Hyper-AlimentationNCT00826631
How Does 4 Weeks of Increased Fast Food Intake Affect Metabolism?
A study testing Fast food arm in people with Hyper-Alimentation and Healthy, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyper-Alimentation, Healthy
- What is being tested?
- Fast food arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2006to Jan 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy non-obese subjects
Who cannot join
- General diseases, obesity.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Hyper-Alimentation, Healthy
- Being tested
- Fast food arm
- Keywords
- weight, metabolism, cholesterol, insulin
- Medical subject headings
- Body Weight, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast food armProcedure or surgery
Doubling of regular caloric intake based on fast food, no exercise allowed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Fast food intake, doubling of caloric intake, in combination with sedentary behavior (no exercise) Receives: Procedure: Fast food arm |
| 2 | No intervention | Control group, parallel |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight gain
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startApr 2006
- Primary completionDec 2007
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hyper-AlimentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826631
- Sponsor's protocol ID
- M158-05
- Status last verified
- Jan 2009
- First submitted
- 21 Jan 2009
- Last updated
- 22 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Kechagias S, Ernersson A, Dahlqvist O, Lundberg P, Lindstrom 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. doi: 10.1136/gut.2007.131797. Epub 2008 Feb 14.
PubMed 18276725Lindstrom T, Kechagias S, Carlsson M, Nystrom FH; Fast Food Study Group. Transient increase in HDL-cholesterol during weight gain by hyperalimentation in healthy subjects. Obesity (Silver Spring). 2011 Apr;19(4):812-7. doi: 10.1038/oby.2010.190. Epub 2010 Sep 2.
PubMed 20814413
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does 4 Weeks of Increased Fast Food Intake Affect Metabolism?
- ClinicalTrials.gov ID
- NCT00826631
- Acronym / sponsor ID
- M158-05
- Conditions
- Hyper-Alimentation, Healthy
- Keywords
- weight, metabolism, cholesterol, insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 22 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Fast food armFast food intake, doubling of caloric intake, in combination with sedentary behavior (no exercise) |
| 2 | No intervention | –Control group, parallel |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy non-obese subjects
Key exclusion criteria (1 listed)
- General diseases, obesity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast food armDoubling of regular caloric intake based on fast food, no exercise allowed | Procedure or surgery | 1 |
Primary outcome
weight gain
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2009.
- Results publication: PubMed 18276725Kechagias S, Ernersson A, Dahlqvist O, Lundberg P, Lindstrom 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. doi: 10.1136/gut.2007.131797. Epub 2008 Feb 14.
- Derived from this study: PubMed 20814413Lindstrom T, Kechagias S, Carlsson M, Nystrom FH; Fast Food Study Group. Transient increase in HDL-cholesterol during weight gain by hyperalimentation in healthy subjects. Obesity (Silver Spring). 2011 Apr;19(4):812-7. doi: 10.1038/oby.2010.190. Epub 2010 Sep 2.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast food arm in people with Hyper-Alimentation and Healthy, run by University Hospital, Linkoeping at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight gain (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00826631, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2009.