Crave Crush Neuroimaging Study

Effects of Gymnemic Acids Lozenge on Reward Region Response to Receipt and Anticipated Receipt of High-Sugar Food, High-Sugar Food Pictures, and Ad Lib Candy Intake

The purpose of the research is to test whether a gymnemic acids (GA) lozenge will reduce reward region response to intake of high-sugar food and ad lib candy intake and whether the GA lozenge reduced reward region response to anticipated intake of high-sugar food and high-sugar food pictures relative to a placebo lozenge.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Crave Crush; Dietary supplement: Placebo

Detailed Description

Test the hypothesis that an acute dose of Crave Crush will produce greater reductions in reward region response to a taste of a high-sugar/high-fat beverage and anticipated receipt of this beverage than a placebo dose.

Test the hypothesis that a dose of Crave Crush will result in reduced ad lib candy intake while the participants complete a survey after the fMRI scan. Participants will receive a second dose of Crave Crush or placebo. They will then be placed in a room to complete a few surveys. A bowl of candy will be placed on the table. Participants will be told that the candy is left over from their assessment and that they are free to have as much as they like, because the candy must be discarded after each participant.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Between 18 and 50 years old
• report having a sweet tooth
• report desire to lose weight
• Body Mass Index between 18 and 40

Exclusion Criteria:

• major psychiatric disorders
• serious health problems (e.g., diabetes)
• habitual use of psychoactive drugs or medications
• contraindications for MRI scanning (e.g., ferromagnetic braces)
• gluten or lactose intolerance
• a vegan diet.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Crave Crush; Crave Crush is a plant-based tablet that alters taste perception by affecting sweet taste receptors on the tongue.	Dietary supplement: Crave Crush; Crave Crush is a dietary supplement that affects sweet taste receptors on the tongue.
Placebo Comparator: Placebo; The placebo tablet is comparable in taste and is comprised primarily of sorbitol.	Dietary supplement: Placebo; The placebo tablet is comparable in taste and is comprised primarily of sorbitol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fMRI responses to high-sugar food tastes and food cues	Blood oxygen dependent signal (BOLD) response in exposure to intake of high-sugar food and food cues will be measured during a fMRI scan to test whether the GA lozenge produces greater reductions in activity in reward-related brain regions relative to a placebo lozenge.	13 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
candy consumption	The current study tested whether the GA lozenge reduces ad lib candy intake relative to a placebo lozenge.	15 minutes

Collaborators and Investigators

• Sponsor: Oregon Research Behavioral Intervention Strategies, Inc.
• Collaborators: Cravecrush; Oregon Behavioral Intervention Strategies, Inc.
• Investigators: Principal Investigator: Eric Stice, Ph.D., Oregon Research Behavioral Intervention Strategies

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: October 26, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): October 31, 2016

Study Record Updates

• Last Update Posted (Actual): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: FOUR002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO