ObesityNCT02744885
Crave Crush Behavioral Study
A study testing Crave Crush in people with Obesity, run by Oregon Research Behavioral Intervention Strategies, Inc..
Trial summary
The purpose of the research is to determine if participants who take "Crave Crush" will report lower cravings and palatability ratings of candy as compared to subjects who receive the placebo. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Crave Crush
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- University student, having eaten within the last hour, having slept within two hours of their normal amount
Who cannot join
- -
About this study
Official title: Crave Crush: Sugar Cravings and ad Lib Candy Uptake
The purpose of the research is to determine if participants who take "Crave Crush" will report lower cravings and palatability ratings of candy as compared to subjects who receive the placebo. Participants are self-selected university students who pass our table and verbally agree to participate in a research study about taste preferences. Data will be recorded anonymously.
Read the detailed description
When students approach the table, research assistants will ask them to choose their favorite kind of candy from an assortment. They will ask the subjects to rate their craving for the candy before they taste it. After they try the candy, the research assistants will ask them to rate its palatability. Then they will rate their craving for another piece of candy. A research assistant will flip a coin to determine whether the subject will receive Crave Crush or placebo. While the Crave Crush or placebo is dissolving in the mouth, the students will fill out a short questionnaire with an identification number. The questionnaire will ask for their age, gender, ethnicity, approximate height and weight, and a few questions about their dietary habits.
After the tablet dissolves, research assistants will ask the students to rate their craving for another piece of candy. Research assistants will ask participants if they would like another piece of candy and have them assess palatability again. The process of offering a piece of candy and asking subjects to rate palatability will occur up to five times. Finally, subjects will be asked if they would like to take a few pieces of candy for the road and if they say yes, the number of pieces they take with them will be noted. The study activities should last no more than 5-10 minutes per participant.
- Conditions
- Obesity
- Being tested
- Crave Crush, Placebo Comparator: Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crave CrushDietary supplement
Crave Crush is a dietary supplement that affects sweet taste receptors on the tongue.
Placebo Comparator: PlaceboDietary supplement
The placebo tablet is comparable in taste and is comprised primarily of sorbitol.
| Study group | Role | What they receive |
|---|---|---|
| Crave Crush | Experimental | Crave Crush is a plant-based tablet that alters taste perception by affecting sweet taste receptors on the tongue. Receives: Dietary Supplement: Crave Crush |
| Placebo | Placebo comparator | The placebo tablet is comparable in taste and is comprised primarily of sorbitol. Receives: Dietary Supplement: Placebo Comparator: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported Craving Reduction
Measured: 10 minutes
Secondary outcomes (1)
Self-Reported Palatability Reduction
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cravecrush, Oregon Behavioral Intervention Strategies, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744885
- Sponsor's protocol ID
- FOUR001
- Status last verified
- Jul 2018
- First submitted
- 18 Apr 2016
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Stice E, Yokum S, Gau JM. Gymnemic acids lozenge reduces short-term consumption of high-sugar food: A placebo controlled experiment. J Psychopharmacol. 2017 Nov;31(11):1496-1502. doi: 10.1177/0269881117728541. Epub 2017 Sep 25.
PubMed 28944714
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crave Crush: Sugar Cravings and ad Lib Candy Uptake
- ClinicalTrials.gov ID
- NCT02744885
- Acronym / sponsor ID
- FOUR001
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cravecrush, Oregon Behavioral Intervention Strategies, Inc.
- Study start
- Feb 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the research is to determine if participants who take "Crave Crush" will report lower cravings and palatability ratings of candy as compared to subjects who receive the placebo. Participants are self-selected university students who pass our table and verbally agree to participate in a research study about taste preferences. Data will be recorded anonymously.
Detailed description
When students approach the table, research assistants will ask them to choose their favorite kind of candy from an assortment. They will ask the subjects to rate their craving for the candy before they taste it. After they try the candy, the research assistants will ask them to rate its palatability. Then they will rate their craving for another piece of candy. A research assistant will flip a coin to determine whether the subject will receive Crave Crush or placebo. While the Crave Crush or placebo is dissolving in the mouth, the students will fill out a short questionnaire with an identification number. The questionnaire will ask for their age, gender, ethnicity, approximate height and weight, and a few questions about their dietary habits.
After the tablet dissolves, research assistants will ask the students to rate their craving for another piece of candy. Research assistants will ask participants if they would like another piece of candy and have them assess palatability again. The process of offering a piece of candy and asking subjects to rate palatability will occur up to five times. Finally, subjects will be asked if they would like to take a few pieces of candy for the road and if they say yes, the number of pieces they take with them will be noted. The study activities should last no more than 5-10 minutes per participant.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crave Crush | Experimental | Dietary Supplement: Crave CrushCrave Crush is a plant-based tablet that alters taste perception by affecting sweet taste receptors on the tongue. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo Comparator: PlaceboThe placebo tablet is comparable in taste and is comprised primarily of sorbitol. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- University student, having eaten within the last hour, having slept within two hours of their normal amount
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crave CrushCrave Crush is a dietary supplement that affects sweet taste receptors on the tongue. | Dietary supplement | Crave Crush |
| Placebo Comparator: PlaceboThe placebo tablet is comparable in taste and is comprised primarily of sorbitol. | Dietary supplement | Placebo |
Primary outcome
Self-Reported Craving Reduction
Time frame: 10 minutes
1 secondary outcome
Self-Reported Palatability Reduction
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Derived from this study: PubMed 28944714Stice E, Yokum S, Gau JM. Gymnemic acids lozenge reduces short-term consumption of high-sugar food: A placebo controlled experiment. J Psychopharmacol. 2017 Nov;31(11):1496-1502. doi: 10.1177/0269881117728541. Epub 2017 Sep 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Crave Crush in people with Obesity, run by Oregon Research Behavioral Intervention Strategies, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported Craving Reduction (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02744885, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018; AzTrials last refreshed its copy on 28 Oct 2026.