How Does 4 Weeks of Increased Fast Food Intake Affect Metabolism?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00826631
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : January 22, 2009
Information provided by:
University Hospital, Linkoeping

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.

Condition or disease Intervention/treatment Phase
Hyper-Alimentation Healthy Procedure: Fast food arm Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: How Does 4 Weeks of Increased Fast Food Intake Affect Metabolism?
Study Start Date : April 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Fast food intake, doubling of caloric intake, in combination with sedentary behavior (no exercise)
Procedure: Fast food arm
Doubling of regular caloric intake based on fast food, no exercise allowed
No Intervention: 2
Control group, parallel

Primary Outcome Measures :
  1. weight gain [ Time Frame: 1 month ]

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy non-obese subjects

Exclusion Criteria:

  • General diseases, obesity.

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 identifier (NCT number): NCT00826631

University Hospital of Linkoping
Linkoping, Sweden, 58185
Sponsors and Collaborators
University Hospital, Linkoeping

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00826631     History of Changes
Other Study ID Numbers: M158-05
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: January 22, 2009
Last Verified: January 2009

Keywords provided by University Hospital, Linkoeping:

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms