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

NCT ID: NCT00812162

Last Updated: 2013-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2011-07-31

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).

Conditions

Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

High protein diet.

Group Type: EXPERIMENTAL

Energy Restriction

Intervention Type: OTHER

Energy restricted diet of 750 kcal less than subjects requirement with a high protein diet.

2

Lower protein diet.

Group Type: EXPERIMENTAL

Energy Restriction

Intervention Type: OTHER

Energy restricted diet of 750 kcal less than subjects requirement with a lower protein diet.

Interventions

Energy Restriction

Energy restricted diet of 750 kcal less than subjects requirement with a high protein diet.

Intervention Type: OTHER

Energy Restriction

Energy restricted diet of 750 kcal less than subjects requirement with a lower protein diet.

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Purdue University

OTHER

Sponsor Role: lead

Responsible Party

Wayne Campbell

Wayne Campbell, Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wayne W Campbell, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

Purdue University

West Lafayette, Indiana, United States

Countries

United States

Other Identifiers

Pork Board 1320067860

Identifier Type: OTHER

Identifier Source: secondary_id

Egg Board 1320067903

Identifier Type: OTHER

Identifier Source: secondary_id

0610004602

Identifier Type: -

Identifier Source: org_study_id