|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
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? |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| 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 |
|
weight metabolism cholesterol insulin |
|
Body Weight Signs and Symptoms Signs and Symptoms, Digestive Hyperkinesis |
Healthy Insulin Hyperphagia |
|
Signs and Symptoms Signs and Symptoms, Digestive Hyperphagia |
