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Berry lozenges may shield Smokers' DNA

NCT ID NCT04372914

Disease control Sponsor: Milton S. Hershey Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether black raspberry lozenges could reduce DNA damage in mouth cells caused by smoking. 69 adult smokers took the lozenges for several weeks. The goal was to see if the berries could lower harmful chemical markers linked to oral cancer. Results may help find a simple way to reduce smoking-related health risks.

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

69 people

The number who actually took part.

Started

Oct 2021

Finished

Dec 2024

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

21 to 75 years

Sex

Anyone

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 21-75 * Smoke 5 cigarettes per day or more for at least the past 12 months * Have an expired air carbon monoxide measurement of greater than 6 parts per million * No serious quit attempt in the last one month and not planning to quit in the next 4 months * Willing and able to attend all study visits * Able to read and write in English * Able to understand and provide consent to the study procedures * Willingness and ability to attend regular visits over a 14-week period and to respond to research contacts between the 5 Exclusion Criteria: * Unstable or significant medical conditions that affect participant safety or biomarker data in the past 3 months (e.g. recent heart attack, asthma or COPD) * Women currently pregnant or nursing * Use of any non-cigarette nicotine delivery product in the past 7 days (e.g. e-cigarettes, pipe or cigar) * Uncontrolled mental illness or inpatient treatment in the past 6 months; current suicide risk on clinical assessment * Any known allergy to raspberries * Use of marijuana or other illegal drugs daily or weekly in the past 3 months * Use of high dose antioxidant supplements in the past month * Use of antibiotics * Heavy drinking (\>4 drinks/day, 5 days/week) * Made no serious cigarette smoking quit attempt or have used any FDA-approved smoking cessation medication in the prior 30 days * No plan to quit smoking within the next 4 months

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Conditions

The condition(s) this trial relates to.

lip and oral cavity carcinoma Mouth Neoplasms Smoking

As listed by the trial registrant

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

DNA damage Oral cancer Oxidative stress Smoking

Contacts and locations

Locations

  • Penn State CTSI Clinical Research Center

    Hershey, Pennsylvania, 17033, United States

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