A Study of Freeze-Dried Miracle Fruit (MiraBurst) on Participants Receiving Cancer Treatment

Официальное название

A Pilot Study to Explore the Effects of Freeze-Dried Miracle Fruit (MiraBurst) on Patients Receiving Cancer Treatment

Обзор

This study is for people with a diagnosis of solid tumor cancer who are experiencing changes in taste perception due to cancer treatment. Changes in taste perception, also known as dysgeusia, is a frequent side effect of cancer treatment and can significantly impacts quality of life. These alterations may be temporary or, in some cases, permanent. The purpose of this study is determine whether freeze dried miracle fruit, marketed as MiraBurst can improve taste perception in this group of people. Participants involved in this study will be asked to take one MiraBurst mini-square upto four times a day, prior to eating, for 90 days.

Подробное описание

Cancer and the treatment of cancer can create many symptoms that impact people's lives. More than 90% of people with cancer have at least one symptom caused by their cancer or treatment. The most common symptoms are related to the gastrointestinal system. Change in sense of taste is the fourth most common symptom and may be described as "food not tasting the same as they use to, food tasting bland, everything tastes the same, or an unpleasant bitter or metallic taste." Change in taste can impact a person's quality of life, but there are not many options to treat this symptom.

The MiraBurst product used in this study comes from a berry fruit harvested in Ghana. The berries are freeze-dried into a powder and pressed into small, square pieces that each weigh 300 mg. The product is made from 100% pure miracle berry powder and has the same natural composition as the fresh berry. It contains no additives or preservatives. The berry is vegan, allergen-free, and gluten-free, and it has no known side effects. During processing, no substances are extracted from the berries except water. This product is not classified as a drug or a dietary supplement and does not contain any active or inactive ingredients. Because it is a pure berry powder, it does not go through a strict standardization process. Both the raw freeze-dried powder and the finished product (MiraBurst Mini Squares) are tested by third-party laboratories for microbial safety in both Ghana and the United States. The powder is also tested for heavy metals and goes through contaminant removal and metal detection during manufacturing. According to the manufacturer, the freeze-dried miracle berry powder is produced in a Good Manufacturing Practice (GMP)-compliant facility in Ghana. The manufacturing and packaging facilities for MiraBurst Mini Squares in the United States (Connecticut and New Jersey) are also GMP-compliant. There are no known interactions between this product and herbs or medications. The product is available over the counter and is commonly used several times a day, up to five times daily-before breakfast, snacks, lunch, and dinner.

Previous studies have shown that supplements made from the same miracle fruit can have promising effects for people with cancer. One pilot study in 2010 found that 30% of people who received miracle fruit for two weeks reported improvements in their taste perception. In another pilot study, all participants who received miracle fruit reported positive changes after two weeks. Participants reported that taste changes such as experiencing a sour or metallic taste improved and that foods tasted sweeter or more pleasant. Yet another study found these similar positive changes, while also finding that participants who received miracle berry also had a higher energy intake, increased fat-free mass, and improved quality of life compared to participants on placebo. Preclinical data on miracle berry extract indicate that it is relatively safe, with no significant toxicity reported. The active component in miracle berry, miraculin, is a glycoprotein that is rapidly and completely digested in the gastrointestinal (GI) tract. This makes systemic absorption and interaction with drug-metabolizing enzymes, such as CYP450 or MAO (monoamine oxidase), highly unlikely. Both in silico and in vitro analyses have demonstrated a low potential for allergenicity or cross-reactivity with other proteins.

This study seeks to confirm the promising and beneficial effects of miracle fruit, with a branded product (MiraBurst), which has appropriate manufacturing controls in place for quality consistency, on symptoms related to dysgeusia (alterations in taste perception).

Вмешательства

• Пищевая добавка MiraBurst
  Participants will consume one 300 milligram (mg) MiraBurst mini-square prior to each meal (up to four times per day) for a 90 day period.

