Feasibility Pilot StudyLIN-BRiCKNCT06635005
A Low-Insulinemic Dietary Intervention to Reduce Breast Cancer Risk in High-Risk Women
A study testing Biospecimen Collection, Dietary Intervention and Medical Device Usage and Evaluation in people with Feasibility Pilot Study and Compliance, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Feasibility Pilot Study, Compliance
- What is being tested?
- Biospecimen Collection, Dietary Intervention and Medical Device Usage and Evaluation
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2024to 6 Jan 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
- Conditions
- Feasibility Pilot Study, Compliance
- Being tested
- Biospecimen Collection, Dietary Intervention, Medical Device Usage and Evaluation, Motivational Interviewing, Nutritional Assessment
- Keywords
- Insulinemic dietary pattern, high-risk, breast cancer, cardiometabolic health
- Medical subject headings
- Patient Compliance, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Dietary InterventionOther
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Receive the Low-EDIH dietary pattern intervention
Medical Device Usage and EvaluationOther
Wear an activity tracker
Motivational InterviewingBehavioural
Also called MI, Motivational Interviewing Intervention
Undergo motivational interviews
Nutritional AssessmentOther
Also called Dietary Assessment, dietary counseling, nutritional counseling
Participate in nutrition counseling
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Other: Dietary Intervention; Other: Medical Device Usage and Evaluation; Behavioral: Motivational Interviewing; Other: Nutritional Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 weeks
Secondary outcomes (3)
Plasma biomarkers of cardiometabolic health
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.
Measured: From baseline to 12 weeks
Urine biomarkers of cardiometabolic health
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.
Measured: From baseline to 12 weeks
Patient reported outcomes (PROs)
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.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start3 Oct 2024
- Primary completion6 Jan 2026
- Study completion6 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Feasibility Pilot StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Fred Tabung, Ohio State University Comprehensive Cancer Center
- Investigators
- Fred K Tabung, PhD, MSPH, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635005
- Sponsor's protocol ID
- OSU-23417
- Other IDs
- NCI-2024-08360
- Acronym
- LIN-BRiCK
- Status last verified
- May 2026
- First submitted
- 8 Oct 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36178066Lee 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.
PubMed 32618519Tabung 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.
PubMed 27821188