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

NCT00812162 | Completed DMC

• 3 other identifiers: 0610004602Pork Board 1320067860Egg Board 1320067903
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

High protein diet.

Other: Energy Restriction

2

EXPERIMENTAL

Lower protein diet.

Other: Energy Restriction

Interventions

Energy Restriction OTHER

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

1

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Purdue University: lead

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wayne W Campbell, Ph.D.

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Wayne Campbell, Ph.D.

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 22, 2008
• Study Start: January 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: July 1, 2011
• Last Updated: January 17, 2013

Record last verified: 2013-01

Locations

US (1)