Effects of Miracle Fruit Pill Application on Food Likings and Energy Intake in Diabetic or Prediabetic Patients

NCT05468411 | Completed

• 1 other identifier: PSC-CUNY 62192-00-50
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes; PreDiabetes

Keywords

Miracle fruit; Alternative sweetener; Taste liking; Energy intake; Placebo

Outcome Measures

Primary Outcomes (3)

• Changes in food liking from pre- to post-intervention

  Changes in food liking for sour food samples (green apple, goat cheese, lemonade, cucumber pickle, and plain fat-free yogurt) are measured by comparing pre-and post-liking scores for sour food samples. Before the intervention (oral application of miracle fruit pill or placebo sugar candy) is applied, the pre-liking is assessed by tasting each food sample. After the pre-liking test is done, the intervention is applied. It takes approximately 5 minutes for intervention pills (miracle fruit pill or sugar candy) to dissolve. After the oral application/intervention is completed, the post-liking is assessed in the same way as the pre-liking. The pre- and post-likings for overall, flavor, texture, and aftertaste are evaluated using a 9-point hedonic scale (1=dislike extremely, 9=like extremely). For "aftertaste pleasantness", the 'no aftertaste detected' answer option is additionally provided.

  The pre-liking test (10 minutes),intervention application & break (10 minutes), and post-liking test (10 minutes) are conducted consecutively and completed within a session.

• Energy intake from meals

  All foods and beverages that are served to each participant at the meal sessions are preweighed, and food intake is assessed by measuring their remaining food and beverages. The energy intake of each participant is calculated using the food weight on an online nutrient analysis site.

  Each participant's food intake is measured for 30 minutes.

• Overall liking for meals

  Overall liking for each of meals (breakfast, lunch, and dinner) is evaluated using a 9-point hedonic scale (1=dislike extremely, 9=like extremely).

  Immediately after the energy intake measurement is done, overall liking for each meal is evaluated.

Study Arms (2)

Miracle fruit pill

ACTIVE COMPARATOR

A freeze-dried miracle fruit pill is orally administered prior to eating food samples.

Other: Oral application of miracle fruit pill; Other: Oral application of sugar candy

Sugar candy

PLACEBO COMPARATOR

A chewable sugar candy is orally administered as a placebo prior to eating food samples.

Other: Oral application of miracle fruit pill; Other: Oral application of sugar candy

Interventions

Oral application of miracle fruit pill OTHER

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.

Miracle fruit pill; Sugar candy

Oral application of sugar candy OTHER

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.

Miracle fruit pill; Sugar candy

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Queens College, The City University of New York: lead

Study Sites (1)

Korean Community Services of Metropolitan New York, Inc.

Bayside, New York, 11361, United States

Location

Related Publications (1)

• Choi S, Park T. Feasibility and acceptability of miracle fruit application prior to the consumption of sour-tasting foods as a weight-loss strategy in adults with diabetes or prediabetes: A randomized crossover trial. Appetite. 2023 Dec 1;191:107046. doi: 10.1016/j.appet.2023.107046. Epub 2023 Sep 17.

  PMID: 37726068 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Prediabetic State

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sungeun Choi, PhD

  Queens College, CUNY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The taste modifying function of miracle fruit as a sweetness enhancer is masked. Participants are told that they are participating in a study developing a dietary supplement for diabetic patients.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 21, 2022
• Study Start: November 1, 2019
• Primary Completion: February 28, 2020
• Study Completion: December 31, 2020
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 6 months after article publication and the data will be available for up to 12 months
• Access Criteria: Data obtained through this study may be provided to qualified researchers engaging in independent scientific research. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. For more information or to submit a request, please contact Dr. Sungeun choi (sungeun.choi@qc.cuny.edu).

Locations

US (1)