ObesityAge-2NCT01617304
Effects of Food Cooking on Diabetes-2 Risk Factors
A study testing Dietary intervention in people with Obesity and Type 2 Diabetes, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The aim of the project is to investigate the effects of advanced glycation end products (AGEs) formed in food during the cooking process as well as AGEs formed naturally in the human body, on insulin sensitivity and risk factors for type 2 diabetes. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes, Insulin Resistance
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2011to Jun 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women, healthy between 20 and 50 y
- BMI between 25 and 40 kg/m2
- weight circumference over 88 cm
Who cannot join
- weigh changes within the last 2 months more than +/- 3 kg
- Physical activity more than 8 h per week
- smoking
- medications and supplements
- being vegetarian or vegan
- pregnancy or breast feeding
Show all 12Show fewer
- postmenopause
- chronic disease
- previous gastric bypass surgery
- blood donation 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
Frederiksberg
About this study
The aim of the project is to investigate the effects of advanced glycation end products (AGEs) formed in food during the cooking process as well as AGEs formed naturally in the human body, on insulin sensitivity and risk factors for type 2 diabetes. The hypothesis is that i) food content of AGEs is lower using boiling and steaming cooking methods and that ii) AGEs formation in the body is lower at low dietary intake of certain sugar forms.
- Conditions
- Obesity, Type 2 Diabetes, Insulin Resistance, Cardiovascular Disease
- Being tested
- Dietary intervention
- Keywords
- advanced glycation end products, insulin sensitivity, obesity, inflammation, metabolomics, appetite, CVD
- 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 interventionOther
Food made by different cooking methods (boiling/steaming versus frying) and with glucose or fructose water solution
| Study group | Role | What they receive |
|---|---|---|
| low AGE, glucose | Experimental | Food prepared by boiling/steaming and 20 g of glucose 3 times a day in a water solution Receives: Other: Dietary intervention |
| low AGE, fructose | Experimental | Food prepared by boiling/steaming and 20 g of fructose 3 times a day in a water solution Receives: Other: Dietary intervention |
| high AGE, fructose | Experimental | Food prepared by frying/baking and 20 g of fructose 3 times a day in a water solution Receives: Other: Dietary intervention |
| high AGE, glucose | Experimental | Food prepared by frying/baking and 20 g of glucose 3 times a day in a water solution Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in HOMA from baseline to 4 weeks
insulin sensitivity
Measured: 0 and 4 weeks
change in OGTT from baseline to 4 weeks
insulin sensitivity
Measured: 0 and 4 weeks at 0 and 120 min
change in appetite hormones (leptin, adiponectin, GLP-1, glukagon, ghrelin) from baseline to 4 weeks
Measured: 0 and 4 weeks
change in plasma and urin AGEs from baseline to 4 weeks
Measured: 0 and 4 weeks
change in immune response (CRP, C-peptide, IL-1B, IL-6, VCAM, ICAM, MIF, TNF-a, buffycoat) from baseline to 4 weeks
Measured: 0 and 4 weeks
change in metabolomics dats from baseline to 4 weeks
Measured: 0 and 4 weeks
change in AGE levels in skin from baseline to 4 weeks
Measured: 0 and 4 weeks
Secondary outcomes (2)
change in lipid profile (TG, Chol, LDL, HDL, ox LDL, glycated LDL, fattyacids)from baseline to 4 weeks
Measured: 0 and 4 weeks
change in HbA1c from baseline to 4 weeks
Measured: 0 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startDec 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
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 Bugel, Principal investigator, Department of Human Nutrition, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617304
- Sponsor's protocol ID
- M201
- Acronym
- Age-2
- Status last verified
- Jan 2013
- First submitted
- 22 Feb 2012
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Food Cooking on Diabetes-2 Risk Factors
- ClinicalTrials.gov ID
- NCT01617304
- Acronym / sponsor ID
- Age-2 / M201
- Conditions
- Obesity, Type 2 Diabetes, Insulin Resistance, Cardiovascular Disease
- Keywords
- advanced glycation end products, insulin sensitivity, obesity, inflammation, metabolomics, appetite, CVD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 12 Jun 2012 (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 aim of the project is to investigate the effects of advanced glycation end products (AGEs) formed in food during the cooking process as well as AGEs formed naturally in the human body, on insulin sensitivity and risk factors for type 2 diabetes. The hypothesis is that i) food content of AGEs is lower using boiling and steaming cooking methods and that ii) AGEs formation in the body is lower at low dietary intake of certain sugar forms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| low AGE, glucose | Experimental | Other: Dietary interventionFood prepared by boiling/steaming and 20 g of glucose 3 times a day in a water solution |
| low AGE, fructose | Experimental | Other: Dietary interventionFood prepared by boiling/steaming and 20 g of fructose 3 times a day in a water solution |
| high AGE, fructose | Experimental | Other: Dietary interventionFood prepared by frying/baking and 20 g of fructose 3 times a day in a water solution |
| high AGE, glucose | Experimental | Other: Dietary interventionFood prepared by frying/baking and 20 g of glucose 3 times a day in a water solution |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women, healthy between 20 and 50 y
- BMI between 25 and 40 kg/m2
- weight circumference over 88 cm
Key exclusion criteria (12 listed)
- weigh changes within the last 2 months more than +/- 3 kg
- Physical activity more than 8 h per week
- smoking
- medications and supplements
- being vegetarian or vegan
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 interventionFood made by different cooking methods (boiling/steaming versus frying) and with glucose or fructose water solution | Other | high AGE, fructose, high AGE, glucose, low AGE, fructose, low AGE, glucose |
Primary outcome
change in HOMA from baseline to 4 weeks
Time frame: 0 and 4 weeks
insulin sensitivity
change in OGTT from baseline to 4 weeks
Time frame: 0 and 4 weeks at 0 and 120 min
insulin sensitivity
change in appetite hormones (leptin, adiponectin, GLP-1, glukagon, ghrelin) from baseline to 4 weeks
Time frame: 0 and 4 weeks
change in plasma and urin AGEs from baseline to 4 weeks
Time frame: 0 and 4 weeks
change in immune response (CRP, C-peptide, IL-1B, IL-6, VCAM, ICAM, MIF, TNF-a, buffycoat) from baseline to 4 weeks
Time frame: 0 and 4 weeks
change in metabolomics dats from baseline to 4 weeks
Time frame: 0 and 4 weeks
change in AGE levels in skin from baseline to 4 weeks
Time frame: 0 and 4 weeks
2 secondary outcomes
change in lipid profile (TG, Chol, LDL, HDL, ox LDL, glycated LDL, fattyacids)from baseline to 4 weeks
Time frame: 0 and 4 weeks
change in HbA1c from baseline to 4 weeks
Time frame: 0 and 4 weeks
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 10 Jan 2013.
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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 Bugel 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 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 12 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 10 Jan 2013. 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?
change in HOMA from baseline to 4 weeks (time frame: 0 and 4 weeks). 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?
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 10 Jan 2013.