NCT01490034

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 12, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

October 15, 2015

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

December 5, 2011

Last Update Submit

October 14, 2015

Conditions

Keywords

obesityenergy intakeappetitefood formbeveragelearningdietary compensation

Outcome Measures

Primary Outcomes (6)

  • energy intake

    Energy consumed over 12 weeks of intervention.

    12 weeks

  • dietary compensation

    spontaneous dietary adjustment in response to intervention

    12 weeks

  • appetite

    Effects of intervention on appetitive sensation such as hunger and fullness

    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

    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

    12 weeks

  • Effects of BMI on sensory learning

    The effects of BMI on appetite, energy intake and dietary compensation

    12 weeks

Secondary Outcomes (1)

  • Effects of personality traits on appetite, energy intake and compensation

    12 weeks

Study Arms (4)

Energy dense beverage

EXPERIMENTAL

Metabolic effects of consuming energy dense beverages before and after regular consumption

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.

Behavioral: energy dense solid food

Eenergy dilute beverages

EXPERIMENTAL

Metabolic effects of consumption of energy dilute beverages on a regular basis.

Behavioral: Energy dilute beverages

Energy dilute solid food form

EXPERIMENTAL

Metabolic effects of consuming energy dilute sold foods before and after regular exposure.

Behavioral: Energy dilute solid food

Interventions

Consumption of energy dense beverages for 2 weeks and monitoring physiological responses

Energy dense beverage

Effects of consuming energy dense solid food for two weeks on physiological responses

Energy dense solid food form

Effects of consuming energy dilute beverages for two weeks on physiological responses.

Eenergy dilute beverages

Effects of consuming energy dilute solid food for two weeks on physiological responses

Energy dilute solid food form

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue Univeristy

West Lafayette, Indiana, 47907, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 12, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2013

Study Completion

May 1, 2015

Last Updated

October 15, 2015

Record last verified: 2015-10

Locations