ObesityNCT01490034
Effects of Learning and Food Form on Intake in Humans
A study testing Metabolic effects of consuming energy dense beverages, energy dense solid food and Energy dilute beverages in people with Obesity, run by Purdue University at 1 site in United States.
Trial summary
Due to the rising incidence of obesity, much emphasis has been placed on identifying mechanisms of increased energy intake. At this point, the mechanisms responsible for the recent increase in obesity prevalence have not been thoroughly examined. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Metabolic effects of consuming energy dense beverages, energy dense solid food and Energy dilute beverages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Weight stable (<3 kg weight change within last 3 months)
- Constant habitual activity patterns (no deviation > 1x/wk at 30 min/session within last 3 months)
- Constant habitual diet patterns within last 3 months
- Willingness to eat a chocolate-flavored snack at test sessions and two week training period
- No allergies to any test foods
- Not planning to change use of medications known to influence appetite or metabolism
Show all 9Show fewer
- Not diabetic
- No history of GI pathology
- Non-smoker for one year or more
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Due to the rising incidence of obesity, much emphasis has been placed on identifying mechanisms of increased energy intake. At this point, the mechanisms responsible for the recent increase in obesity prevalence have not been thoroughly examined. Pre-ingestive influences, such as cognitive factors, may play a larger role in creating an energy surplus than previously thought. Expectations about the satiating effect of a food may override the post-ingestive influences in dictating further consumption. In addition, obese individuals may exhibit a decreased compensatory response to foods as compared to lean individuals.
Understanding the effects of energy content, food form, and learning on satiation, satiety, and energy intake will allow for a greater understanding of the mechanisms of energy imbalance as a whole. Food choice is dictated by sensory properties and post-ingestive effects. By utilizing foods with similar sensory properties, the acquired knowledge derived from ingesting these foods can be monitored by analyzing subsequent intake at the same meal and at subsequent eating occurrences. It is hypothesized that the liquid food form will elicit weaker dietary compensation; that is, energy intake at other eating events will not be adjusted to compensate for that food. In addition, it is posited that the lower energy food will cause lower compensation postprandially. By having participants consume the same test food daily over a two week learning period, it is thought that they will show improved dietary compensation when the initial testing is repeated due to learned associations between food properties and metabolism.
Read the detailed description
No expansion provided.
- Conditions
- Obesity
- Being tested
- Metabolic effects of consuming energy dense beverages, energy dense solid food, Energy dilute beverages, Energy dilute solid food
- Keywords
- obesity, energy intake, appetite, food form, beverage, learning, dietary compensation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic effects of consuming energy dense beveragesBehavioural
Consumption of energy dense beverages for 2 weeks and monitoring physiological responses
energy dense solid foodBehavioural
Effects of consuming energy dense solid food for two weeks on physiological responses
Energy dilute beveragesBehavioural
Effects of consuming energy dilute beverages for two weeks on physiological responses.
Energy dilute solid foodBehavioural
Effects of consuming energy dilute solid food for two weeks on physiological responses
| Study group | Role | What they receive |
|---|---|---|
| Energy dense beverage | Experimental | Metabolic effects of consuming energy dense beverages before and after regular consumption Receives: Behavioral: Metabolic effects of consuming energy dense beverages |
| Energy dense solid food form | Experimental | Metabolic effects of consuming energy dense solid foods before and after regular exposure. Receives: Behavioral: energy dense solid food |
| Eenergy dilute beverages | Experimental | Metabolic effects of consumption of energy dilute beverages on a regular basis. Receives: Behavioral: Energy dilute beverages |
| Energy dilute solid food form | Experimental | Metabolic effects of consuming energy dilute sold foods before and after regular exposure. Receives: Behavioral: Energy dilute solid food |
What is being measured
The primary outcome is the main question the study is designed to answer.
energy intake
Energy consumed over 12 weeks of intervention.
Measured: 12 weeks
dietary compensation
spontaneous dietary adjustment in response to intervention
Measured: 12 weeks
appetite
Effects of intervention on appetitive sensation such as hunger and fullness
Measured: 12 weeks
effects of learning on energy intake
The effects of learning based on exposure to products that are high or low in energy and liquid or solid
Measured: 12 weeks
Effects of food form on energy intake
The effects of food form on energy intake before and after chronic exposure to foods varying in food form and energy density
Measured: 12 weeks
Effects of BMI on sensory learning
The effects of BMI on appetite, energy intake and dietary compensation
Measured: 12 weeks
Secondary outcomes (1)
Effects of personality traits on appetite, energy intake and compensation
Effects of personality traits related to feeding on appetite, energy intake and compensation following exposure to foods of different physical form, energy density and before and after learning.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2013
- Study completionMay 2015
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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Mattes, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490034
- Sponsor's protocol ID
- R01DK079913-3
- Other IDs
- R01DK079913
- Status last verified
- Oct 2015
- First submitted
- 5 Dec 2011
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Jones JB, Mattes RD. Effects of learning and food form on energy intake and appetitive responses. Physiol Behav. 2014 Oct;137:1-8. doi: 10.1016/j.physbeh.2014.06.016. Epub 2014 Jun 21.
