2, (b) lipid profiles (total cholesterol, triglycerides [TG], low density lipoprotein [LDL], higher high density lipoprotein [HDL]).

III. Assess change in circulating biomarkers associated with risk of breast cancer and low-grade chronic inflammatory state including C-reactive protein (CRP), TNFalpha-R2, IL-6 and leptin/adiponectin ratio at 12 weeks from baseline.

EXPLORATORY OBJECTIVES:

I. Collect stool samples and process for subsequent assessment of changes in the fecal microbiome structure and function related to the low-EDIH dietary pattern intervention.

II. Collect 24-hour urine samples and process for subsequent assessment of changes in targeted and non-targeted metabolomics and lipidomics alterations related to the low-EDIH dietary pattern intervention.

OUTLINE:

Participants receive the low-EDIH dietary pattern intervention consisting of 6 group nutrition education sessions focusing on foods to prioritize within each food group, food combinations, food preparation, discussion, simple cooking demonstrations, food tastings, smart shopping advising, and a question/answer period over 2 hours each at weeks 0, 1, 2, 3, 5, and 6. Participants also attend 3 in-person or virtual individual nutrition counseling and motivational interviewing sessions over 30 minutes each at weeks 3 and 5, between weeks 7 and 9, and between weeks 9 and 11. Participants also wear an activity tracker and undergo blood sample collection on the study.

After completion of study intervention, participants are followed up in week 12.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age ≥ 45 years OR post-menopausal AND cis-gender women at study registration.
  • Overweight or World Health Organization (WHO) class 1 obese as defined by a body mass index (BMI) of 25 to 35 kg/m^2.
  • High risk for breast cancer at the discretion of the physician, using standard definitions such as a Gail 5-year risk of ≥ 2% or Tyrer Cuzick version (v) 8.0 10-year risk of ≥ 5%.
  • Concurrent or prior use of endocrine therapy is allowed. Any dose or schedule change is not permitted for the duration of the study.
  • Currently established care or previously seen at the Ohio State University Comprehensive Cancer Center (OSUCCC) Stefanie Spielman Comprehensive Breast Center (SSCBC) high risk breast clinic.

Exclusion Criteria:

