NCT02380833

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
27 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

1.1 years

First QC Date

February 16, 2015

Last Update Submit

November 15, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (21)

  • Change in resting energy expenditure

    Baseline and 8 weeks

  • Change in urine

    Baseline and 8 weeks

  • Change in insulin (plasma)

    Baseline and 8 weeks

  • Change in glucagon (plasma)

    Baseline and 8 weeks

  • Change in ghrelin (plasma)

    Baseline and 8 weeks

  • +16 more secondary outcomes

Other Outcomes (3)

  • Change in free living activity

    Baseline and 8 weeks

  • Change in blood pressure

    Baseline and 8 weeks

  • Change in resting heart rate

    Baseline and 8 weeks

Study Arms (4)

MyPlate

ACTIVE COMPARATOR

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

Behavioral: MyPlate

MyPlate + Exercise

ACTIVE COMPARATOR

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

Paleolithic

ACTIVE COMPARATOR

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

Behavioral: Paleolithic

Paleolithic + Exercise

ACTIVE COMPARATOR

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

Interventions

MyPlateBEHAVIORAL

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

MyPlate
MyPlate + ExerciseBEHAVIORAL

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 + Exercise
PaleolithicBEHAVIORAL

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

Paleolithic
Paleolithic + ExerciseBEHAVIORAL

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.

Paleolithic + Exercise

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • taking any medication
  • women who have had a left breast mastectomy
  • do not meet criteria of PAR-Q

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clemson University

Clemson, South Carolina, 29631, United States

Location

MeSH Terms

Interventions

ExerciseDiet, Paleolithic

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 16, 2015

First Posted

March 5, 2015

Study Start

April 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

November 17, 2016

Record last verified: 2016-11

Locations

US(1)