Clinical trial NCT02380833: Effectiveness of a Paleolithic Based Diet Compared to MyPlate Guidelines, With and Without Exercise, in Women.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Clemson University
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

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.


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

Primary outcomes:
measure: Change in aerobic conditioning
timeFrame: Baseline and 8 weeks
measure: Change in anaerobic power
timeFrame: Baseline and 8 weeks
measure: Change in strength
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in resting energy expenditure
timeFrame: Baseline and 8 weeks
measure: Change in urine
timeFrame: Baseline and 8 weeks
measure: Change in insulin (plasma)
timeFrame: Baseline and 8 weeks
measure: Change in glucagon (plasma)
timeFrame: Baseline and 8 weeks
measure: Change in ghrelin (plasma)
timeFrame: Baseline and 8 weeks
measure: Change in peptide YY 3-36 (plasma)
timeFrame: Baseline and 8 weeks
measure: Change in adiponectin (plasma)
timeFrame: Baseline and 8 weeks
measure: Change in leptin (plasma)
timeFrame: Baseline and 8 weeks
measure: Change in tumor necrosis factor alpha (plasma)
timeFrame: Baseline and 8 weeks
measure: Change in interleukin 6 (plasma)
timeFrame: Baseline and 8 weeks
measure: Change in undercarboxylated osteocalcin (plasma)
timeFrame: Baseline and 8 weeks
measure: Change in total cholesterol (plasma)
timeFrame: Baseline and 8 weeks
measure: Change in HDL cholesterol (plasma)
timeFrame: Baseline and 8 weeks
measure: Change in non-HDL cholesterol (plasma)
timeFrame: Baseline and 8 weeks
measure: Change in triacylglycerol (plasma)
timeFrame: Baseline and 8 weeks
measure: Change in non-esterified fatty acids (plasma)
timeFrame: Baseline and weeks
measure: Change in glucose (plasma)
timeFrame: Baseline and 8 weeks
measure: Change in ketones (plasma)
timeFrame: Baseline and 8 weeks
measure: Change in fat mass
timeFrame: Baseline and 8 weeks
measure: Change in fat free mass
timeFrame: Baseline and 8 weeks
measure: Change in bone mass
timeFrame: Baseline and 8 weeks
Other outcomes:
measure: Change in free living activity
timeFrame: Baseline and 8 weeks
measure: Change in blood pressure
timeFrame: Baseline and 8 weeks
measure: Change in resting heart rate
timeFrame: Baseline and 8 weeks
Locations:
city: Clemson
country: United States
facility: Clemson University
state: South Carolina
Study officials:
References: