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

Primary Purpose

Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Energy Restriction
Energy Restriction
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weight Loss

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Purdue University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

High protein diet.

Lower protein diet.

Outcomes

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.

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.

Full Information

First Posted
December 18, 2008
Last Updated
January 16, 2013
Sponsor
Purdue University
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1. Study Identification

Unique Protocol Identification Number
NCT00812162
Brief Title
Effects of Dietary Pork and Egg on Appetite, Meal-patterning, and Weight Loss in Men
Official Title
Effects of Dietary Pork and Egg on Appetite, Meal-patterning, and Weight Loss in Men
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
High protein diet.
Arm Title
2
Arm Type
Experimental
Arm Description
Lower protein diet.
Intervention Type
Other
Intervention Name(s)
Energy Restriction
Intervention Description
Energy restricted diet of 750 kcal less than subjects requirement with a high protein diet.
Intervention Type
Other
Intervention Name(s)
Energy Restriction
Intervention Description
Energy restricted diet of 750 kcal less than subjects requirement with a lower protein diet.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne W Campbell, Ph.D.
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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