Effects of Dietary Pork and Egg on Appetite, Meal-pattern... | NCT00812162

Studies
Effects of Dietary Pork and Egg on Appetite, Meal-patterning, and Weight Loss in Men

NCT00812162

Sponsor

Purdue University

Status

Completed

Last Update Posted

Jan 17, 2013Estimated

Enrollment

48Actual

Phase

Not Applicable

Conditions

Weight Loss

Interventions

Energy Restriction
Energy Restriction

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

ID	Type	Description	Link
Pork Board 1320067860	Other Identifier	National Pork Board
Egg Board 1320067903	Other Identifier	American Egg Board

Status Module

Record Verification Date

Jan 2013

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

Jan 2007

Primary Completion Date

Feb 2009Actual

Completion Date

Jul 2011Actual

First Submitted Date

Dec 18, 2008

First Submission Date that Met QC Criteria

Dec 18, 2008

First Posted Date

Dec 22, 2008Estimated

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

Jan 16, 2013

Last Update Posted Date

Jan 17, 2013Estimated

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

The purpose of this study is to identify how adult men respond to a weight loss diet that includes pork and eggs and increasing the number of meals consumed throughout the day. This is a 13-week study (12-weeks of weight loss and 1-week of baseline measurement).

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

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	High protein diet.	Other: Energy Restriction
2	Experimental	Lower protein diet.	Other: Energy Restriction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Energy Restriction	Other	Energy restricted diet of 750 kcal less than subjects requirement with a high protein diet.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary aim is to examine the effects of increased protein intake on appetite, selected appetite hormones (insulin, leptin, ghrelin), whole body energy expenditure, and body composition (fat mass and fat-free mass) changes.		12 week

Secondary Outcomes

Measure	Description	Time Frame
The secondary aim of this study is to evaluate the effects of meal frequency on appetite by asking the men to frequently rate their appetite on days that they purposefully eat 3 vs. 6 times/day.		12 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age range: 21 years and older
Body mass index between 25.0-39.9 kg/m2
Weight stable (< 4.5 kg (~10 lbs) weight gain or loss within last 6 months)
Body fat >25% (assessed by skinfold and plethysmography (if needed))
Non-smoking (within the last 6 months)
Constant habitual activity patterns (within last 3 months)
Clinically normal blood profiles (specifically, normal liver and kidney function; fasting blood glucose <110 mg/dl)
Not taking medications known to influence appetite or metabolism
Non-diabetic

Exclusion Criteria:

Age: <21 years
Body mass index: outside of the 25.0-39.9 kg/m2 range
Gained or lost > 4.5 kg (10 lbs) within the last 6 months
Body fat <25% as assessed by plethysmography
Smoker (currently or within the last 6 months)
Intermittently been involved in a diet and/or exercise program within the last 3 months
Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD
Taking medications (currently or within the last 3 months) known to influence appetite or metabolism
Clinically diagnosed as diabetic
Allergies to eggs
Lactose intolerance
Clinically diagnosed with diverticulosis
Clinically diagnosed with diverticulitis

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms