Clinical trial · Interventional
A Low-Insulinemic Dietary Intervention to Reduce Breast Cancer Risk in High-Risk Women
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Compliance | — | UNRESOLVED | — |
| Feasibility Pilot Study | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Dietary Intervention | Other | — | UNRESOLVED |
| Medical Device Usage and Evaluation | Other | — | UNRESOLVED |
| Motivational Interviewing | Behavioral | — | UNRESOLVED |
| Nutritional Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prevention (Low-EDIH dietary pattern intervention)
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Dietary Intervention
- Other: Medical Device Usage and Evaluation
- Behavioral: Motivational Interviewing
- Other: Nutritional Assessment
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Successful translation of the low-Empirical Dietary Index for Hyperinsulinemia dietary pattern
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDRomanos-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
- BACKGROUNDLee DH, Giovannucci EL, Tabung FK. Insulin-related dietary indices predict 24-h urinary C-peptide in adult men. Br J Nutr. 2026 Mar 14;135(5):577-584. doi: 10.1017/S0007114520002184. Epub 2020 Oct 19. PMID 32618519
- BACKGROUNDTabung 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