mBerry for Taste Disturbance

Overseen By Ashley Traeger

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Florida

Must not be taking: Metformin

Disqualifiers: Diabetes, Prediabetes, Glossectomy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests mBerry tablets to address taste issues in head and neck cancer patients undergoing radiation therapy. The goal is to determine if mBerry can enhance taste, making meals more enjoyable and helping patients maintain better nutrition. Participants will either take mBerry tablets daily for two meals or join a group that does not take mBerry, with both groups undergoing regular taste check-ups. This trial suits adults with specific head or neck cancers who are currently receiving radiation therapy and have not undergone major surgeries like a total glossectomy (removal of the tongue). As an unphased trial, this study provides a unique opportunity to explore a potential new way to improve quality of life during treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking Metformin, you cannot participate.

What prior data suggests that mBerry is safe for use in head and neck cancer patients?

Research has shown that mBerry, derived from the miracle berry, is generally safe for people. In a small study with 23 patients experiencing taste problems from chemotherapy, consuming this berry proved safe, with no major side effects reported.

Although the FDA has not approved mBerry for treating taste issues from radiation, it has been used safely in other contexts. Researchers are investigating its potential to improve taste after radiation therapy in cancer patients.

Overall, early studies suggest that mBerry is well-tolerated, meaning most people can take it without issues. However, as with any treatment, monitoring for any unusual reactions is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about mBerry for taste disturbances because it offers a natural, fruit-derived solution that could be more appealing to patients than traditional synthetic treatments. Unlike standard care options that might focus on altering taste perception through chemical means, mBerry works by using miraculin, a glycoprotein found in the miracle fruit, which temporarily changes the way taste receptors interpret sour and bitter flavors, making them taste sweet instead. This unique approach not only provides a novel mechanism of action but also offers a safer, non-invasive alternative that could enhance the eating experience for those with taste disturbances.

What evidence suggests that mBerry might be an effective treatment for dysgeusia?

Research shows that the miracle berry, or mBerry, can enhance flavor enjoyment for those with taste problems. In this trial, participants in the experimental group will receive mBerry tablets. One study found that patients taking a food supplement made from miraculin, like mBerry, reported improved taste experiences. Another study discovered that people using mBerry could taste flavors more clearly over time. Additionally, patients often noticed positive changes in their taste after using miracle fruit. These findings suggest mBerry might improve taste for individuals with altered taste following cancer treatments. ^{1 3 6 7 8}

Who Is on the Research Team?

Jennifer Larsson

Principal Investigator

University of South Florida

Are You a Good Fit for This Trial?

This trial is for adults over 18 with mandibular, tonsillar, or lingual cancer who are undergoing primary or adjuvant radiation therapy. It's designed to help those experiencing taste disturbances (dysgeusia) due to their treatment.

Inclusion Criteria

I have been diagnosed with cancer in my jaw, tonsils, or tongue.

I am over 18 years old.

I am currently undergoing radiation therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo radiation therapy as part of their standard cancer treatment

Varies

Treatment

Participants receive mBerry tablets twice daily for 8 weeks to manage dysgeusia

8 weeks

Bi-weekly taste assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• mBerry

Trial Overview The study tests the effects of mBerry on managing dysgeusia in head and neck cancer patients receiving radiation. Participants will either use mBerry or receive no intervention to see if it improves life quality and nutritional outcomes.

How Is the Trial Designed?

Group I: Experimental group given mBerry tablet Experimental Treatment 1 Intervention

For the experiment group, the clinician will be providing participant with daily 0.4 gram mBerry tablets (total of 112 tablets) to consume twice a day (for two meals) over an 8-week period. The participant will be provided with a log form to track mBerry use for the two meals each day for the 8-week period. They will be requested to bring log to each of the clinical visits which include bi-weekly taste assessments.

Group II: Control group not receiving mBerry Active Control 1 Intervention

The control group will not be given a placebo. The control group will come to clinic for bi-weekly taste assessments.

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38931260/

Efficacy and Safety of Habitual Consumption of a Food ... Patients consuming a standard dose of DMB exhibited improved taste acuity over time (% change right/left side: -52.8 ± 38.5/-58.7 ± 69.2%) and ...

2. withpower.com withpower.com/trial/phase-dysgeusia-4-2024-65dc9

mBerry for Taste Disturbance · Info for Participants Some studies suggest that zinc therapy can help improve taste disturbances, with about one-third of patients responding to it. While mBerry is not zinc, this ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37960292/

Effect of Regular Consumption of a Miraculin-Based Food ... Malnourished cancer patients with taste distortion who consume the miraculin-based food supplement will report an improvement in food taste perception.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06311877?cond=%22Dysgeusia%22&viewType=Table&rank=1

Effects of Flavor Modification for Management of Radiation ... It is being used as part of this research study to find out if mBerry tablets improve taste outcomes among head and neck cancer patients after radiation therapy ...

5. medrxiv.org medrxiv.org/content/10.1101/2024.05.15.24307453v1.full

Efficacy and Safety of Habitual Consumption of a Food ... At the end of the study, all patients reported positive taste changes with miracle fruit consumption through qualitative data.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10648678/

Effect of Regular Consumption of a Miraculin-Based Food ... A pilot clinical trial involving 23 patients with dysgeusia derived from chemotherapy treatment demonstrated that the consumption of this berry was safe, and 30 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6108391/

Flavor Alterations Associated with Miracle Fruit and Gymnema ... In this study, multiple regression showed that both sweet and sour contribute to flavor. Gymnema sylvestre reduced the perceived sweet of ...

8. science.food.gov.uk science.food.gov.uk/article/131823-safety-assessment-of-dried-miracle-berry-_synsepalum-dulcificum_-as-a-novel-food-for-use-in-food-and-food-supplements-rp1351

Safety Assessment of Dried Miracle Berry (Synsepalum ... This new application is seeking to use the novel food as a functional food supplement to modify the taste of sour foods due to the presence of miraculin.