Investigate the Maladaptive Eating Behaviors of Normal Healthy AdultsNCT02003950
Pre- and Post-restriction Chocolate Candy Consumption
A study testing Snack Condition Specification in people with Investigate the Maladaptive Eating Behaviors of Normal Healthy Adults, run by Purdue University at 1 site in United States.
Trial summary
Craving differs from hunger because it occurs even when a person is in a satiated state and in the absence of an energy deficit. Craving is usually triggered by specific foods and may be attributable to certain sensory properties of foods. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Investigate the Maladaptive Eating Behaviors of Normal Healthy Adults
- What is being tested?
- Snack Condition Specification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to May 2015
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sixty adult participants (age 18-60 years) who are regular chocolate candy eaters (> 4 times/week, at least 1 serving each time) are needed to complete this study. Additional eligible criteria include:
- Subjects high and low in restraint/disinhibition based on TFEQ
- BMI between 18-35
- American born, or have lived in United States for majority of life, as different cultures have been shown to have lower chocolate preferences and consumption.
- Snack on a regular basis
- No allergies to test foods
Show all 9Show fewer
- Not taking medications that affect appetite or metabolism
- Willing to comply to study protocol and to eat test meals
- Consume chocolate, or chocolate candies more than 4 times per week
Who cannot join
- If a participant does not fit the above requirements, they will be excluded from participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Three-Week Chocolate Candy Restriction on Pre- and Post-restriction Chocolate Candy Consumption in Healthy Adults
Craving differs from hunger because it occurs even when a person is in a satiated state and in the absence of an energy deficit. Craving is usually triggered by specific foods and may be attributable to certain sensory properties of foods. Foods that are craved are often regarded as less healthy choices, and are higher in energy content. Chocolate is one of the most commonly reported foods craved by people in this country. Together, craving for chocolate has been suggested to be a possible cause of weight gain and access to chocolate therefore needs to be restricted.
However, it remains unknown if restriction may induce maladaptive eating behaviors of chocolate cravers. The anticipation of going on a diet has been shown to cause restrained and disinhibited eaters to react by consuming more chocolate. In this study, we will examine if this response is also found in chocolate cravers when they are asked to undergo three weeks of chocolate restriction. This study will also examine chocolate cravers' response after the chocolate restriction is lifted. We hypothesize that chocolate consumption of cravers will increase both before and after chocolate restriction is imposed. We also hypothesize that chocolate craving is specific to the food rather than its sweet taste, and that chocolate cravers are less willing to substitute chocolate for salty snacks, natural snacks, and sweet non-chocolate snacks during the restriction.
- Being tested
- Snack Condition Specification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Snack Condition SpecificationOther
Also called Generic Branded Snack Foods (commerically available)
Individuals recieve a different snack for every week of the study. This is viewed as 4 phases. Phase 1 measures of habitual chocolate candy consumption (1 week), Phase 2 assesses participants' chocolate consumption while anticipating an oncoming chocolate candy restriction (1 week), Phase 3 is the total chocolate candy restriction period, but participants will be given 3 non-chocolate-candy snack substitutes in a random order (1 week per snack type, 3 weeks total), and Phase 4 examines participants' chocolate candy consumption when the 3-week restriction is lifted (1 week).
| Study group | Role | What they receive |
|---|---|---|
| Chocolate pre-restriction | Other | Not described Receives: Other: Snack Condition Specification |
| Chocolate Baseline | Other | Not described Receives: Other: Snack Condition Specification |
| Chocolate post-restriction | Other | Not described Receives: Other: Snack Condition Specification |
| Salty Snacks | Other | Not described Receives: Other: Snack Condition Specification |
| Sweet Non-Chocolate Snacks | Other | Not described Receives: Other: Snack Condition Specification |
| Dried Fruit | Other | Not described Receives: Other: Snack Condition Specification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intake in kcal
The primary objective of this study is to investigate the anticipatory- (before) and reactive-responses (after) of regular chocolate candy consumers to a three-week total chocolate candy restriction.
