NCT02949102

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

6 months

First QC Date

October 26, 2016

Last Update Submit

July 17, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • candy consumption

    15 minutes

Study Arms (2)

Crave Crush

EXPERIMENTAL

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

Dietary Supplement: Crave Crush

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Crave CrushDIETARY_SUPPLEMENT

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

Crave Crush
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eric Stice, Ph.D.

    Oregon Research Behavioral Intervention Strategies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2016

First Posted

October 31, 2016

Study Start

December 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 19, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share