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Completed

NCT Number: NCT06547190

Study on Treating by Eating: Role of AGEs on Mucosal Barrier and Microbiome.

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Leuven

Leuven, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High AGEs diet

Behavioral

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 diet

Behavioral

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.

Primary outcomes

  1. Intestinal inflammation

    Time frame: 2 weeks

    Measurement of faecal calprotectin through stool samples (in mg/kg)

  2. 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)

  3. Gut microbial composition

    Time frame: 2 weeks

    Measurement of the composition of the gut microbiota using 16s rRNA sequencing of stool samples.

  4. Intestinal transcellular permeability

    Time frame: 2 weeks

    Measurement of transcellular intestinal permeability using lipopolysaccharide binding protein in blood samples

  5. Intestinal paracellular permeability

    Time frame: 2 weeks

    Measurement of paracellular intestinal permeability using the lacultulose mannitol test using urine samples

  6. Systemic inflammation

    Time frame: 2 weeks

    serum inflammation through OLINK inflammatory panel (measurement of 92 proteins in blood)

  7. Systemic inflammation

    Time frame: 2 weeks

    Every serum CRP in blood samples (in mg/l)

  8. Systemic cardiometabolic health

    Time frame: 2 weeks

    serum cardiometabolic parameters through OLINK cardiometabolic panel (measurement of 92 proteins in blood)

  9. Systemic lipid profile

    Time frame: 2 weeks

    Total, LDL- and HDL-cholesterol values in blood samples (in mg/dl)

  10. Weight changes

    Time frame: 2 weeks

    weight (in kg)

  11. Handgrip strength changes

    Time frame: 2 weeks

    Handgrip strength (in kg)

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Flemish institute of biotechnology (VIB)

Registry information

Acronym: STEAMM

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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