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Crave Crush Behavioral Study

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ClinicalTrials.gov Identifier: NCT02744885
Recruitment Status : Completed
First Posted : April 20, 2016
Last Update Posted : July 19, 2018
Sponsor:
Collaborators:
Cravecrush
Oregon Behavioral Intervention Strategies, Inc.
Information provided by (Responsible Party):
Oregon Research Behavioral Intervention Strategies, Inc.

Tracking Information
First Submitted Date  ICMJE April 18, 2016
First Posted Date  ICMJE April 20, 2016
Last Update Posted Date July 19, 2018
Study Start Date  ICMJE February 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2016)
Self-Reported Craving Reduction [ Time Frame: 10 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2016)
Self-Reported Palatability Reduction [ Time Frame: 10 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Crave Crush Behavioral Study
Official Title  ICMJE Crave Crush: Sugar Cravings and ad Lib Candy Uptake
Brief Summary The purpose of the research is to determine if participants who take "Crave Crush" will report lower cravings and palatability ratings of candy as compared to subjects who receive the placebo. Participants are self-selected university students who pass our table and verbally agree to participate in a research study about taste preferences. Data will be recorded anonymously.
Detailed Description

When students approach the table, research assistants will ask them to choose their favorite kind of candy from an assortment. They will ask the subjects to rate their craving for the candy before they taste it. After they try the candy, the research assistants will ask them to rate its palatability. Then they will rate their craving for another piece of candy. A research assistant will flip a coin to determine whether the subject will receive Crave Crush or placebo. While the Crave Crush or placebo is dissolving in the mouth, the students will fill out a short questionnaire with an identification number. The questionnaire will ask for their age, gender, ethnicity, approximate height and weight, and a few questions about their dietary habits.

After the tablet dissolves, research assistants will ask the students to rate their craving for another piece of candy. Research assistants will ask participants if they would like another piece of candy and have them assess palatability again. The process of offering a piece of candy and asking subjects to rate palatability will occur up to five times. Finally, subjects will be asked if they would like to take a few pieces of candy for the road and if they say yes, the number of pieces they take with them will be noted. The study activities should last no more than 5-10 minutes per participant.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Obesity
Intervention  ICMJE
  • Dietary Supplement: Crave Crush
    Crave Crush is a dietary supplement that affects sweet taste receptors on the tongue.
  • Dietary Supplement: Placebo Comparator: Placebo
    The placebo tablet is comparable in taste and is comprised primarily of sorbitol.
Study Arms  ICMJE
  • Experimental: Crave Crush
    Crave Crush is a plant-based tablet that alters taste perception by affecting sweet taste receptors on the tongue.
    Intervention: Dietary Supplement: Crave Crush
  • Placebo Comparator: Placebo
    The placebo tablet is comparable in taste and is comprised primarily of sorbitol.
    Intervention: Dietary Supplement: Placebo Comparator: Placebo
Publications * Stice E, Yokum S, Gau JM. Gymnemic acids lozenge reduces short-term consumption of high-sugar food: A placebo controlled experiment. J Psychopharmacol. 2017 Nov;31(11):1496-1502. doi: 10.1177/0269881117728541. Epub 2017 Sep 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2016)
67
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • University student, having eaten within the last hour, having slept within two hours of their normal amount

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02744885
Other Study ID Numbers  ICMJE FOUR001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Oregon Research Behavioral Intervention Strategies, Inc.
Study Sponsor  ICMJE Oregon Research Behavioral Intervention Strategies, Inc.
Collaborators  ICMJE
  • Cravecrush
  • Oregon Behavioral Intervention Strategies, Inc.
Investigators  ICMJE Not Provided
PRS Account Oregon Research Behavioral Intervention Strategies, Inc.
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP