HealthySTEAMMNCT06547190
Study on Treating by Eating: Role of AGEs on Mucosal Barrier and Microbiome.
A study testing High AGEs diet and Low AGEs diet in people with Healthy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This is an exploratory study aimed at healthy volunteers to investigate the impact of differential cooking methods on global and gut inflammation, intestinal permeability, and the gut microbiota. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High AGEs diet and Low AGEs diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2022to 30 Jul 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overall healthy
- Adhering to an omnivorous diet
- Body Mass Index (BMI) between 18.5 - 30 kg/m2
- Able to provide consent.
Who cannot join
- Participants with chronic illnesses including diabetes mellitus, cardiovascular disease, or cancer; eating disorders, irritable bowel syndrome; inflammatory bowel diseases, and previous bowel surgery (except for appendectomy).
- Current smoking
- Participants taking nonsteroidal anti-inflammatory drugs (NSAIDS), proton pump inhibitors, antacids, or laxatives one month before enrollment or antibiotics, prebiotics or probiotics six months before the start of the trial.
- Pregnancy of lactation
Trial locations and contacts
1 site in 1 country.
About this study
This is an exploratory study aimed at healthy volunteers to investigate the impact of differential cooking methods on global and gut inflammation, intestinal permeability, and the gut microbiota. The investigators hypothesize that a short dietary intervention of baking and grilling of food for 2 weeks as opposed to steaming and boiling of food for 2 weeks will result in measurable differences in blood, stool and urine samples that guide towards gut and overall health and disease. All food will be provided, together with detailed cooking instructions. Food logs including photographs will be used to check whether participants complied with the study.
The investigators aim to better understand the role of cooking methods in human health, so that this can be implemented in preventive strategies and dietary treatments for specific patient groups.
Read the detailed description
This is a pilot project aimed at healthy volunteers to investigate the impact of differential cooking methods on systemic and intestinal inflammation, permeability, and the gut microbiota, using a randomised cross-over design. The investigators hypothesize that a short dietary intervention of baking and grilling of food for 2 weeks (high-Advanced Glycation End Products (AGEs) diet) as opposed to steaming and boiling of food for 2 weeks (low-AGEs diet) will result in measurable differences in inflammatory, cardiometabolic and microbial markers in blood and stool as well as changes in intestinal permeability through their effect on dietary AGEs. All food will be provided, together with detailed cooking instructions. Food logs including photographs will be used to assess and check adherence to the intervention.
The investigators aim to better understand the role of cooking methods and thermal treatments in human health, so that this can be implemented in preventive strategies and dietary treatments for specific patient groups.
- Conditions
- Healthy
- Being tested
- High AGEs diet, Low AGEs diet
- Keywords
- Advanced Glycation End products, Cooking Methods, Culinary Techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High AGEs dietBehavioural
Participants sequentially consumed a diet that was high in AGEs and low in AGEs just be altering their cooking method. The High AGEs diet was cooked for example by baking and grilling.
Low AGEs dietBehavioural
Participants sequentially consumed a diet that was high in AGEs and low in AGEs just be altering their cooking method. The low AGEs diet was cooked for example by steaming and boiling.
| Study group | Role | What they receive |
|---|---|---|
| HL | Experimental | High-to-Low AGEs diet Receives: Behavioral: High AGEs diet; Behavioral: Low AGEs diet |
| LH | Experimental | Low-to-High AGEs diet Receives: Behavioral: High AGEs diet; Behavioral: Low AGEs diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal inflammation
Measurement of faecal calprotectin through stool samples (in mg/kg)
Measured: 2 weeks
Gut microbial metabolism
Measurement of short chain fatty acids including acetic acid, propionic acid and butyric acid through stool samples (in mg/100g stool)
Measured: 2 weeks
Gut microbial composition
Measurement of the composition of the gut microbiota using 16s rRNA sequencing of stool samples.
