NCT01406886

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2009

Shorter than P25 for not_applicable

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

December 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2011

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
Last Updated

October 17, 2017

Status Verified

October 1, 2017

Enrollment Period

6 months

First QC Date

July 5, 2011

Last Update Submit

October 15, 2017

Conditions

Appetite

Keywords

Modifiable environmentalbehavioral factors

Outcome Measures

Primary Outcomes (1)

  • Energy intake

    1 meal

Secondary Outcomes (5)

  • Subjective appetite

    0-180 min

  • Postprandial peptide-YY response

    0-180 min

  • Postprandial ghrelin response

    0-180 min

  • Postprandial glucagon-like peptide-1 response

    0-180 min

  • Postprandial pancreatic polypeptide response

    0-180 min

Study Arms (1)

Energy density

EXPERIMENTAL

Low or high energy density meal

Behavioral: Eating rate

Interventions

Eating rateBEHAVIORAL
Energy density

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 18-27 kg/m2
  • Weight stable

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USARIEM

Natick, Massachusetts, 01760, United States

Location

Related Publications (1)

  • 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.

    PMID: 23592679RESULT

Study Officials

  • Scott J Montain, PhD

    US Army Research Institute of Environmental Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Dietitian

Study Record Dates

First Submitted

July 5, 2011

First Posted

August 1, 2011

Study Start

December 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

October 17, 2017

Record last verified: 2017-10

Locations

US(1)