Reinforcing Value of FoodNCT03981172
Food Reinforcement, Weight Status, and Energy Density
An observational study of Reinforcing Value of Food, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The investigators previous studies have shown that obese and non-obese individuals respond differently to daily intake of snack food. The purpose of this study was to determine whether these differences are specific to high energy density snack foods. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reinforcing Value of Food
- What is being tested?
- Daily snack food intake
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Aug 2009
- Phase
- Observational
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women ages 18 - 50 were recruited.
Who may be able to join
- 18 - 50 years old, female, like study foods.
Who cannot join
- current smoker, currently on a diet, medical conditions or medication affecting appetite (ex. methylphenidate).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Daily Snack Food Intake on Food Reinforcement Depend on Weight Status and Energy Density
The investigators previous studies have shown that obese and non-obese individuals respond differently to daily intake of snack food. The purpose of this study was to determine whether these differences are specific to high energy density snack foods. The investigators hypothesized that obese individuals would show an increase in motivation to obtain high energy density snack foods after two weeks of daily consumption, but that non-obese women and obese women consuming low energy density foods would have reduced motivation to consume snack foods after two weeks of daily consumption.
- Conditions
- Reinforcing Value of Food
- Being tested
- Daily snack food intake
- Keywords
- food reinforcement, food liking, motivation, dopamine, obesity, energy density, snacks
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily snack food intakeBehavioural
participants consumed 60 gram portions of either low energy density or high energy density snack foods every day for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Non-obese/HED | Non-obese women given 60 gram portions of high energy density snack foods to consume daily for two weeks. Receives: Behavioral: Daily snack food intake | |
| Non-Obese/LED | Non-obese participants that were given 60 gram portions of low energy density foods to consume daily for two weeks. Receives: Behavioral: Daily snack food intake | |
| Obese/LED | Obese participants that were given 60 gram portions of low energy density snack foods to consume daily for two weeks. Receives: Behavioral: Daily snack food intake | |
| Obese/HED | Obese participants that were given 60 gram portions of high energy density snack foods to consume daily for two weeks. Receives: Behavioral: Daily snack food intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of operant responses
Participants were asked to click a mouse button to gain access to food. A point was earned after a certain number of button presses and after 5 points were earned, the participant received 100 kcal portion of food.
Measured: about one month
Secondary outcomes (1)
Food liking
participants rated how much they liked the food on a Likert-type scale.
Measured: about one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study startSep 2008
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reinforcing Value of FoodStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Temple, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981172
- Sponsor's protocol ID
- Temple10132009
- Status last verified
- Jun 2019
- First submitted
- 24 Mar 2011
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Daily Snack Food Intake on Food Reinforcement Depend on Weight Status and Energy Density
- ClinicalTrials.gov ID
- NCT03981172
- Acronym / sponsor ID
- Temple10132009
- Conditions
- Reinforcing Value of Food
- Keywords
- food reinforcement, food liking, motivation, dopamine, obesity, energy density, snacks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 10 Jun 2019 (actual)
- 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 investigators previous studies have shown that obese and non-obese individuals respond differently to daily intake of snack food. The purpose of this study was to determine whether these differences are specific to high energy density snack foods. The investigators hypothesized that obese individuals would show an increase in motivation to obtain high energy density snack foods after two weeks of daily consumption, but that non-obese women and obese women consuming low energy density foods would have reduced motivation to consume snack foods after two weeks of daily consumption.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-obese/HED | – | Behavioral: Daily snack food intakeNon-obese women given 60 gram portions of high energy density snack foods to consume daily for two weeks. |
| Non-Obese/LED | – | Behavioral: Daily snack food intakeNon-obese participants that were given 60 gram portions of low energy density foods to consume daily for two weeks. |
| Obese/LED | – | Behavioral: Daily snack food intakeObese participants that were given 60 gram portions of low energy density snack foods to consume daily for two weeks. |
| Obese/HED | – | Behavioral: Daily snack food intakeObese participants that were given 60 gram portions of high energy density snack foods to consume daily for two weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women ages 18 - 50 were recruited.
Key inclusion criteria (1 listed)
- 18 - 50 years old, female, like study foods.
Key exclusion criteria (1 listed)
- current smoker, currently on a diet, medical conditions or medication affecting appetite (ex. methylphenidate).
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 |
|---|---|---|
| Daily snack food intakeparticipants consumed 60 gram portions of either low energy density or high energy density snack foods every day for two weeks. | Behavioural | Non-Obese/LED, Non-obese/HED, Obese/HED, Obese/LED |
Primary outcome
Number of operant responses
Time frame: about one month
Participants were asked to click a mouse button to gain access to food. A point was earned after a certain number of button presses and after 5 points were earned, the participant received 100 kcal portion of food.
1 secondary outcome
Food liking
Time frame: about one month
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 10 Jun 2019.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reinforcing Value of Food, run by State University of New York at Buffalo 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 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 10 Jun 2019. 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?
Number of operant responses (time frame: about one month). 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 10 Jun 2019.