Measured: 2 weeks
Intestinal transcellular permeability
Measurement of transcellular intestinal permeability using lipopolysaccharide binding protein in blood samples
Measured: 2 weeks
Intestinal paracellular permeability
Measurement of paracellular intestinal permeability using the lacultulose mannitol test using urine samples
Measured: 2 weeks
Systemic inflammation
serum inflammation through OLINK inflammatory panel (measurement of 92 proteins in blood)
Measured: 2 weeks
Systemic inflammation
Every serum CRP in blood samples (in mg/l)
Measured: 2 weeks
Systemic cardiometabolic health
serum cardiometabolic parameters through OLINK cardiometabolic panel (measurement of 92 proteins in blood)
Measured: 2 weeks
Systemic lipid profile
Total, LDL- and HDL-cholesterol values in blood samples (in mg/dl)
Measured: 2 weeks
Weight changes
weight (in kg)
Measured: 2 weeks
Handgrip strength changes
Handgrip strength (in kg)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Feb 2022
- Primary completion3 May 2022
- Study completion30 Jul 2022
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 HealthyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Model description
- Randomized Cross-over Trial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Flemish institute of biotechnology (VIB)
- Responsible party
- Principal investigator, JoaoSabino, Universitaire Ziekenhuizen KU Leuven
- Investigators
- João Sabino, MD, Principal investigator, Leuven University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547190
- Sponsor's protocol ID
- S65600
- Acronym
- STEAMM
- Status last verified
- Aug 2024
- First submitted
- 31 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To be discussed upon request.
Publications
Wellens J, Vissers E, Dumoulin A, Hoekx S, Vanderstappen J, Verbeke J, Vangoitsenhoven R, Derrien M, Verstockt B, Ferrante M, Matthys C, Raes J, Verbeke K, Vermeire S, Sabino J. Cooking methods affect advanced glycation end products and lipid profiles: A randomized cross-over study in healthy subjects. Cell Rep Med. 2025 May 20;6(5):102091. doi: 10.1016/j.xcrm.2025.102091. Epub 2025 Apr 24.
PubMed 40280130
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Treating by Eating: Role of AGEs on Mucosal Barrier and Microbiome.
- ClinicalTrials.gov ID
- NCT06547190
- Acronym / sponsor ID
- STEAMM / S65600
- Conditions
- Healthy
- Keywords
- Advanced Glycation End products, Cooking Methods, Culinary Techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Flemish institute of biotechnology (VIB)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 9 Aug 2024 (actual)
- 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.
This is an exploratory study aimed at healthy volunteers to investigate the impact of differential cooking methods on global and gut inflammation, intestinal permeability, and the gut microbiota. The investigators hypothesize that a short dietary intervention of baking and grilling of food for 2 weeks as opposed to steaming and boiling of food for 2 weeks will result in measurable differences in blood, stool and urine samples that guide towards gut and overall health and disease. All food will be provided, together with detailed cooking instructions. Food logs including photographs will be used to check whether participants complied with the study.
The investigators aim to better understand the role of cooking methods in human health, so that this can be implemented in preventive strategies and dietary treatments for specific patient groups.
Detailed description
This is a pilot project aimed at healthy volunteers to investigate the impact of differential cooking methods on systemic and intestinal inflammation, permeability, and the gut microbiota, using a randomised cross-over design. The investigators hypothesize that a short dietary intervention of baking and grilling of food for 2 weeks (high-Advanced Glycation End Products (AGEs) diet) as opposed to steaming and boiling of food for 2 weeks (low-AGEs diet) will result in measurable differences in inflammatory, cardiometabolic and microbial markers in blood and stool as well as changes in intestinal permeability through their effect on dietary AGEs. All food will be provided, together with detailed cooking instructions. Food logs including photographs will be used to assess and check adherence to the intervention.
