MiraBurst for Taste Disturbance

ST
Overseen ByShirley Thomas, MD, MRCP (UK), MRCP (UK) Pall Med, PGDip Pall Med
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if MiraBurst, a freeze-dried miracle fruit, can improve taste changes caused by cancer treatment. Many individuals with solid tumor cancers experience taste disruptions during treatment, affecting their quality of life. Participants will consume a MiraBurst mini-square before meals for 90 days to test its effectiveness. This trial targets those currently receiving cancer treatment, diagnosed with a solid tumor, and experiencing taste changes due to their treatment. As an unphased trial, it offers a unique opportunity to explore a potential solution for improving taste and enhancing quality of life during cancer treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that MiraBurst is safe for improving taste perception in cancer patients?

Studies have shown that MiraBurst, derived from freeze-dried miracle fruit, is generally safe for people. Research indicates that consuming this fruit does not lead to major health problems. In a small trial with 23 patients experiencing taste changes from chemotherapy, the berry proved safe. Another study demonstrated that the active ingredient, miraculin, did not cause significant harm in early tests.

Although MiraBurst is not FDA-approved specifically for taste issues from treatments, these studies suggest it is well-tolerated. Participants in various studies did not report major side effects, and no significant changes in important health measures were observed. This suggests that MiraBurst is likely safe for short-term use to help with taste changes.12345

Why are researchers excited about this trial?

MiraBurst is unique because it uses the active ingredient miraculin, a glycoprotein found in miracle berries, which can temporarily alter taste perceptions, making sour or metallic tastes seem sweet. This is particularly exciting for those experiencing taste disturbances, as current options are limited and often involve dietary adjustments or zinc supplements. Researchers are enthusiastic about MiraBurst because it offers a natural, non-invasive alternative that could significantly improve quality of life for affected individuals, enhancing their eating experience without the need for additional medications.

What evidence suggests that MiraBurst might be an effective treatment for taste disturbance?

Studies have shown that miraculin, the active ingredient in MiraBurst, can alter flavor perception. It makes sour foods taste less sour and sweet foods taste sweeter, potentially helping cancer patients enjoy their meals more. Research also suggests that regular consumption of miraculin can alter oral bacteria, possibly improving taste for cancer patients. Additionally, miraculin may reduce inflammation and enhance nutrition for those with taste issues. These findings suggest that MiraBurst, which participants in this trial will consume, could help individuals with taste changes due to cancer enjoy their meals more and possibly improve their quality of life.24567

Who Is on the Research Team?

ST

Shirley Thomas, MD, MRCP (UK), MRCP (UK) Pall Med, PGDip Pall Med

Principal Investigator

Case Comprehensive Cancer Center, Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults (18+) with solid tumor cancer who are currently receiving treatment and have moderate taste changes (dysgeusia) caused by their therapy. Participants need to be in reasonably good physical condition.

Inclusion Criteria

I am 18 years old or older.
I am fully active or can care for myself with little help.
I have been diagnosed with a solid tumor cancer.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume one MiraBurst mini-square prior to each meal (up to four times per day) for a 90 day period

12 weeks
Regular self-administration

Follow-up

Participants are monitored for changes in taste perception and quality of life

4 weeks
Final assessment at Day 120

What Are the Treatments Tested in This Trial?

Interventions

  • MiraBurst

Trial Overview

The study tests whether freeze-dried miracle fruit tablets (MiraBurst), taken up to four times daily before meals for 90 days, can help improve taste problems in people undergoing cancer treatment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: MiraBurstExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials
472
Recruited
33,400+

Citations

Effect of Regular Consumption of a Miraculin-Based Food ...

Taste disorders are common among cancer patients undergoing chemotherapy, with a prevalence ranging from 20% to 86%, persisting throughout treatment.

Miraculin Can Contribute to a Reduction in Inflammatory ...

Miraculin can contribute to a reduction in inflammatory biomarkers and cachexia in malnourished patients with cancer and taste disorders.

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39410033/

Effect of a Novel Food Rich in Miraculin on the Oral ...

Conclusions: Accordingly, regular DMB consumption could modify the oral microbiome in patients with cancer and dysgeusia, which may contribute ...

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 ...

Effects of Miracle Fruit Doses on Modifying the Tastes ...

This pilot study investigated the taste‐modifying effects of three doses of miracle fruit tablets (175, 350, and 700 mg) on solutions and foods ...

Efficacy and Safety of Habitual Consumption of a Food ... - PMC

Additionally, DMB consumption appears to be safe, with no changes in major biochemical parameters associated with health status. Clinical trial registered ( ...

MiraBurst for Taste Disturbance · Info for Participants

This study is for people with a diagnosis of solid tumor cancer who are experiencing changes in taste perception due to cancer treatment.