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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Behavioral: MyPlate + Exercise; Behavioral: MyPlate; Behavioral: Paleolithic; Behavioral: Paleolithic + Exercise

• Registration Number: NCT02380833
• Lead Sponsor: Clemson University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-16
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-05
• Study Start: 2015-04
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-15
• Last Update Posted: 2016-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
MyPlate + Exercise	MyPlate + Exercise	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.
MyPlate	MyPlate	To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations for eight weeks.
Paleolithic	Paleolithic	To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations for eight weeks.
Paleolithic + Exercise	Paleolithic + Exercise	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.

Primary Outcome Measures

Name	Time	Method
Change in anaerobic power	Baseline and 8 weeks	Wingate anaerobic threshold
Change in aerobic conditioning	Baseline and 8 weeks	Peak oxygen consumption
Change in strength	Baseline and 8 weeks	Chest press and leg press estimated one repetition maximum

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clemson University; 🇺🇸 Clemson, South Carolina, United States