ObesityAGE-1NCT01434407
Effects of Advanced Glycation Endproducts on Satiety and Inflammation
A study testing Dietary meal intervention in people with Obesity and Type 2 Diabetes, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The purpose of the meal study is to investigate acute effects on satiety and inflammation of advanced glycation endproducts (AGE) in healthy overweight subjects. The AGE content of the meal is affected by food preparation methods: frying/grilling versus boiling/steaming. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes, Insulin Resistance
- What is being tested?
- Dietary meal intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2011to Mar 2012
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females between 20 and 50 years old
- BMI 25-40
- Waist circumference above 88 cm for women and above 102 cm for men
Who cannot join
- Exercise training above 8 hour/week
- Smoking
- Pregnant or breast-feeding women
- Post-menstrual women
- Regular use of medicine (except contraceptive pills)
- Previous gastric bypass surgery
Show all 9Show fewer
- Donation of blood within the last 3 months
- Involvement in other clinical trials
- Allergic to paraaminobenzoic acid
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Human Nutrition, University of Copenhagen
Copenhagen, Frederiksberg C, 1958
About this study
Official title: Crossover Meal Study Investigating Effects of Advanced Glycation Endproducts on Satiety and Inflammation
The purpose of the meal study is to investigate acute effects on satiety and inflammation of advanced glycation endproducts (AGE) in healthy overweight subjects. The AGE content of the meal is affected by food preparation methods: frying/grilling versus boiling/steaming.
- Conditions
- Obesity, Type 2 Diabetes, Insulin Resistance, Cardiovascular Disease
- Being tested
- Dietary meal intervention
- Keywords
- Advanced glycation endproducts, Satiety, Obesity, Inflammation, Insulin resistance
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Insulin Resistance, Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary meal interventionOther
Test meals with different AGE content made by different cooking methods
| Study group | Role | What they receive |
|---|---|---|
| Low AGE meal | Experimental | Test meal prepared by boiling/steaming the food Receives: Other: Dietary meal intervention |
| High AGE meal | Experimental | Test meal prepared by frying/grilling the food Receives: Other: Dietary meal intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite sensation
Appetite sensation measured by visual analogue scales
Measured: Every 30 min up to 5 hours after test meal
Plasma ghrelin
Measured: Continuous measurement up to 5 hours after test meal
Plasma GLP-1
Measured: Continuous measurements up to 5 hours after test meal
Plasma PYY
Measured: Continuous measurements up to 5 hours after test meal
Plasma insulin
Measured: Continuous measurements up to 5 hours after test meal
Plasma glucose
Measured: Continuous measurements up to 5 hours after test meal
Urine AGE
Measured: From 24 hour before to 48 hour after test meal
Secondary outcomes (11)
Plasma triglycerides
Measured: Continuous measurements up to 5 hours after test meal
Expression of genes related to AGE
Measured: Continuous measurements up to 24 hours after test meal
IL-1 beta
Measured: Continuous measurements up to 5 hours after test meal
IL-6
Measured: Continuous measurements up to 5 hours after test meal
TNF-alpha
Measured: Continuous measurements up to 5 hours after test meal
CRP
Measured: Continuous measurements up to 5 hours after test meal
VCAM
Measured: Continuous measurements up to 5 hours after test meal
ICAM
Measured: Continuous measurements up to 5 hours after test meal
MIF
Measured: Continuous measurements up to 5 hours after test meal
Plasma AGE
Measured: Continuous measurements up to 48 hours after test meal
Urine isoprostanes
Measured: From 24 hour before to 24 hours after test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark
- Responsible party
- Principal investigator, AAstrup, University of Copenhagen
- Investigators
- Susanne G Bügel, Principal investigator, Department of Human Nutrition, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434407
- Sponsor's protocol ID
- M200
- Acronym
- AGE-1
- Status last verified
- Sep 2012
- First submitted
- 13 Sep 2011
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Poulsen MW, Bak MJ, Andersen JM, Monosik R, Giraudi-Futin AC, Holst JJ, Nielsen J, Lauritzen L, Larsen LH, Bugel S, Dragsted LO. Effect of dietary advanced glycation end products on postprandial appetite, inflammation, and endothelial activation in healthy overweight individuals. Eur J Nutr. 2014;53(2):661-72. doi: 10.1007/s00394-013-0574-y. Epub 2013 Aug 9.
