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

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ClinicalTrials.gov Identifier: NCT02380833
Recruitment Status : Completed
First Posted : March 5, 2015
Last Update Posted : November 17, 2016
Sponsor:
Information provided by (Responsible Party):
Elliot D. Jesch, 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.

Condition or disease Intervention/treatment Phase
Healthy Behavioral: MyPlate Behavioral: MyPlate + Exercise Behavioral: Paleolithic Behavioral: Paleolithic + Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
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 Start Date : April 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: MyPlate
To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations for eight weeks.
Behavioral: MyPlate
To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations for eight weeks.

Active Comparator: 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.
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.

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

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. Change in aerobic conditioning [ Time Frame: Baseline and 8 weeks ]
    Peak oxygen consumption

  2. Change in anaerobic power [ Time Frame: Baseline and 8 weeks ]
    Wingate anaerobic threshold

  3. Change in strength [ Time Frame: Baseline and 8 weeks ]
    Chest press and leg press estimated one repetition maximum


Secondary Outcome Measures :
  1. Change in resting energy expenditure [ Time Frame: Baseline and 8 weeks ]
    24 hour kcal and respiratory quotient

  2. Change in urine [ Time Frame: Baseline and 8 weeks ]
    Osmolality

  3. Change in insulin (plasma) [ Time Frame: Baseline and 8 weeks ]
    Radioimmunoprecipitation assay

  4. Change in glucagon (plasma) [ Time Frame: Baseline and 8 weeks ]
    Radioimmunoprecipitation assay

  5. Change in ghrelin (plasma) [ Time Frame: Baseline and 8 weeks ]
    Total and active ghrelin; Radioimmunoprecipitation assay

  6. Change in peptide YY 3-36 (plasma) [ Time Frame: Baseline and 8 weeks ]
    Radioimmunoprecipitation assay

  7. Change in adiponectin (plasma) [ Time Frame: Baseline and 8 weeks ]
    Radioimmunoprecipitation assay

  8. Change in leptin (plasma) [ Time Frame: Baseline and 8 weeks ]
    Radioimmunoprecipitation assay

  9. Change in tumor necrosis factor alpha (plasma) [ Time Frame: Baseline and 8 weeks ]
    ELISA

  10. Change in interleukin 6 (plasma) [ Time Frame: Baseline and 8 weeks ]
    ELISA

  11. Change in undercarboxylated osteocalcin (plasma) [ Time Frame: Baseline and 8 weeks ]
    enzymeimmunoassay

  12. Change in total cholesterol (plasma) [ Time Frame: Baseline and 8 weeks ]
    Colorimetric enzyme assay

  13. Change in HDL cholesterol (plasma) [ Time Frame: Baseline and 8 weeks ]
    Colorimetric enzyme assay

  14. Change in non-HDL cholesterol (plasma) [ Time Frame: Baseline and 8 weeks ]
    Calculated from triacylglycerol, total cholesterol and HDL cholesterol

  15. Change in triacylglycerol (plasma) [ Time Frame: Baseline and 8 weeks ]
    Colorimetric enzyme assay

  16. Change in non-esterified fatty acids (plasma) [ Time Frame: Baseline and weeks ]
    Colorimetric enzyme assay

  17. Change in glucose (plasma) [ Time Frame: Baseline and 8 weeks ]
    Colorimetric enzyme assay

  18. Change in ketones (plasma) [ Time Frame: Baseline and 8 weeks ]
    Colorimetric enzyme assay

  19. Change in fat mass [ Time Frame: Baseline and 8 weeks ]
    Dual energy x-ray absorptiometry

  20. Change in fat free mass [ Time Frame: Baseline and 8 weeks ]
    Dual energy x-ray absorptiometry

  21. Change in bone mass [ Time Frame: Baseline and 8 weeks ]
    Dual energy x-ray absorptiometry


Other Outcome Measures:
  1. Change in free living activity [ Time Frame: Baseline and 8 weeks ]
    Armband activity monitor worn on the upper left arm (METs)

  2. Change in blood pressure [ Time Frame: Baseline and 8 weeks ]
    Systolic and diastolic blood pressure

  3. Change in resting heart rate [ Time Frame: Baseline and 8 weeks ]
    Beats per minute



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02380833


Locations
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United States, South Carolina
Clemson University
Clemson, South Carolina, United States, 29631
Sponsors and Collaborators
Clemson University

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Responsible Party: Elliot D. Jesch, Assistant Professor, Clemson University
ClinicalTrials.gov Identifier: NCT02380833     History of Changes
Other Study ID Numbers: IRB2014-457
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: November 2016