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Diet that lowers insulin may cut breast cancer risk

NCT ID NCT06635005

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested whether a diet designed to lower insulin levels could reduce breast cancer risk in 34 high-risk women. The diet is rich in fruits, vegetables, whole grains, and plant protein, and low in animal protein and fat. The main goal was to see if women could stick to the diet, not yet to measure cancer outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Low-insulinemic dietary pattern
What this could lead to
If successful, this diet could offer a practical way to lower breast cancer risk in high-risk women without medication.
What could go wrong
This is a small pilot study (34 women) testing feasibility, not effectiveness. The diet is complex and may be hard to follow long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

34 people

The number who actually took part.

Started

Oct 2024

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

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