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Clinical Trials/NCT02949102
NCT02949102CompletedNot Applicable

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

Oregon Research Behavioral Intervention Strategies, Inc.0 sites40 target enrollmentStarted: December 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Primary Endpoint
fMRI responses to high-sugar food tastes and food cues

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Crave Crush

Experimental

Crave Crush is a plant-based tablet that alters taste perception by affecting sweet taste receptors on the tongue.

Intervention: Crave Crush (Dietary Supplement)

Placebo

Placebo Comparator

The placebo tablet is comparable in taste and is comprised primarily of sorbitol.

Intervention: Placebo (Dietary Supplement)

Outcomes

Primary Outcomes

fMRI responses to high-sugar food tastes and food cues

Time Frame: 13 minutes

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.

Secondary Outcomes

  • candy consumption(15 minutes)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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