Первичные конечные точки

• Evaluate effect on taste perception [Срок оценки: Baseline (Day 1), Day 7]
• Evaluate effect on taste perception [Срок оценки: Baseline (Day 1), Day 28]
• Evaluate effect on taste perception [Срок оценки: Baseline (Day 1), Day 90]
• Evaluate effect on taste perception [Срок оценки: Baseline (Day 1), Day 120]

Вторичные конечные точки (8)

• Evaluate effect on weight [Срок оценки: Baseline (Day 1), Day 7]
• Evaluate effect on weight [Срок оценки: Baseline (Day 1), Day 28]
• Evaluate effect on weight [Срок оценки: Baseline (Day 1), Day 90]
• Evaluate effect on weight [Срок оценки: Baseline (Day 1), Day 120]
• Evaluate effect on quality of life [Срок оценки: Baseline (Day 1), Day 7]
• Evaluate effect on quality of life [Срок оценки: Baseline (Day 1), Day 28]
• Evaluate effect on quality of life [Срок оценки: Baseline (Day 1), Day 90]
• Evaluate effect on quality of life [Срок оценки: Baseline (Day 1), Day 120]

Критерии участия

Критерии включения

• Age 18 years and above
• Solid tumor cancer diagnosis
• Participants on active cancer treatment
• Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
• Grade 2 dysgeusia related to cancer treatment per Common Terminology Criteria for Adverse Events (CTCAE) version 6.0

Критерии исключения

• Grade 2 dysgeusia prior to starting cancer treatment
• Participants with severe dementia, severe neurological illness who are unable to understand the study or provide informed consent
• Participants on enteral and parenteral nutrition
• Participants with eating disorders
• Pregnancy
• Participants with uncontrolled acute medical issues (e.g., acute angina, acute stroke, uncontrolled diabetes mellitus, uncontrolled hypertension etc.) that, per investigator's assessment, would contraindicate the study treatment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Cleveland Clinic Foundation — Cleveland

Публикации

• Kang D, Kim S, Kim H, Lee M, Kong SY, Chang YJ, Sim SH, Kim YJ, Cho J. Surveillance of Symptom Burden Using the Patient-Reported Outcome Version of the Common Terminology Criteria for Adverse Events in Patients With Various Types of Cancers During Chemoradiation Therapy: Real-World Study. JMIR Public Health Surveill. 2023 Mar 8;9:e44105. doi: 10.2196/44105. PMID 36884274
• Murtaza B, Hichami A, Khan AS, Ghiringhelli F, Khan NA. Alteration in Taste Perception in Cancer: Causes and Strategies of Treatment. Front Physiol. 2017 Mar 8;8:134. doi: 10.3389/fphys.2017.00134. eCollection 2017. PMID 28337150
• Komurcu S, Nelson KA, Walsh D, Ford RB, Rybicki LA. Gastrointestinal symptoms among inpatients with advanced cancer. Am J Hosp Palliat Care. 2002 Sep-Oct;19(5):351-5. doi: 10.1177/104990910201900513. PMID 12269782
• Speck RM, DeMichele A, Farrar JT, Hennessy S, Mao J, Stineman MG, Barg FK. Coping with the burden of taste alteration, a toxicity of taxane-based chemotherapy. J Clin Oncol. 2012;30(15). PubMed PMID: WOS:000318009801842.
• Hiroyuki Otani, Amano K, Morita T, Miura T, Mori N, Tatara R, Kessoku T, Matsuda Y, Tagami K, Mori M, Taniyama T, Nakajima N, Nakanishi E, Kako J, Shirado AN, Yokomichi N, Miyashita M. Impact of taste/smell disturbances on dietary intakes and cachexia-related quality of life in patients with advanced cancer. Support Care Cancer. 2023 Jan 30;31(2):141. doi: 10.1007/s00520-023-07598-6. PMID 36715776
• Lopez-Plaza B, Alvarez-Mercado AI, Arcos-Castellanos L, Plaza-Diaz J, Ruiz-Ojeda FJ, Brandimonte-Hernandez M, Feliu-Batlle J, Hummel T, Gil A, Palma-Milla S. Efficacy and Safety of Habitual Consumption of a Food Supplement Containing Miraculin in Malnourished Cancer Patients: The CLINMIR Pilot Study. Nutrients. 2024 Jun 17;16(12):1905. doi: 10.3390/nu16121905. PMID 38931260
• H. P. Soares MC, M. A. Schwartz, J. F. Pizzolato, J. Lutzky, R. J. Campbell, J. L. Beaumont, D. Eton, S. Stonick, and R. Lilenbaum. Treatment of taste alterations in chemotherapy patients using the "miracle fruit": preliminary analysis of a pilot study. American Society of Clinical Oncology. 2010
• Satiroff MKWaBA. Pilot Study of

Идентификаторы

NCT: NCT07419581 · CASE4Y25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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