Measured: over one week at baseline and another week after chocolate restriction
Secondary outcomes (1)
Snack and Craving Preference
A secondary objective of this study is to examine if the observed responses before and after chocolate candy restriction can be predicted by participants' personality, ingestive behavior and food craving status. Providing different snacks to the participants during the restriction period will allow us to determine if craving is specific to specific foods, in the case of this study, chocolate. Cravings will be measured three times per week for six weeks.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Investigate the Maladaptive Eating Behaviors of Normal Healthy AdultsStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Mattes, Purdue University
- Investigators
- Richard D Mattes, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003950
- Sponsor's protocol ID
- 055-037
- Other IDs
- 0911008653
- Status last verified
- Dec 2023
- First submitted
- 15 Nov 2013
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Three-Week Chocolate Candy Restriction on Pre- and Post-restriction Chocolate Candy Consumption in Healthy Adults
- ClinicalTrials.gov ID
- NCT02003950
- Acronym / sponsor ID
- 055-037
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 6 Dec 2013 (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.
Craving differs from hunger because it occurs even when a person is in a satiated state and in the absence of an energy deficit. Craving is usually triggered by specific foods and may be attributable to certain sensory properties of foods. Foods that are craved are often regarded as less healthy choices, and are higher in energy content. Chocolate is one of the most commonly reported foods craved by people in this country. Together, craving for chocolate has been suggested to be a possible cause of weight gain and access to chocolate therefore needs to be restricted.
However, it remains unknown if restriction may induce maladaptive eating behaviors of chocolate cravers. The anticipation of going on a diet has been shown to cause restrained and disinhibited eaters to react by consuming more chocolate. In this study, we will examine if this response is also found in chocolate cravers when they are asked to undergo three weeks of chocolate restriction. This study will also examine chocolate cravers' response after the chocolate restriction is lifted. We hypothesize that chocolate consumption of cravers will increase both before and after chocolate restriction is imposed. We also hypothesize that chocolate craving is specific to the food rather than its sweet taste, and that chocolate cravers are less willing to substitute chocolate for salty snacks, natural snacks, and sweet non-chocolate snacks during the restriction.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Chocolate pre-restriction | Other | Other: Snack Condition Specification |
| Chocolate Baseline | Other | Other: Snack Condition Specification |
| Chocolate post-restriction | Other | Other: Snack Condition Specification |
| Salty Snacks | Other | Other: Snack Condition Specification |
| Sweet Non-Chocolate Snacks | Other | Other: Snack Condition Specification |
| Dried Fruit | Other | Other: Snack Condition Specification |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Sixty adult participants (age 18-60 years) who are regular chocolate candy eaters (> 4 times/week, at least 1 serving each time) are needed to complete this study. Additional eligible criteria include:
- Subjects high and low in restraint/disinhibition based on TFEQ
- BMI between 18-35
- American born, or have lived in United States for majority of life, as different cultures have been shown to have lower chocolate preferences and consumption.
- Snack on a regular basis
Key exclusion criteria (1 listed)
- If a participant does not fit the above requirements, they will be excluded from participating in the study.
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 |
|---|---|---|
| Snack Condition SpecificationAlso: Generic Branded Snack Foods (commerically available)Individuals recieve a different snack for every week of the study. This is viewed as 4 phases. Phase 1 measures of habitual chocolate candy consumption (1 week), Phase 2 assesses participants' chocolate consumption while anticipating an oncoming chocolate candy restriction (1 week), Phase 3 is the total chocolate candy restriction period, but participants will be given 3 non-chocolate-candy snack substitutes in a random order (1 week per snack type, 3 weeks total), and Phase 4 examines participants' chocolate candy consumption when the 3-week restriction is lifted (1 week). | Other | Chocolate Baseline, Chocolate post-restriction, Chocolate pre-restriction, Dried Fruit, Salty Snacks, Sweet Non-Chocolate Snacks |
Primary outcome
Intake in kcal
Time frame: over one week at baseline and another week after chocolate restriction
The primary objective of this study is to investigate the anticipatory- (before) and reactive-responses (after) of regular chocolate candy consumers to a three-week total chocolate candy restriction.
1 secondary outcome
Snack and Craving Preference
Time frame: 6 weeks
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 15 Dec 2023.
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.
Richard D Mattes, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Snack Condition Specification in people with Investigate the Maladaptive Eating Behaviors of Normal Healthy Adults, run by Purdue University at 1 site in United States.
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 9 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 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Intake in kcal (time frame: over one week at baseline and another week after chocolate restriction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2023.