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

NCT ID: NCT02380833

Last Updated: 2016-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-05-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

NONE

Study Groups

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MyPlate

To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations for eight weeks.

Group Type ACTIVE_COMPARATOR

MyPlate

Intervention Type BEHAVIORAL

To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations for eight weeks.

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.

Group Type ACTIVE_COMPARATOR

MyPlate + Exercise

Intervention Type BEHAVIORAL

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.

Paleolithic

To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations for eight weeks.

Group Type ACTIVE_COMPARATOR

Paleolithic

Intervention Type BEHAVIORAL

To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations for eight weeks.

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.

Group Type ACTIVE_COMPARATOR

Paleolithic + Exercise

Intervention Type BEHAVIORAL

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.

Interventions

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MyPlate

To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations for eight weeks.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Paleolithic

To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations for eight weeks.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Clemson University

OTHER

Sponsor Role lead

Responsible Party

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Elliot D. Jesch

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clemson University

Clemson, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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IRB2014-457

Identifier Type: -

Identifier Source: org_study_id