30 Participants Needed

Dietary Intervention for Breast Cancer Risk Reduction

(LIN-BRiCK Trial)

TO
Overseen ByThe Ohio State University Comprehensive Cancer Center
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that changes in anti-hyperglycemic or lipid-lowering medications should be avoided unless necessary. You can continue using endocrine therapy, but you cannot change the dose or schedule during the study.

What data supports the effectiveness of the low-insulinemic dietary intervention treatment for breast cancer risk reduction?

The research indicates that diets with high glycemic index (GI) and glycemic load (GL) are not associated with an increased risk of breast cancer in postmenopausal women, suggesting that a low-insulinemic diet, which focuses on low GI and GL foods, may not increase breast cancer risk. However, the studies do not provide direct evidence that such a diet reduces breast cancer risk.12345

Is a low-glycemic diet safe for humans?

Research indicates that low-glycemic diets are generally safe for humans, as they have been associated with favorable effects like weight loss, improved insulin sensitivity, and reduced blood pressure without any reported adverse effects.16789

How does the Low-Insulinemic Dietary Intervention treatment for breast cancer risk reduction differ from other treatments?

The Low-Insulinemic Dietary Intervention is unique because it focuses on reducing insulin levels by consuming foods with a low glycemic index (which measure how quickly foods raise blood sugar levels), potentially influencing insulin-like growth factor levels linked to breast cancer risk. Unlike traditional treatments that may involve medication or surgery, this approach uses dietary changes to address risk factors associated with breast cancer.1241011

What is the purpose of this trial?

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.

Research Team

FK

Fred K Tabung, PhD, MSPH

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for high-risk women who may benefit from a new diet aimed at reducing breast cancer risk. The diet focuses on lowering blood insulin levels and includes plant proteins, fruits, vegetables, whole grains, and dietary fiber while being low in animal proteins and fats.

Inclusion Criteria

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%
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
I am a cis-gender woman, 45 or older, or post-menopausal.
See 2 more

Exclusion Criteria

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
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
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants receive the low-EDIH dietary pattern intervention consisting of 6 group nutrition education sessions and 3 individual counseling sessions.

11 weeks
6 group sessions (in-person), 3 individual sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after the dietary intervention

1 week
1 visit (in-person or virtual)

Treatment Details

Interventions

  • Low-Insulinemic Dietary Intervention
Trial Overview The study evaluates the feasibility of adhering to a low-insulinemic diet that differs from typical American diets. It involves using medical devices for monitoring, motivational interviews to support adherence, biospecimen collection for analysis, nutritional assessments, and questionnaires.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Prevention (Low-EDIH dietary pattern intervention)Experimental Treatment6 Interventions
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

American Cancer Society, Inc.

Collaborator

Trials
237
Recruited
110,000+

Findings from Research

In a study involving 4010 postmenopausal women at high cardiovascular disease risk, no significant associations were found between dietary glycemic index (GI) or glycemic load (GL) and the incidence of invasive breast cancer.
The analysis, which included multivariable-adjusted hazard ratios and repeated measures of dietary intake, indicated that neither high GI nor GL diets increased the risk of breast cancer in this population.
Glycemic index, glycemic load and invasive breast cancer incidence in postmenopausal women: The PREDIMED study.Castro-Quezada, I., Sánchez-Villegas, A., Martínez-González, MÁ., et al.[2018]
In a study involving women from the Italian section of the EPIC, a high glycemic load (GL) diet was linked to a 45% increased risk of developing breast cancer over 11 years, suggesting a potential dietary risk factor.
Conversely, dietary glycemic index (GI) and total carbohydrate intake did not show a significant association with breast cancer risk, indicating that GL may be a more critical factor in this context.
High glycemic diet and breast cancer occurrence in the Italian EPIC cohort.Sieri, S., Pala, V., Brighenti, F., et al.[2016]
A systematic review of 53 cohort studies involving over 100,000 cancer cases found a weak association between dietary glycemic index (GI) and glycemic load (GL) with the risk of diabetes-related cancers, indicating that high GI/GL diets may not significantly increase cancer risk.
Most studies showed no significant link between insulin index (II) or insulin load (IL) and cancer risk, with only one study reporting a positive association for IL in endometrial cancer, suggesting that more research is needed to clarify these relationships.
Dietary glycemic index, glycemic load, insulin index, insulin load and risk of diabetes-related cancers: A systematic review of cohort studies.Hatami Marbini, M., Amiri, F., Sajadi Hezaveh, Z.[2021]

References

Glycemic index, glycemic load and invasive breast cancer incidence in postmenopausal women: The PREDIMED study. [2018]
High glycemic diet and breast cancer occurrence in the Italian EPIC cohort. [2016]
Dietary glycemic index, glycemic load, insulin index, insulin load and risk of diabetes-related cancers: A systematic review of cohort studies. [2021]
Dietary glycemic index, glycemic load, and risk of incident breast cancer in postmenopausal women. [2019]
Postdiagnostic Dietary Glycemic Index, Glycemic Load, Dietary Insulin Index, and Insulin Load and Breast Cancer Survival. [2022]
Effect of low or high glycemic load diets on experimentally induced mammary carcinogenesis in rats. [2018]
More favorable dietary patterns are associated with lower glycemic load in older adults. [2016]
Reduced glycemic index and glycemic load diets do not increase the effects of energy restriction on weight loss and insulin sensitivity in obese men and women. [2023]
Metabolic effects of low glycaemic index diets. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Relation between Breast Cancer and High Glycemic Index or Glycemic Load: A Meta-analysis of Prospective Cohort Studies. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Dietary glycemic load and breast cancer risk in the Women's Health Study. [2019]
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