  • Prior diagnosis of breast cancer within past 5 years.
  • Metastatic breast cancer (at study start or during study period).
  • BMI > 35 kg/m^2 or < 25 kg/m^2.
  • Pre-menopausal women or < 45 years of age.
  • Assigned male at birth.
  • Uncontrolled intercurrent illness including lung disease, heart disease, metabolic disease; exacerbations for disease in past 8 weeks; unstable on medications for chronic conditions in past 6 weeks. This could affect compliance and engagement with study intervention. Change in anti-hyperglycemic or lipid lowering medications is best avoided for the duration of the study unless deemed necessary by treating provider or required for acute exacerbation of existing illness.
  • Type 1 diabetes mellitus (DM) or insulin dependent, or evidence of brittle diabetes.
  • Presence of food allergies or intolerances to wheat, nuts, seeds, fish, or dairy foods.
  • Currently on special diet for known metabolic or gastrointestinal disease, or planning to start a specific dietary regimen such as vegetarian, vegan, ketogenic, low-fat diets, etc.
  • Uncontrolled psychiatric illness/social situations that would limit compliance with study requirements.
  • Unwilling or unable to follow protocol requirements.
  • Pregnant, trying to get pregnant, or nursing.
  • Any condition which in the investigator's opinion deems the subject an unsuitable candidate to participate in this study.
  • Non-English speaking, as the teaching materials and educational sessions have not yet been translated into additional languages.
  • Prisoners or other institutionalized patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prevention (Low-EDIH dietary pattern intervention)
Participants receive the low-EDIH dietary pattern intervention consisting of 6 group nutrition education sessions focusing on foods to prioritize within each food group, food combinations, food preparation, discussion, simple cooking demonstrations, food tastings, smart shopping advising, and a question/answer period over 2 hours each at weeks 0, 1, 2, 3, 5, and 6. Participants also attend 3 in-person or virtual individual nutrition counseling and motivational interviewing sessions over 30 minutes each at weeks 3 and 5, between weeks 7 and 9, and between weeks 9 and 11. Participants also wear an activity tracker and undergo blood sample collection on study.
Other: Questionnaire Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Other: Medical Device Usage and Evaluation
Wear an activity tracker
Other: Dietary Intervention
Receive the Low-EDIH dietary pattern intervention
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions
Behavioral: Motivational Interviewing
Undergo motivational interviews
Other Names:
  • MI
  • Motivational Interviewing Intervention
Other: Nutritional Assessment
Participate in nutrition counseling
Other Names:
  • dietary counseling
  • Dietary Assessment
  • nutritional counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful translation of the low-Empirical Dietary Index for Hyperinsulinemia dietary pattern
Time Frame: Up to 12 weeks
High compliance will be defined as > 80% of participants achieving and maintaining scores ≥ median 0.06. Will be measured by the low-Empirical Dietary Index for Hyperinsulinemia scores. Descriptive statistics (i.e., means, standard deviations for continuous variables, and frequencies and percentages for discrete data) will be used to summarize demographics and clinical characteristics of study participants. Will be tested using multivariable-adjusted general linear mixed regression to accommodate within-person variance across post-baseline timepoints via a per-subject random effect. Will evaluate model assumptions via regression diagnostics and adjust model structure and outcome transformations as necessary to ensure proper model fit. Will be adjusted for age, baseline total caloric intake, body weight, and baseline value.
Up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma biomarkers of cardiometabolic health
Time Frame: From baseline to 12 weeks
Plasma biomarkers of cardiometabolic health include C-peptide, and IGFBP-1, IGFBP-2. Descriptive statistics (i.e., means, standard deviations for continuous variables, and frequencies and percentages for discrete data) will be used to summarize demographics and clinical characteristics of study participants. Will be tested using multivariable-adjusted general linear mixed regression to accommodate within-person variance across post-baseline timepoints via a per-subject random effect. Will evaluate model assumptions via regression diagnostics and adjust model structure and outcome transformations as necessary to ensure proper model fit. Will be adjusted for age, baseline total caloric intake, body weight, and baseline value.
From baseline to 12 weeks
Urine biomarkers of cardiometabolic health
Time Frame: From baseline to 12 weeks
Descriptive statistics (i.e., means, standard deviations for continuous variables, and frequencies and percentages for discrete data) will be used to summarize demographics and clinical characteristics of study participants. Will be tested using multivariable-adjusted general linear mixed regression to accommodate within-person variance across post-baseline timepoints via a per-subject random effect. Will evaluate model assumptions via regression diagnostics and adjust model structure and outcome transformations as necessary to ensure proper model fit. Will be adjusted for age, baseline total caloric intake, body weight, and baseline value.
From baseline to 12 weeks
Patient reported outcomes (PROs)
Time Frame: Up to 12 weeks
PROs will be assessed using Patient-Reported Outcomes Measurement Information System scales 29 Profile version 2.1 (domains: physical function, social roles, fatigue, depression, anxiety, pain, and sleep disturbance) and the Global Health Short Form. Descriptive statistics (i.e., means, standard deviations for continuous variables, and frequencies and percentages for discrete data) will be used to summarize demographics and clinical characteristics of study participants. Will be tested using multivariable-adjusted general linear mixed regression to accommodate within-person variance across post-baseline timepoints via a per-subject random effect. Will evaluate model assumptions via regression diagnostics and adjust model structure and outcome transformations as necessary to ensure proper model fit. Will be adjusted for age, baseline total caloric intake, body weight, and baseline value.
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Fred K Tabung, PhD, MSPH, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2024

Primary Completion (Actual)

January 6, 2026

Study Completion (Actual)

January 6, 2026

Study Registration Dates

First Submitted

October 8, 2024

First Submitted That Met QC Criteria

October 8, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-23417
  • NCI-2024-08360 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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