PubMed 23929260
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crossover Meal Study Investigating Effects of Advanced Glycation Endproducts on Satiety and Inflammation
- ClinicalTrials.gov ID
- NCT01434407
- Acronym / sponsor ID
- AGE-1 / M200
- Conditions
- Obesity, Type 2 Diabetes, Insulin Resistance, Cardiovascular Disease
- Keywords
- Advanced glycation endproducts, Satiety, Obesity, Inflammation, Insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark
- Study start
- Aug 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 14 Sep 2011 (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.
The purpose of the meal study is to investigate acute effects on satiety and inflammation of advanced glycation endproducts (AGE) in healthy overweight subjects. The AGE content of the meal is affected by food preparation methods: frying/grilling versus boiling/steaming.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low AGE meal | Experimental | Other: Dietary meal interventionTest meal prepared by boiling/steaming the food |
| High AGE meal | Experimental | Other: Dietary meal interventionTest meal prepared by frying/grilling the food |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males and females between 20 and 50 years old
- BMI 25-40
- Waist circumference above 88 cm for women and above 102 cm for men
Key exclusion criteria (9 listed)
- Exercise training above 8 hour/week
- Smoking
- Pregnant or breast-feeding women
- Post-menstrual women
- Regular use of medicine (except contraceptive pills)
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 |
|---|---|---|
| Dietary meal interventionTest meals with different AGE content made by different cooking methods | Other | High AGE meal, Low AGE meal |
Primary outcome
Appetite sensation
Time frame: Every 30 min up to 5 hours after test meal
Appetite sensation measured by visual analogue scales
Plasma ghrelin
Time frame: Continuous measurement up to 5 hours after test meal
Plasma GLP-1
Time frame: Continuous measurements up to 5 hours after test meal
Plasma PYY
Time frame: Continuous measurements up to 5 hours after test meal
Plasma insulin
Time frame: Continuous measurements up to 5 hours after test meal
Plasma glucose
Time frame: Continuous measurements up to 5 hours after test meal
Urine AGE
Time frame: From 24 hour before to 48 hour after test meal
11 secondary outcomes
Plasma triglycerides
Time frame: Continuous measurements up to 5 hours after test meal
Expression of genes related to AGE
Time frame: Continuous measurements up to 24 hours after test meal
IL-1 beta
Time frame: Continuous measurements up to 5 hours after test meal
IL-6
Time frame: Continuous measurements up to 5 hours after test meal
TNF-alpha
Time frame: Continuous measurements up to 5 hours after test meal
CRP
Time frame: Continuous measurements up to 5 hours after test meal
VCAM
Time frame: Continuous measurements up to 5 hours after test meal
ICAM
Time frame: Continuous measurements up to 5 hours after test meal
MIF
Time frame: Continuous measurements up to 5 hours after test meal
Plasma AGE
Time frame: Continuous measurements up to 48 hours after test meal
Urine isoprostanes
Time frame: From 24 hour before to 24 hours after test meal
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 5 Sep 2012.
- Derived from this study: PubMed 23929260Poulsen MW, Bak MJ, Andersen JM, Monosik R, Giraudi-Futin AC, Holst JJ, Nielsen J, Lauritzen L, Larsen LH, Bugel S, Dragsted LO. Effect of dietary advanced glycation end products on postprandial appetite, inflammation, and endothelial activation in healthy overweight individuals. Eur J Nutr. 2014;53(2):661-72. doi: 10.1007/s00394-013-0574-y. Epub 2013 Aug 9.
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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.
Susanne G Bügel principal investigator
Department of Human Nutrition, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary meal intervention in people with Obesity and Type 2 Diabetes, run by University of Copenhagen at 1 site in Denmark.
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 3 inclusion and 9 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 5 Sep 2012. 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 Denmark. 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?
Appetite sensation (time frame: Every 30 min up to 5 hours after test meal). The study lists 7 primary outcomes in all. 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 NCT01434407, which also lists 1 linked publication.
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 5 Sep 2012.