Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-01-09 @ 1:37 AM
Study NCT ID:
NCT06635005
Status:
RECRUITING
Last Update Posted:
2025-10-16
First Post:
2024-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Low-Insulinemic Dietary Intervention to Reduce Breast Cancer Risk in High-Risk Women
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
A Low-Insulinemic Dietary Intervention to Reduce Breast Cancer Risk in High-Risk Women
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIN-BRiCK
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2024-08360 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |