Trial Title:
A Low-Insulinemic Dietary Intervention to Reduce Breast Cancer Risk in High-Risk Women
NCT ID:
NCT06635005
Condition:
Feasibility Pilot Study
Compliance
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Insulinemic dietary pattern, high-risk, breast cancer, cardiometabolic health
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Masking description:
This is a single arm study with a dietary pattern as intervention.
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Prevention (Low-EDIH dietary pattern intervention)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Dietary Intervention
Description:
Receive the Low-EDIH dietary pattern intervention
Arm group label:
Prevention (Low-EDIH dietary pattern intervention)
Other name:
Dietary Modification
Other name:
intervention, dietary
Other name:
Nutrition Intervention
Other name:
Nutrition Interventions
Other name:
Nutritional Interventions
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Wear an activity tracker
Arm group label:
Prevention (Low-EDIH dietary pattern intervention)
Intervention type:
Behavioral
Intervention name:
Motivational Interviewing
Description:
Undergo motivational interviews
Arm group label:
Prevention (Low-EDIH dietary pattern intervention)
Other name:
MI
Other name:
Motivational Interviewing Intervention
Intervention type:
Other
Intervention name:
Nutritional Assessment
Description:
Participate in nutrition counseling
Arm group label:
Prevention (Low-EDIH dietary pattern intervention)
Other name:
Dietary Assessment
Other name:
dietary counseling
Other name:
nutritional counseling
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Prevention (Low-EDIH dietary pattern intervention)
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Gender based:
Yes
Gender description:
Cis-gender is an inclusion criterion as hormone use may alter breast cancer risk
Minimum age:
45 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Fred K. Tabung, PhD, MSPH
Phone:
614-293-7398
Email:
fred.tabung@osumc.edu
Investigator:
Last name:
Fred K. Tabung, PhD, MSPH
Email:
Principal Investigator
Start date:
October 3, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Ohio State University Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
American Cancer Society, Inc.
Agency class:
Other
Source:
Ohio State University Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06635005
http://cancer.osu.edu
