- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01490034
Effects of Learning and Food Form on Intake in Humans
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
-
W. Lafayette, Indiana, United States, 47907
- Purdue Univeristy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- Not diabetic
- No history of GI pathology
- Non-smoker for one year or more
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Energy dense beverage
Metabolic effects of consuming energy dense beverages before and after regular consumption
|
Consumption of energy dense beverages for 2 weeks and monitoring physiological responses
|
|
Experimental: Energy dense solid food form
Metabolic effects of consuming energy dense solid foods before and after regular exposure.
|
Effects of consuming energy dense solid food for two weeks on physiological responses
|
|
Experimental: Eenergy dilute beverages
Metabolic effects of consumption of energy dilute beverages on a regular basis.
|
Effects of consuming energy dilute beverages for two weeks on physiological responses.
|
|
Experimental: Energy dilute solid food form
Metabolic effects of consuming energy dilute sold foods before and after regular exposure.
|
Effects of consuming energy dilute solid food for two weeks on physiological responses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
energy intake
Time Frame: 12 weeks
|
Energy consumed over 12 weeks of intervention.
|
12 weeks
|
|
dietary compensation
Time Frame: 12 weeks
|
spontaneous dietary adjustment in response to intervention
|
12 weeks
|
|
appetite
Time Frame: 12 weeks
|
Effects of intervention on appetitive sensation such as hunger and fullness
|
12 weeks
|
|
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
|
12 weeks
|
|
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
|
12 weeks
|
|
Effects of BMI on sensory learning
Time Frame: 12 weeks
|
The effects of BMI on appetite, energy intake and dietary compensation
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effects of personality traits on appetite, energy intake and compensation
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DK079913-3
- R01DK079913 (U.S. NIH Grant/Contract)
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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