The Effect of Changing the Eating Speed on Energy Intake | NCT01684553

Studies
The Effect of Changing the Eating Speed on Energy Intake

NCT01684553

Sponsor

Texas Christian University

Status

Completed

Last Update Posted

Sep 13, 2012Estimated

Enrollment

70Actual

Phase

Not Applicable

Conditions

Oral Intake Reduced

Interventions

Slow eating condition
Fast eating condition

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

Sep 2012

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

Feb 2011

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Sep 5, 2012

First Submission Date that Met QC Criteria

Sep 12, 2012

First Posted Date

Sep 13, 2012Estimated

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

Sep 12, 2012

Last Update Posted Date

Sep 13, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

It was hypothesized that eating a meal slowly would lead to a lower meal energy intake and lesser feelings of hunger and desire to eat and higher levels of fullness after the meal compared to eating the same meal more quickly.

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

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Slow eating condition	Experimental	The subjects were asked to eat their meal slowly during the slow eating condition	Behavioral: Slow eating condition
Fast eating condition	Active Comparator	The subjects were asked to eat their meal quickly during the fast eating condition	Behavioral: Fast eating condition

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Slow eating condition	Behavioral	The subjects were asked to eat their meal slowly during the slow eating condition	Slow eating condition

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Meal energy intake		Day 1
Meal energy intake		Day 2

Secondary Outcomes

Measure	Description	Time Frame
Hunger questionnaire		0 and 60 min after the meal began
Fullness questionnaire		0 and 60 min after the meal began
Desire to eat questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women ages 19-65 years.

Exclusion Criteria:

Severe obesity (BMI ≥ 40 kg/m2),
dieting,
taking medications that affect appetite,
participating in > 150 min/wk of vigorous physical activity,
smoking,
drinking heavily (men: > 14 alcoholic drinks/wk; women: > 7 alcoholic drinks/wk),
self-reported disordered eating,
depression,
type 1 or 2 diabetes,
adrenal disease, or
untreated thyroid disease.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Meena Shah, Ph.D.	Tzu Chi University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Texas Christian University		Fort Worth	Texas	76129	United States