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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812162
• Other study ID #: 0610004602
• Secondary ID: Pork Board 13200
• Status: Completed
• Phase: N/A
• First received: December 18, 2008
• Last updated: January 16, 2013
• Start date: January 2007
• Est. completion date: July 2011

Study information

• Verified date: January 2013
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2011
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Weight Loss

Intervention

Other:
• Energy Restriction
Energy restricted diet of 750 kcal less than subjects requirement with a high protein diet.
• Energy Restriction
Energy restricted diet of 750 kcal less than subjects requirement with a lower protein diet.

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes