Effects of Miracle Fruit Pill Application on Food Likings and Energy Intake in Diabetic or Prediabetic Patients
Condition: Diabetes; PreDiabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      Due to the rise in rates of obesity and diabetes in recent years, the consumer demand for
      alternative sweetener is growing especially among people with diabetes or prediabetes. Given
      the need for alternative sweeteners, miracle fruit (Synsepalum dulcificum) may be a good
      candidate to fulfill the demand. Miracle fruit has been used as a sweet enhancer for
      thousands of years by the natives in Western Africa without any reports of adverse effects.
      The red, cranberry-sized miracle fruit is named for its unique ability to transform sour
      taste into sweet. In addition to the miracle fruit's taste modification function, miracle
      fruit has valuable antioxidant activities that can be applied for functional food and has
      also been studied to improve insulin resistance induced by fructose-rich chow in rats. With
      the potential health benefit of miracle fruit, miracle fruit has been considered as a healthy
      alternative sweetener that can meet diabetic patients' needs. However, for the practical
      applications of miracle fruit for diabetic diet, the acceptability of miracle fruit and its
      effect on energy intake need to be examined among diabetic patients. Fresh miracle fruits are
      highly perishable, and they cannot be cooked because the taste modifying effect found in the
      pulp of the miracle fruit is due to a protein, which is deactivated by heat. For these
      reasons, a freeze-dried pill form of miracle fruit needs to be applied on a tongue to coat
      taste buds before food is consumed. Therefore, in this study, the effects of oral application
      of miracle fruit pill are compared with placebo (sugar candy) on the likings of different
      sour food products (green apple, goat cheese, lemonade, cucumber pickle, and plain fat-free
      yogurt) and meals (breakfast, lunch, and dinner), and energy intakes from the meals in people
      with diabetes or prediabetes. A total of 50 patients aged 45 to 75 years who have been
      diagnosed with diabetes or prediabetes (25 men and 25 women) participate in this study. They
      should be nonsmokers; not have food allergies or food intolerances; not be diagnosed with
      taste disorders; not be pregnant; not breastfeed; and not use medications that could affect
      taste perception and food intake. This study is a randomized placebo-controlled crossover
      trial. As an intervention, a miracle fruit pill is orally administered prior to eating food
      samples. The same protocol is followed in the control group but with placebo (sugar candy).
      Participants are asked to participate in a total of six 1-hour sessions (1 session/day).
      Participants are randomly assigned to either of two applications (miracle fruit and placebo)
      in part 1 and one week after part 1 (1-week washout), their intervention assignment is
      switched from one application to another in part 2. Each part/intervention consists of 3
      sessions and each session consists of two assessments (liking tests and meal intake
      assessment). In each part/intervention, each participant performs the liking tests for five
      sour foods in triplicate and consumes breakfast, lunch, and dinner meals once. The order of
      the experiments in each session is as follows: 1. preliking test; 2. miracle fruit
      pill/placebo administration; 3. postliking test; and 4. meal intake. At the liking tests, the
      pre- and postlikings of overall, flavor, texture, and aftertaste for all 5 sour food samples
      are assessed using a 9-point hedonic scale (1=dislike extremely, 9=like extremely). For the
      meal intake assessment, standardized breakfast, lunch, and dinner meals are provided to
      participants according to the experimental design. During the meal intake session,
      participants are allowed to consume any food, beverage, or condiments, including sweeteners
      that are provided at the session. All foods and beverages that are consumed by each
      participant at the meals are weighed, and the energy intakes from the meals are calculated
      using the food weight via online nutrient tracker.
    

Intervention name(s): Oral application of miracle fruit pill; Oral application of sugar candy
Intervention type(s): Other; Other
Intervention description(s): Miracle fruit has a taste modifying function from sourness to sweetness when it is exposed to an acidic environment. To activate the miracle fruit's function, a miracle fruit pill should be orally administered to coat taste buds prior to eating sour food. Thus, participants are instructed to place a miracle fruit pill is on their tongue, and roll the pill around their mouth to allow full contact of the pill with the surface of the oral cavity without chewing until the pill completely dissolved. A miracle fruit pill is administered prior to eating.; To simulate the miracle fruit's function as a placebo, a chewable sugar candy that has a similar appearance to miracle fruit pill is orally administered. The same protocol that is used in miracle fruit intervention is followed in this placebo intervention but with a chewable sugar candy. Participants are instructed to place a sugar candy is on their tongue, and roll the candy around their mouth to allow full contact of the candy with the surface of the oral cavity without chewing until the candy completely dissolved. A sugar candy is administered prior to eating.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study is a randomized crossover trial that has two interventions (miracle fruit pill and placebo). This means that participants have a 100% chance of getting both applications.
Participants are asked to participate in a total of six sessions (Part 1: session 1, 2, & 3, Part 2: session 4, 5, & 6). Participants are randomly assigned to either of two interventions (miracle fruit and placebo) in part 1 and their assignment are switched from one application to another in part 2.
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Miracle fruit; Alternative sweetener; Taste liking; Energy intake; Placebo