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

NCT06635005 | Recruiting DMC

• 2 other identifiers: OSU-23417NCI-2024-08360
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Insulinemic dietary pattern, high-risk, breast cancer, cardiometabolic health

Outcome Measures

Primary Outcomes (1)

• Successful translation of the low-Empirical Dietary Index for Hyperinsulinemia dietary pattern

  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 Outcomes (3)

• Plasma biomarkers of cardiometabolic health

  From baseline to 12 weeks

• Urine biomarkers of cardiometabolic health

  From baseline to 12 weeks

• Patient reported outcomes (PROs)

  Up to 12 weeks

Study Arms (1)

Prevention (Low-EDIH dietary pattern intervention)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Other: Dietary Intervention; Other: Medical Device Usage and Evaluation; Behavioral: Motivational Interviewing; Other: Nutritional Assessment; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Prevention (Low-EDIH dietary pattern intervention)

Dietary Intervention OTHER

Receive the Low-EDIH dietary pattern intervention

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Prevention (Low-EDIH dietary pattern intervention)

Medical Device Usage and Evaluation OTHER

Wear an activity tracker

Prevention (Low-EDIH dietary pattern intervention)

Motivational Interviewing BEHAVIORAL

Undergo motivational interviews

Also known as: MI, Motivational Interviewing Intervention

Prevention (Low-EDIH dietary pattern intervention)

Nutritional Assessment OTHER

Participate in nutrition counseling

Also known as: Dietary Assessment, dietary counseling, nutritional counseling

Prevention (Low-EDIH dietary pattern intervention)

Questionnaire Administration OTHER

Ancillary studies

Prevention (Low-EDIH dietary pattern intervention)

Eligibility Criteria

• Age: 45 Years+
• Gender Eligibility Details: Cis-gender is an inclusion criterion as hormone use may alter breast cancer risk
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Publications (3)

• Romanos-Nanclares A, Tabung FK, Willett WC, Rosner B, Holmes MD, Chen WY, Tamimi RM, Eliassen AH. Insulinemic potential of diet and risk of total and subtypes of breast cancer among US females. Am J Clin Nutr. 2022 Dec 19;116(6):1530-1539. doi: 10.1093/ajcn/nqac284.

  PMID: 36178066 BACKGROUND

• Lee DH, Giovannucci EL, Tabung FK. Insulin-related dietary indices predict 24-h urinary C-peptide in adult men. Br J Nutr. 2020 Jun 19:1-8. doi: 10.1017/S0007114520002184. Online ahead of print.

  PMID: 32618519 BACKGROUND

• Tabung FK, Wang W, Fung TT, Hu FB, Smith-Warner SA, Chavarro JE, Fuchs CS, Willett WC, Giovannucci EL. Development and validation of empirical indices to assess the insulinaemic potential of diet and lifestyle. Br J Nutr. 2016 Nov 28;116(10):1787-1798. doi: 10.1017/S0007114516003755. Epub 2016 Nov 8.

  PMID: 27821188 BACKGROUND

Related Links

• The Jamesline

MeSH Terms

Conditions

Patient Compliance; Breast Neoplasms

Interventions

Specimen Handling; Diet Therapy; Motivational Interviewing; Nutrition Assessment

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Nutrition Therapy; Therapeutics; Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Fred K Tabung, PhD, MSPH

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is a single arm study with a dietary pattern as intervention.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: October 3, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)