Crave Crush Neuroimaging Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Crave Crush
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |