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OpenTrials
Completed

NCT Number: NCT00812162

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

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).

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Key information

Age range

21 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University

West Lafayette, Indiana, 47907, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Energy restriction

Other

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

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.

    Time frame: 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.

    Time frame: 12 week

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2011
First posted
Dec 22, 2008
Registry last updated
Jan 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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