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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 20, 2014