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Completed

NCT Number: NCT02949102

Crave Crush Neuroimaging Study

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Crave Crush

Dietary Supplement

Crave Crush is a dietary supplement that affects sweet taste receptors on the tongue.

Placebo

Dietary Supplement

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

Primary outcomes

  1. 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

  1. candy consumption

    Time frame: 15 minutes

    The current study tested whether the GA lozenge reduces ad lib candy intake relative to a placebo lozenge.

Sponsors and collaborators

Lead sponsor

Oregon Research Behavioral Intervention Strategies, Inc.

Industry

Collaborators

  • Cravecrush
  • Oregon Behavioral Intervention Strategies, Inc.

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 31, 2016
Registry last updated
Jul 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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