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 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.

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.

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. ^{1 2 3 4 5}

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. ^{5 6 7 8 9}

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. ^{5 6 7 10 11}

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

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 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]

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 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 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 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]

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 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]

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 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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Glycemic index, glycemic load and invasive breast cancer incidence in postmenopausal women: The PREDIMED study. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

High glycemic diet and breast cancer occurrence in the Italian EPIC cohort. [2016]

3. England 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Dietary glycemic index, glycemic load, and risk of incident breast cancer in postmenopausal women. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Postdiagnostic Dietary Glycemic Index, Glycemic Load, Dietary Insulin Index, and Insulin Load and Breast Cancer Survival. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Effect of low or high glycemic load diets on experimentally induced mammary carcinogenesis in rats. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

More favorable dietary patterns are associated with lower glycemic load in older adults. [2016]

8. United States 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. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Metabolic effects of low glycaemic index diets. [2023]

10. United States pubmed.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 States pubmed.ncbi.nlm.nih.gov

Dietary glycemic load and breast cancer risk in the Women's Health Study. [2019]