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Increased Dietary Protein and Meal Frequency Reduces Total and Abdominal Body Fat During Weight Maintenance and Weight Loss (3v6)

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ClinicalTrials.gov Identifier: NCT01749449
Recruitment Status : Completed
First Posted : December 13, 2012
Last Update Posted : December 13, 2012
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Skidmore College

Brief Summary:
The purpose of the current study was to examine the impact of macronutrient intake (PRO, 15% vs. 35%) and meal frequency (3 vs. 6 meals/day) on body composition, postprandial thermogenesis and plasma adipokines before and after 28days each of EB (28days) and ED (25%; 28days) in overweight individuals. We hypothesize that HP will elicit more favorable body composition, thermogenic, and cardiometabolic changes than HC intakes and the magnitude of change will be greatest in those consuming HP meals more frequently.

Condition or disease Intervention/treatment Phase
Obesity Other: protein and meal frequency Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Increased Protein Intake and Meal Frequency Reduces Abdominal Fat and Increases Postprandial Thermogenesis During Energy Balance and Energy Deficit
Study Start Date : January 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : January 2007

Arm Intervention/treatment
Experimental: High protein 3 meals/day
35% protein intake eaten as 3 meals per day
Other: protein and meal frequency
comparison of different levels of protein intake and meal frequency on body composition in obese adults
Experimental: High carbohydrate consumed 3 meals/day
High carbohydrate 3 meals/day
Other: protein and meal frequency
comparison of different levels of protein intake and meal frequency on body composition in obese adults
Experimental: High protein consumed 6 meals/day
35% protein 6 meals/day
Other: protein and meal frequency
comparison of different levels of protein intake and meal frequency on body composition in obese adults



Primary Outcome Measures :
  1. body composition [ Time Frame: 2 months ]
    DXA was used to quantify changes in body composition over the 2 months



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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 30-65 years old,
  • overweight or obese but otherwise in good health

Exclusion Criteria:

  • cardiovascular disease,
  • cancer,
  • HTN,
  • type I or II DM,
  • food allergies

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): NCT01749449


Locations
United States, New York
Skidmore College
Saratoga Springs, New York, United States, 12866
Sponsors and Collaborators
Skidmore College
Abbott
Investigators
Principal Investigator: Paul J Arciero, PhD Skidmore College

Responsible Party: Skidmore College
ClinicalTrials.gov Identifier: NCT01749449     History of Changes
Other Study ID Numbers: 3v6-021904
First Posted: December 13, 2012    Key Record Dates
Last Update Posted: December 13, 2012
Last Verified: January 2007

Keywords provided by Skidmore College:
high protein
high carbohydrate
meal frequency
abdominal body fat
postprandial thermogenesis