Clinical trial NCT06547190: Study on Treating by Eating: Role of AGEs on Mucosal Barrier and Microbiome.
Official title: Study on Treating by Eating: Role of AGEs on Mucosal Barrier and Microbiome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Advanced Glycation End products
Cooking Methods
Culinary Techniques
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Vlaams Instituut voor Biotechnologie (VIB)
First posted: 2024-08-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized Cross-over Trial
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Overall healthy
* Adhering to an omnivorous diet
* Body Mass Index (BMI) between 18.5 - 30 kg/m2
* Able to provide consent.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Intestinal inflammation
timeFrame: 2 weeks
measure: Gut microbial metabolism
timeFrame: 2 weeks
measure: Gut microbial composition
timeFrame: 2 weeks
measure: Intestinal transcellular permeability
timeFrame: 2 weeks
measure: Intestinal paracellular permeability
timeFrame: 2 weeks
measure: Systemic inflammation
timeFrame: 2 weeks
measure: Systemic inflammation
timeFrame: 2 weeks
measure: Systemic cardiometabolic health
timeFrame: 2 weeks
measure: Systemic lipid profile
timeFrame: 2 weeks
measure: Weight changes
timeFrame: 2 weeks
measure: Handgrip strength changes
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital of Leuven
Study officials:
affiliation: Leuven University Hospitals
name: João Sabino, MD
role: PRINCIPAL_INVESTIGATOR
References: