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

Study Overview
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Brief Summary
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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).

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

Conditions
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Weight Loss

Intervention / Treatment
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* Other: Energy Restriction
* Other: Energy Restriction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>High protein diet. | Other: Energy Restriction<br>* Energy restricted diet of 750 kcal less than subjects requirement with a high protein diet.<br>|
| Experimental: 2<br>Lower protein diet. | Other: Energy Restriction<br>* Energy restricted diet of 750 kcal less than subjects requirement with a lower protein diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |