Effects of Dietary Pork and Egg on Appetite, Meal-Patterning, and Weight Loss in Men - Full Text View

Sponsored by:	Purdue University
Information provided by:	Purdue University
ClinicalTrials.gov Identifier:	NCT00812162

Purpose

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).

Condition	Intervention
Weight Loss	Other: Energy Restriction

MedlinePlus related topics: Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment

Further study details as provided by Purdue University:

Primary Outcome Measures:

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. [ Time Frame: 12 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. [ Time Frame: 12 week ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	72
Study Start Date:	January 2007
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental High protein diet.	Other: Energy Restriction Energy restricted diet of 750 kcal less than subjects requirement with a high protein diet.
2: Experimental Lower protein diet.	Other: Energy Restriction Energy restricted diet of 750 kcal less than subjects requirement with a lower protein diet.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812162

Locations

United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907

Sponsors and Collaborators

Purdue University

More Information

Responsible Party:	Purdue University ( Wayne Campbell )
Study ID Numbers:	0610004602, Pork Board 1320067860, Egg Board 1320067903
Study First Received:	December 18, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00812162
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Weight Loss
Body Weight Changes

ClinicalTrials.gov processed this record on January 13, 2009