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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Skidmore College
ClinicalTrials.gov Identifier:
NCT01749449
First received: December 11, 2012
Last updated: December 12, 2012
Last verified: January 2007
  Purpose

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 Intervention
Obesity
Other: protein and meal frequency

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Skidmore College:

Primary Outcome Measures:
  • body composition [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    DXA was used to quantify changes in body composition over the 2 months


Enrollment: 30
Study Start Date: January 2005
Study Completion Date: January 2007
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Skidmore College
ClinicalTrials.gov Identifier: NCT01749449     History of Changes
Other Study ID Numbers: 3v6-021904
Study First Received: December 11, 2012
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014