- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01749449
Increased Dietary Protein and Meal Frequency Reduces Total and Abdominal Body Fat During Weight Maintenance and Weight Loss (3v6)
December 12, 2012 updated by: Skidmore College
Increased Protein Intake and Meal Frequency Reduces Abdominal Fat and Increases Postprandial Thermogenesis During Energy Balance and Energy Deficit
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Saratoga Springs, New York, United States, 12866
- Skidmore College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High protein 3 meals/day
35% protein intake eaten as 3 meals per day
|
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
|
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
|
comparison of different levels of protein intake and meal frequency on body composition in obese adults
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
body composition
Time Frame: 2 months
|
DXA was used to quantify changes in body composition over the 2 months
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
May 1, 2006
Study Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
December 11, 2012
First Submitted That Met QC Criteria
December 12, 2012
First Posted (Estimate)
December 13, 2012
Study Record Updates
Last Update Posted (Estimate)
December 13, 2012
Last Update Submitted That Met QC Criteria
December 12, 2012
Last Verified
January 1, 2007
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 3v6-021904
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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