Combined Effects of Energy Density and Eating Rate on App... | NCT01406886

Studies
Combined Effects of Energy Density and Eating Rate on Appetite

NCT01406886

Sponsor

United States Army Research Institute of Environmental Medicine

Status

Completed

Last Update Posted

Oct 17, 2017Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Appetite

Interventions

Eating rate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Jul 5, 2011

First Submission Date that Met QC Criteria

Jul 29, 2011

First Posted Date

Aug 1, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2017

Last Update Posted Date

Oct 17, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

James Philip Karl, Research Dietitian, United States Army Research Institute of Environmental MedicinePrincipal Investigator

Lead Sponsor

United States Army Research Institute of Environmental MedicineFED

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will examine the independent and combined effects of energy density and eating rate on appetite and endocrine mediators of appetite. Increasing eating rate and energy intake are expected to additively increase energy intake.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Energy density	Experimental	Low or high energy density meal	Behavioral: Eating rate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Eating rate	Behavioral		Energy density

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Energy intake		1 meal

Secondary Outcomes

Measure	Description	Time Frame
Subjective appetite		0-180 min
Postprandial peptide-YY response		0-180 min
Postprandial ghrelin response

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI 18-27 kg/m2
Weight stable

Exclusion criteria:

Chronic used of OTC or prescription drugs known to affect metabolism
Chronic disease
Gastric bypass surgery
Disordered eating
Pregnant or breastfeeding

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Scott J Montain, PhD	US Army Research Institute of Environmental Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
USARIEM		Natick	Massachusetts	01760	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23592679	Result	Karl JP, Young AJ, Rood JC, Montain SJ. Independent and combined effects of eating rate and energy density on energy intake, appetite, and gut hormones. Obesity (Silver Spring). 2013 Mar;21(3):E244-52. doi: 10.1002/oby.20075.