How Does 4 Weeks of Increased Fast Food Intake Affect Metabolism? - Full Text View

Sponsor:	University Hospital, Linkoeping
Information provided by:	University Hospital, Linkoeping
ClinicalTrials.gov Identifier:	NCT00826631

Purpose

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	Intervention
Hyper-Alimentation Healthy	Procedure: Fast food arm

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Parallel Assignment
Official Title:	How Does 4 Weeks of Increased Fast Food Intake Affect Metabolism?

Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:

weight gain [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment:	36
Study Start Date:	April 2006
Study Completion Date:	January 2009
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: No Intervention Control group, parallel

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy non-obese subjects

Exclusion Criteria:

General diseases, obesity.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826631

Locations

Sweden
University Hospital of Linkoping
Linkoping, Sweden, 58185

Sponsors and Collaborators

University Hospital, Linkoeping

More Information

Publications:

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. Epub 2008 Feb 14.

Study ID Numbers:	M158-05
Study First Received:	January 21, 2009
Last Updated:	January 21, 2009
ClinicalTrials.gov Identifier:	NCT00826631 History of Changes
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by University Hospital, Linkoeping:

weight
metabolism
cholesterol
insulin

Additional relevant MeSH terms:

Signs and Symptoms
Signs and Symptoms, Digestive
Hyperphagia

ClinicalTrials.gov processed this record on November 20, 2009