Dietary Intervention for Breast Cancer Risk Reduction

(LIN-BRiCK Trial)

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Breast cancer, BMI, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Low-Insulinemic Dietary Intervention can lower breast cancer risk in high-risk women. The diet emphasizes foods that cause a low insulin response, including fruits, vegetables, whole grains, and plant-based proteins. Post-menopausal women with a BMI between 25 and 35 who are receiving care at a specific cancer center may be suitable candidates. Participants will attend nutrition education sessions, receive counseling, and track their activity to assess the diet's effectiveness. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new dietary recommendations for breast cancer prevention.

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 prior data suggests that this dietary intervention is safe for reducing breast cancer risk?

Research has shown that diets lowering the body's insulin response can be safe and beneficial. Studies have found that consuming foods with a low glycemic index (GI) can reduce the risk of several types of cancer. These foods digest slowly, helping to maintain stable blood sugar and insulin levels. One study found that reducing the insulin-related effects of a diet may lower the risk of breast cancer.

Importantly, no evidence suggests that this type of diet increases breast cancer risk. Instead, it may improve health by regulating blood sugar and reducing the risk of heart disease. So far, this dietary approach appears safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Low-Insulinemic Dietary Intervention for reducing breast cancer risk because it offers a non-pharmacological approach to prevention. Unlike typical treatments that focus on medication, this intervention emphasizes dietary changes that potentially lower insulin levels, which may be linked to cancer risk reduction. This approach is unique because it combines nutrition education, motivational interviewing, and practical cooking demonstrations, empowering participants to make sustainable lifestyle changes. By focusing on diet and lifestyle, this method could provide a side-effect-free option for those looking to proactively manage their breast cancer risk.

What evidence suggests that this dietary intervention could be effective for reducing breast cancer risk?

Research has shown that eating a diet that lowers the body's insulin response might help reduce the risk of breast cancer. This trial will test a low-insulinemic dietary intervention, focusing on foods with these positive effects, such as plant-based proteins, fruits, vegetables, whole grains, and fiber. One study suggested that changing a diet to lower its insulin response can decrease breast cancer risk. Another study found that women who consumed foods that significantly raised their blood sugar levels had a higher risk of dying from breast cancer. Additionally, diets that help prevent insulin resistance and diabetes might also lower breast cancer risk. ^{1 2 6 7 8}

Who Is on the Research Team?

Fred K Tabung, PhD, MSPH

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Prevention (Low-EDIH dietary pattern intervention) Experimental Treatment 6 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.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a preclinical study using a rat model, a low glycemic load diet significantly reduced breast cancer incidence (23.3% vs. 50.0%) and tumor burden compared to a high glycemic load diet, suggesting a protective effect against cancer development.

The protective effect of the low glycemic load diet was linked to changes in cell growth regulation markers, but this effect was diminished when diets were adjusted to isolate specific components like resistant starch, indicating that other dietary factors also play a role in cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of low or high glycemic load diets on experimentally induced mammary carcinogenesis in rats. Thompson, HJ., Neuhouser, ML., Lampe, JW., et al.[2018]

Low glycaemic-index diets can lead to rapid weight loss and improvements in key metabolic markers, including reduced fasting glucose and insulin levels, lower triglycerides, and better blood pressure.

While these short-term benefits are promising, the long-term effects of low glycaemic-index diets on metabolic diseases and cardiovascular risk still require further controlled studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic effects of low glycaemic index diets. Radulian, G., Rusu, E., Dragomir, A., et al.[2023]

A study of 179 older adults found that those following a lower-glycemic-load diet had significantly lower glycemic loads compared to those on a higher-glycemic-load diet, suggesting dietary patterns can influence metabolic health.

Participants in the lower-glycemic-load group consumed more nutrient-dense carbohydrates like whole grains, fruits, and vegetables, indicating that promoting these foods could help reduce the risk of obesity and chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

More favorable dietary patterns are associated with lower glycemic load in older adults. Davis, MS., Miller, CK., Mitchell, DC.[2016]

In a study of 39,876 women over an average of 6.8 years, no overall association was found between high glycemic load (GL) or glycemic index (GI) diets and breast cancer risk, suggesting that these dietary factors may not significantly influence breast cancer development.

However, among premenopausal women with low physical activity, a high glycemic diet was associated with an increased risk of breast cancer, indicating that lifestyle factors may modify the effects of glycemic diets on cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary glycemic load and breast cancer risk in the Women's Health Study. Higginbotham, S., Zhang, ZF., Lee, IM., et al.[2019]

In a study of 63,307 postmenopausal women followed for 5 years, high dietary glycemic index and glycemic load were not linked to an increased risk of breast cancer, suggesting that carbohydrate quality may not significantly influence breast cancer risk.

The research indicates that factors like body mass index, physical activity, and hormone use did not alter the relationship between glycemic index and breast cancer risk, highlighting the need for further studies with longer follow-up and better dietary assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary glycemic index, glycemic load, and risk of incident breast cancer in postmenopausal women. Jonas, CR., McCullough, ML., Teras, LR., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High glycemic diet and breast cancer occurrence in the Italian EPIC cohort. Sieri, S., Pala, V., Brighenti, F., et al.[2016]

In a study of 8,932 women with stage I-III breast cancer, higher postdiagnostic dietary glycemic load (GL) was linked to an increased risk of breast cancer-specific mortality, with a hazard ratio of 1.33, indicating a significant association.

Additionally, higher dietary glycemic index (GI), insulin index (II), and insulin load (IL) were all associated with increased all-cause mortality, suggesting that the quality and quantity of carbohydrates consumed after diagnosis may impact overall survival in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postdiagnostic Dietary Glycemic Index, Glycemic Load, Dietary Insulin Index, and Insulin Load and Breast Cancer Survival. Farvid, MS., Tamimi, RM., Poole, EM., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 12-week controlled feeding trial with 29 obese participants, reducing dietary glycemic load and glycemic index did not lead to greater weight loss compared to other hypocaloric diets, as all groups lost significant weight (around 8.4 to 9.9 kg) without differences among them.

All diet groups showed improved insulin sensitivity by the end of the feeding phase, and these benefits were maintained during a 24-week follow-up, indicating that weight loss and insulin sensitivity improvements were primarily due to calorie restriction rather than diet composition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Raatz, SK., Torkelson, CJ., Redmon, JB., et al.[2023]

A meta-analysis of prospective cohort studies found a modest association between high glycemic index and glycemic load diets and an increased risk of breast cancer, with summary relative risks of 1.05 and 1.06, respectively.

This association remained significant even after adjusting for factors like body mass index, physical activity, and menopausal status, suggesting that dietary patterns may play a role in breast cancer etiology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relation between Breast Cancer and High Glycemic Index or Glycemic Load: A Meta-analysis of Prospective Cohort Studies. Mullie, P., Koechlin, A., Boniol, M., et al.[2022]

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