The investigators aim to better understand the role of cooking methods and thermal treatments in human health, so that this can be implemented in preventive strategies and dietary treatments for specific patient groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Cross-over Trial
| Arm | Type | Receives |
|---|---|---|
| HL | Experimental | Behavioral: High AGEs diet, Behavioral: Low AGEs dietHigh-to-Low AGEs diet |
| LH | Experimental | Behavioral: High AGEs diet, Behavioral: Low AGEs dietLow-to-High AGEs diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Overall healthy
- Adhering to an omnivorous diet
- Body Mass Index (BMI) between 18.5 - 30 kg/m2
- Able to provide consent.
Key exclusion criteria (4 listed)
- Participants with chronic illnesses including diabetes mellitus, cardiovascular disease, or cancer; eating disorders, irritable bowel syndrome; inflammatory bowel diseases, and previous bowel surgery (except for appendectomy).
- Current smoking
- Participants taking nonsteroidal anti-inflammatory drugs (NSAIDS), proton pump inhibitors, antacids, or laxatives one month before enrollment or antibiotics, prebiotics or probiotics six months before the start of the trial.
- Pregnancy of lactation
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 |
|---|---|---|
| High AGEs dietParticipants sequentially consumed a diet that was high in AGEs and low in AGEs just be altering their cooking method. The High AGEs diet was cooked for example by baking and grilling. | Behavioural | HL, LH |
| Low AGEs dietParticipants sequentially consumed a diet that was high in AGEs and low in AGEs just be altering their cooking method. The low AGEs diet was cooked for example by steaming and boiling. | Behavioural | HL, LH |
Primary outcome
Intestinal inflammation
Time frame: 2 weeks
Measurement of faecal calprotectin through stool samples (in mg/kg)
Gut microbial metabolism
Time frame: 2 weeks
Measurement of short chain fatty acids including acetic acid, propionic acid and butyric acid through stool samples (in mg/100g stool)
Gut microbial composition
Time frame: 2 weeks
Measurement of the composition of the gut microbiota using 16s rRNA sequencing of stool samples.
Intestinal transcellular permeability
Time frame: 2 weeks
Measurement of transcellular intestinal permeability using lipopolysaccharide binding protein in blood samples
Intestinal paracellular permeability
Time frame: 2 weeks
Measurement of paracellular intestinal permeability using the lacultulose mannitol test using urine samples
Systemic inflammation
Time frame: 2 weeks
serum inflammation through OLINK inflammatory panel (measurement of 92 proteins in blood)
Systemic inflammation
Time frame: 2 weeks
Every serum CRP in blood samples (in mg/l)
Systemic cardiometabolic health
Time frame: 2 weeks
serum cardiometabolic parameters through OLINK cardiometabolic panel (measurement of 92 proteins in blood)
Systemic lipid profile
Time frame: 2 weeks
Total, LDL- and HDL-cholesterol values in blood samples (in mg/dl)
Weight changes
Time frame: 2 weeks
weight (in kg)
Handgrip strength changes
Time frame: 2 weeks
Handgrip strength (in kg)
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 9 Aug 2024.
- Derived from this study: PubMed 40280130Wellens J, Vissers E, Dumoulin A, Hoekx S, Vanderstappen J, Verbeke J, Vangoitsenhoven R, Derrien M, Verstockt B, Ferrante M, Matthys C, Raes J, Verbeke K, Vermeire S, Sabino J. Cooking methods affect advanced glycation end products and lipid profiles: A randomized cross-over study in healthy subjects. Cell Rep Med. 2025 May 20;6(5):102091. doi: 10.1016/j.xcrm.2025.102091. Epub 2025 Apr 24.
- Individual participant dataSharing planned: Yes. To be discussed upon request.
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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.
João Sabino, MD principal investigator
Leuven University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High AGEs diet and Low AGEs diet in people with Healthy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 4 inclusion and 4 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 9 Aug 2024. 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 Belgium. 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?
Intestinal inflammation (time frame: 2 weeks). The study lists 11 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 NCT06547190, 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 9 Aug 2024.