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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wayne Campbell, Purdue University
ClinicalTrials.gov Identifier:
NCT00812162
First received: December 18, 2008
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Dietary Pork and Egg on Appetite, Meal-patterning, and Weight Loss in Men

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 48
Study Start Date: January 2007
Study Completion Date: July 2011
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
High protein diet.
 Other: Energy Restriction
Energy restricted diet of 750 kcal less than subjects requirement with a high protein diet.
Experimental: 2
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
Investigators
Principal Investigator: Wayne W Campbell, Ph.D. Purdue University
  More Information

No publications provided

Responsible Party: Wayne Campbell, Wayne Campbell, Ph.D., Purdue University
ClinicalTrials.gov Identifier: NCT00812162     History of Changes
Other Study ID Numbers: 0610004602, Pork Board 1320067860, Egg Board 1320067903
Study First Received: December 18, 2008
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013