PubMed 24955495
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Learning and Food Form on Intake in Humans
- ClinicalTrials.gov ID
- NCT01490034
- Acronym / sponsor ID
- R01DK079913-3
- Conditions
- Obesity
- Keywords
- obesity, energy intake, appetite, food form, beverage, learning, dietary compensation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 12 Dec 2011 (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.
Due to the rising incidence of obesity, much emphasis has been placed on identifying mechanisms of increased energy intake. At this point, the mechanisms responsible for the recent increase in obesity prevalence have not been thoroughly examined. Pre-ingestive influences, such as cognitive factors, may play a larger role in creating an energy surplus than previously thought. Expectations about the satiating effect of a food may override the post-ingestive influences in dictating further consumption. In addition, obese individuals may exhibit a decreased compensatory response to foods as compared to lean individuals.
Understanding the effects of energy content, food form, and learning on satiation, satiety, and energy intake will allow for a greater understanding of the mechanisms of energy imbalance as a whole. Food choice is dictated by sensory properties and post-ingestive effects. By utilizing foods with similar sensory properties, the acquired knowledge derived from ingesting these foods can be monitored by analyzing subsequent intake at the same meal and at subsequent eating occurrences. It is hypothesized that the liquid food form will elicit weaker dietary compensation; that is, energy intake at other eating events will not be adjusted to compensate for that food. In addition, it is posited that the lower energy food will cause lower compensation postprandially. By having participants consume the same test food daily over a two week learning period, it is thought that they will show improved dietary compensation when the initial testing is repeated due to learned associations between food properties and metabolism.
Detailed description
No expansion provided.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Energy dense beverage | Experimental | Behavioral: Metabolic effects of consuming energy dense beveragesMetabolic effects of consuming energy dense beverages before and after regular consumption |
| Energy dense solid food form | Experimental | Behavioral: energy dense solid foodMetabolic effects of consuming energy dense solid foods before and after regular exposure. |
| Eenergy dilute beverages | Experimental | Behavioral: Energy dilute beveragesMetabolic effects of consumption of energy dilute beverages on a regular basis. |
| Energy dilute solid food form | Experimental | Behavioral: Energy dilute solid foodMetabolic effects of consuming energy dilute sold foods before and after regular exposure. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Weight stable (<3 kg weight change within last 3 months)
- Constant habitual activity patterns (no deviation > 1x/wk at 30 min/session within last 3 months)
- Constant habitual diet patterns within last 3 months
- Willingness to eat a chocolate-flavored snack at test sessions and two week training period
- No allergies to any test foods
Key exclusion criteria (0 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 |
|---|---|---|
| Metabolic effects of consuming energy dense beveragesConsumption of energy dense beverages for 2 weeks and monitoring physiological responses | Behavioural | Energy dense beverage |
| energy dense solid foodEffects of consuming energy dense solid food for two weeks on physiological responses | Behavioural | Energy dense solid food form |
| Energy dilute beveragesEffects of consuming energy dilute beverages for two weeks on physiological responses. | Behavioural | Eenergy dilute beverages |
| Energy dilute solid foodEffects of consuming energy dilute solid food for two weeks on physiological responses | Behavioural | Energy dilute solid food form |
Primary outcome
energy intake
Time frame: 12 weeks
Energy consumed over 12 weeks of intervention.
dietary compensation
Time frame: 12 weeks
spontaneous dietary adjustment in response to intervention
appetite
Time frame: 12 weeks
Effects of intervention on appetitive sensation such as hunger and fullness
effects of learning on energy intake
Time frame: 12 weeks
The effects of learning based on exposure to products that are high or low in energy and liquid or solid
Effects of food form on energy intake
Time frame: 12 weeks
The effects of food form on energy intake before and after chronic exposure to foods varying in food form and energy density
Effects of BMI on sensory learning
Time frame: 12 weeks
The effects of BMI on appetite, energy intake and dietary compensation
1 secondary outcome
Effects of personality traits on appetite, energy intake and compensation
Time frame: 12 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 Oct 2015.
- Derived from this study: PubMed 24955495Jones JB, Mattes RD. Effects of learning and food form on energy intake and appetitive responses. Physiol Behav. 2014 Oct;137:1-8. doi: 10.1016/j.physbeh.2014.06.016. Epub 2014 Jun 21.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metabolic effects of consuming energy dense beverages, energy dense solid food and Energy dilute beverages in people with Obesity, 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 0 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 Oct 2015. 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?
energy intake (time frame: 12 weeks). The study lists 6 primary outcomes in all. 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 NCT01490034, 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 15 Oct 2015.