Back to resultsHow Does 4 Weeks of Increased Fast Food Intake Affect Metabolism?
Primary Purpose
Hyper-Alimentation, Healthy
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Fast food arm
Sponsored by
About this trial
This is an interventional basic science trial for Hyper-Alimentation focused on measuring weight, metabolism, cholesterol, insulin
Eligibility Criteria
Inclusion Criteria:
- Healthy non-obese subjects
Exclusion Criteria:
- General diseases, obesity.
Sites / Locations
- University Hospital of Linkoping
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
1
2
Arm Description
Fast food intake, doubling of caloric intake, in combination with sedentary behavior (no exercise)
Control group, parallel
Outcomes
Primary Outcome Measures
weight gain
Secondary Outcome Measures
Full Information
NCT ID
NCT00826631
First Posted
January 21, 2009
Last Updated
January 21, 2009
Sponsor
University Hospital, Linkoeping
1. Study Identification
Unique Protocol Identification Number
NCT00826631
Brief Title
How Does 4 Weeks of Increased Fast Food Intake Affect Metabolism?
Official Title
How Does 4 Weeks of Increased Fast Food Intake Affect Metabolism?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Linkoeping
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objective: To study the effect of fast food-based hyper-alimentation on liver enzymes and hepatic triglyceride content (HTGC)and metabolism.
Design: Prospective interventional study with parallel control group. Setting University Hospital of Linköping, Sweden. Participants: 12 healthy men and six healthy women with a mean (SD) age of 26 (6.6) years and a matched control group.
Intervention: Subjects in the intervention group aimed for a body weight increase of 5-15% by eating at least two fast food-based meals a day with the goal to double the regular caloric intake in combination with adoption of a sedentary lifestyle for four weeks.
Main outcome measures: Weekly changes of serum aminotransferases and HTGC measured by proton nuclear magnetic resonance-spectroscopy at baseline and after the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyper-Alimentation, Healthy
Keywords
weight, metabolism, cholesterol, insulin
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Fast food intake, doubling of caloric intake, in combination with sedentary behavior (no exercise)
Arm Title
2
Arm Type
No Intervention
Arm Description
Control group, parallel
Intervention Type
Procedure
Intervention Name(s)
Fast food arm
Intervention Description
Doubling of regular caloric intake based on fast food, no exercise allowed
Primary Outcome Measure Information:
Title
weight gain
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy non-obese subjects
Exclusion Criteria:
General diseases, obesity.
Facility Information:
Facility Name
University Hospital of Linkoping
City
Linkoping
ZIP/Postal Code
58185
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
18276725
Citation
Kechagias S, Ernersson A, Dahlqvist O, Lundberg P, Lindstrom T, Nystrom FH; Fast Food Study Group. Fast-food-based hyper-alimentation can induce rapid and profound elevation of serum alanine aminotransferase in healthy subjects. Gut. 2008 May;57(5):649-54. doi: 10.1136/gut.2007.131797. Epub 2008 Feb 14.
Results Reference
result
PubMed Identifier
20814413
Citation
Lindstrom T, Kechagias S, Carlsson M, Nystrom FH; Fast Food Study Group. Transient increase in HDL-cholesterol during weight gain by hyperalimentation in healthy subjects. Obesity (Silver Spring). 2011 Apr;19(4):812-7. doi: 10.1038/oby.2010.190. Epub 2010 Sep 2.
Results Reference
derived
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How Does 4 Weeks of Increased Fast Food Intake Affect Metabolism?
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