Pre- and Post-restriction Chocolate Candy Consumption

December 11, 2023 updated by: Richard Mattes, Purdue University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • West Lafayette, Indiana, United States, 47906
        • Purdue University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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
  • 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

Exclusion Criteria:

  • If a participant does not fit the above requirements, they will be excluded from participating in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Chocolate pre-restriction
Other: Snack Condition Specification
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 Names:
  • Generic Branded Snack Foods (commerically available)
Other: Chocolate Baseline
Other: Snack Condition Specification
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 Names:
  • Generic Branded Snack Foods (commerically available)
Other: Chocolate post-restriction
Other: Snack Condition Specification
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 Names:
  • Generic Branded Snack Foods (commerically available)
Other: Salty Snacks
Other: Snack Condition Specification
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 Names:
  • Generic Branded Snack Foods (commerically available)
Other: Sweet Non-Chocolate Snacks
Other: Snack Condition Specification
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 Names:
  • Generic Branded Snack Foods (commerically available)
Other: Dried Fruit
Other: Snack Condition Specification
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 Names:
  • Generic Branded Snack Foods (commerically available)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
over one week at baseline and another week after chocolate restriction

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Snack and Craving Preference
Time Frame: 6 weeks
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Purdue University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard D Mattes, PhD, Purdue University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2013

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 055-037
  • 0911008653 (Registry Identifier: Purdue University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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