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NCT00826631 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00826631
Other study ID # M158-05
Secondary ID
Status Completed
Phase N/A
First received January 21, 2009
Last updated January 21, 2009
Start date April 2006
Est. completion date January 2009

Study information
Verified date January 2009
Source University Hospital, Linkoeping
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date January 2009
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Healthy non-obese subjects

Exclusion Criteria:

- General diseases, obesity.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Procedure:
• Fast food arm
Doubling of regular caloric intake based on fast food, no exercise allowed

Locations
Country Name City State
Sweden University Hospital of Linkoping Linkoping

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Kechagias S, Ernersson A, Dahlqvist O, Lundberg P, Lindström 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 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary weight gain 1 month No
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