Effects of Miracle Fruit Pill Application on Food Likings and Energy Intake in Diabetic or Prediabetic Patients
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ClinicalTrials.gov Identifier: NCT05468411 |
Recruitment Status :
Completed
First Posted : July 21, 2022
Last Update Posted : September 15, 2022
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Condition or disease | Intervention/treatment | Phase |
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Diabetes PreDiabetes | Other: Oral application of miracle fruit pill Other: Oral application of sugar candy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 54 participants |
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) |
Masking Description: | 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. |
Primary Purpose: | Supportive Care |
Official Title: | Effects of Oral Application of Miracle Fruit Pill Before Eating Food on Food Likings and Energy Intake in Diabetic or Prediabetic Patients: A Randomized Crossover Trial |
Actual Study Start Date : | November 1, 2019 |
Actual Primary Completion Date : | February 28, 2020 |
Actual Study Completion Date : | December 31, 2020 |
Arm | Intervention/treatment |
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Active Comparator: Miracle fruit pill
A freeze-dried miracle fruit pill is orally administered prior to eating food samples.
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Other: Oral application of miracle fruit pill
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. Other: Oral application of sugar candy 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. |
Placebo Comparator: Sugar candy
A chewable sugar candy is orally administered as a placebo prior to eating food samples.
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Other: Oral application of miracle fruit pill
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. Other: Oral application of sugar candy 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. |
- Changes in food liking from pre- to post-intervention [ Time Frame: 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. ]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.
- Energy intake from meals [ Time Frame: Each participant's food intake is measured for 30 minutes. ]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.
- Overall liking for meals [ Time Frame: Immediately after the energy intake measurement is done, overall liking for each meal is evaluated. ]Overall liking for each of meals (breakfast, lunch, and dinner) is evaluated using a 9-point hedonic scale (1=dislike extremely, 9=like extremely).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 45 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05468411
United States, New York | |
Korean Community Services of Metropolitan New York, Inc. | |
Bayside, New York, United States, 11361 |
Principal Investigator: | Sungeun Choi, PhD | Queens College, CUNY |
Responsible Party: | Queens College, The City University of New York |
ClinicalTrials.gov Identifier: | NCT05468411 |
Other Study ID Numbers: |
PSC-CUNY 62192-00-50 |
First Posted: | July 21, 2022 Key Record Dates |
Last Update Posted: | September 15, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | All collected IPD in a publication. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (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). |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Miracle fruit Alternative sweetener Taste liking Energy intake Placebo |
Prediabetic State Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |