Effectiveness of a Paleolithic Based Diet Compared to MyPlate Guidelines, With and Without Exercise, in Women.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of recommending either a Paleolithic based diet or the United States Department of Agriculture MyPlate guidelines with or without exercise on physical conditioning, hormones related to energy metabolism, body composition, resting energy expenditure, blood biomarkers, and urine in young, adult females.

Official Title
-----------------
The Effectiveness of a Paleolithic Based Diet Compared to MyPlate Guidelines, With and Without Exercise, on Physical Conditioning in Women: a Randomized Controlled Trial.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Behavioral: MyPlate
* Behavioral: MyPlate + Exercise
* Behavioral: Paleolithic
* Behavioral: Paleolithic + Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: body fat percent between 20 and 38 less than 150 minutes of exercise per week at 4.5 or greater Metabolic Equivalent of Task not pregnant, trying to become pregnant or lactating non-smoker no previous resistance training have not been on a diet in the past three months no dietary restrictions (food allergies, disease conditions, etc) have not lost more than 10 lbs. in the past three months Exclusion Criteria: taking any medication women who have had a left breast mastectomy do not meet criteria of PAR-Q

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MyPlate<br>To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations for eight weeks. | Behavioral: MyPlate<br>* To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations for eight weeks.<br>|
| Active Comparator: MyPlate + Exercise<br>To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations and aerobic and resistance training four days per week for eight weeks. | Behavioral: MyPlate + Exercise<br>* To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations and aerobic and resistance training four days per week for eight weeks.<br>|
| Active Comparator: Paleolithic<br>To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations for eight weeks. | Behavioral: Paleolithic<br>* To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations for eight weeks.<br>|
| Active Comparator: Paleolithic + Exercise<br>To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations and aerobic and resistance training four days per week for eight weeks. | Behavioral: Paleolithic + Exercise<br>* To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations and aerobic and resistance training four days per week for eight weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in aerobic conditioning | Peak oxygen consumption | Baseline and 8 weeks | 
| Change in anaerobic power | Wingate anaerobic threshold | Baseline and 8 weeks | 
| Change in strength | Chest press and leg press estimated one repetition maximum | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in resting energy expenditure | 24 hour kcal and respiratory quotient | Baseline and 8 weeks | 
| Change in urine | Osmolality | Baseline and 8 weeks | 
| Change in insulin (plasma) | Radioimmunoprecipitation assay | Baseline and 8 weeks | 
| Change in glucagon (plasma) | Radioimmunoprecipitation assay | Baseline and 8 weeks | 
| Change in ghrelin (plasma) | Total and active ghrelin; Radioimmunoprecipitation assay | Baseline and 8 weeks | 
| Change in peptide YY 3-36 (plasma) | Radioimmunoprecipitation assay | Baseline and 8 weeks | 
| Change in adiponectin (plasma) | Radioimmunoprecipitation assay | Baseline and 8 weeks | 
| Change in leptin (plasma) | Radioimmunoprecipitation assay | Baseline and 8 weeks | 
| Change in tumor necrosis factor alpha (plasma) | ELISA | Baseline and 8 weeks | 
| Change in interleukin 6 (plasma) | ELISA | Baseline and 8 weeks | 
| Change in undercarboxylated osteocalcin (plasma) | enzymeimmunoassay | Baseline and 8 weeks | 
| Change in total cholesterol (plasma) | Colorimetric enzyme assay | Baseline and 8 weeks | 
| Change in HDL cholesterol (plasma) | Colorimetric enzyme assay | Baseline and 8 weeks | 
| Change in non-HDL cholesterol (plasma) | Calculated from triacylglycerol, total cholesterol and HDL cholesterol | Baseline and 8 weeks | 
| Change in triacylglycerol (plasma) | Colorimetric enzyme assay | Baseline and 8 weeks | 
| Change in non-esterified fatty acids (plasma) | Colorimetric enzyme assay | Baseline and weeks | 
| Change in glucose (plasma) | Colorimetric enzyme assay | Baseline and 8 weeks | 
| Change in ketones (plasma) | Colorimetric enzyme assay | Baseline and 8 weeks | 
| Change in fat mass | Dual energy x-ray absorptiometry | Baseline and 8 weeks | 
| Change in fat free mass | Dual energy x-ray absorptiometry | Baseline and 8 weeks | 
| Change in bone mass | Dual energy x-ray absorptiometry | Baseline and 8 weeks |