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

U

University Hospital, Linkoeping

Status

Completed

Conditions

Healthy
Hyper-Alimentation

Treatments

Procedure: Fast food arm

Study type

Interventional

Funder types

Other

Identifiers

NCT00826631
M158-05

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy non-obese subjects

Exclusion criteria

  • General diseases, obesity.

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

36 participants in 2 patient groups

1
Active Comparator group
Description:
Fast food intake, doubling of caloric intake, in combination with sedentary behavior (no exercise)
Treatment:
Procedure: Fast food arm
2
No Intervention group
Description:
Control group, parallel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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