Healthy
Conditions
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.
Interventions
BEHAVIORALMyPlate
To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations for eight weeks.
BEHAVIORALMyPlate + 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.
BEHAVIORALPaleolithic
To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations for eight weeks.
BEHAVIORALPaleolithic + 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.
Sponsors
Clemson University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in leptin (plasma) | Baseline and 8 weeks | 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 HDL cholesterol (plasma) | Baseline and 8 weeks | Colorimetric enzyme assay |
| Change in resting energy expenditure | Baseline and 8 weeks | 24 hour kcal and respiratory quotient |
| Change in urine | Baseline and 8 weeks | Osmolality |
| Change in glucagon (plasma) | Baseline and 8 weeks | Radioimmunoprecipitation assay |
| Change in ghrelin (plasma) | Baseline and 8 weeks | Total and active ghrelin; Radioimmunoprecipitation assay |
| Change in non-HDL cholesterol (plasma) | Baseline and 8 weeks | Calculated from triacylglycerol, total cholesterol and HDL cholesterol |
| Change in triacylglycerol (plasma) | Baseline and 8 weeks | Colorimetric enzyme assay |
| Change in non-esterified fatty acids (plasma) | Baseline and weeks | Colorimetric enzyme assay |
| Change in glucose (plasma) | Baseline and 8 weeks | Colorimetric enzyme assay |
| Change in ketones (plasma) | Baseline and 8 weeks | Colorimetric enzyme assay |
| Change in fat mass | Baseline and 8 weeks | Dual energy x-ray absorptiometry |
| Change in fat free 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 insulin (plasma) | Baseline and 8 weeks | Radioimmunoprecipitation assay |
| Change in peptide YY 3-36 (plasma) | Baseline and 8 weeks | Radioimmunoprecipitation assay |
| Change in adiponectin (plasma) | Baseline and 8 weeks | Radioimmunoprecipitation assay |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in free living activity | Baseline and 8 weeks | Armband activity monitor worn on the upper left arm (METs) |
| Change in resting heart rate | Baseline and 8 weeks | Beats per minute |
| Change in blood pressure | Baseline and 8 weeks | Systolic and diastolic blood pressure |
Countries
United States
Outcome results
None listed