Effects of Miracle Fruit Pill Application on Food Likings and Energy Intake in Diabetic or Prediabetic Patients
Completed · Not applicable · Has a placebo group
Conditions studied: Diabetes, PreDiabetes
In brief
The high prevalence of diabetes and prediabetes has increased the demand for nonnutritive sweeteners in recent years. Miracle fruit has been considered a healthy alternative sweetener for diabetic patients due to its sweetness-enhancing effects and high antioxidant activity. The purposes of this study are to examine whether the miracle fruit pill application to mouth prior to food consumption could improve the likings of different types of sour food (green apple, goat cheese, lemonade, cucumber pickle, and plain fat-free yogurt) and meals (breakfast, lunch, and dinner), and reduce energy intakes at the meals. Fifty volunteers (25 men and 25 women) aged 45 to 75 years with diabetes or prediabetes participate in the study. In this study, two interventions (miracle fruit and placebo) are provided, and all participants receive both applications. Participants are randomly assigned to one of the two interventions in part 1 and the assignment is switched from one application to another in part 2. The study hypotheses of this study are that the miracle fruit intervention improves the likings for sour foods and meals more than the placebo does; The miracle fruit intervention also reduces energy intakes from the meals more than the placebo does. Participants are asked to participate in a total of 6 sessions (1 hour/session, 1 session/day, Part 1: session 1, 2, \& 3, Part 2: session 4, 5, \& 6). Each session consists of two 30-min assessments, which are liking tests and meal intake assessment. The potential participants who have known food allergies or food intolerances are screened through consented screening procedure. If unknown food allergies or intolerances unintentionally become present during the study, medical help will be sought immediately. Participants may enjoy food samples and meals provided in this study and benefit by learning more about their acceptances for miracle fruit pill as an alternative sweetener. The results of this research are expected to develop generalizable knowledge about the miracle fruit's potential to improve the food palatability for people with diabetes or prediabetes.
Key facts
- Study ID
- NCT05468411
- Run by
- Queens College, The City University of New York
- People needed
- 54
- Starts
- 2019-11-01
- Expected to finish
- 2020-12-31
- Last updated by the study team
- 2022-09-15
Who can join
Age: 45 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Having a score of 5 or higher on the 'Prediabetes Risk Test' provided by the American Diabetes Association and the Centers for Disease Control and Prevention
- Having been diagnosed with prediabetes or diabetes by doctor
You may not qualify if…
- Smoking
- Having food allergies or food intolerances
- Being diagnosed with taste disorders
- Being pregnant
- Breastfeeding
- Using medications that could affect taste perception and food intake
Where it is running
- Korean Community Services of Metropolitan New York, Inc. — Bayside, New York, United States
Full record on ClinicalTrials.gov
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