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Completed

NCT Number: NCT02380833

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

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.

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Key information

Conditions

Healthy

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clemson University

Clemson, South Carolina, 29631, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MyPlate

Behavioral

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

MyPlate + Exercise

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

Behavioral

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

Paleolithic + Exercise

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Clemson University

Other

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 5, 2015
Registry last updated
Nov 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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