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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT00826631
First received: January 21, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  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: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: How Does 4 Weeks of Increased Fast Food Intake Affect Metabolism?

Resource links provided by NLM:


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
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

  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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00826631     History of Changes
Other Study ID Numbers: M158-05
Study First Received: January 21, 2009
Last Updated: January 21, 2009
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University Hospital, Linkoeping:
weight
metabolism
cholesterol
insulin

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

ClinicalTrials.gov processed this record on April 15, 2014