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

NCT06547190 | Completed

• 1 other identifier: S65600
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Advanced Glycation End products; Cooking Methods; Culinary Techniques

Outcome Measures

Primary Outcomes (11)

• Intestinal inflammation

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

  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)

  2 weeks

• Gut microbial composition

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

  2 weeks

• Intestinal transcellular permeability

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

  2 weeks

• Intestinal paracellular permeability

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

  2 weeks

• Systemic inflammation

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

  2 weeks

• Systemic inflammation

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

  2 weeks

• Systemic cardiometabolic health

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

  2 weeks

• Systemic lipid profile

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

  2 weeks

• Weight changes

  weight (in kg)

  2 weeks

• Handgrip strength changes

  Handgrip strength (in kg)

  2 weeks

Study Arms (2)

HL

EXPERIMENTAL

High-to-Low AGEs diet

Behavioral: High AGEs diet; Behavioral: Low AGEs diet

LH

EXPERIMENTAL

Low-to-High AGEs diet

Behavioral: High AGEs diet; Behavioral: Low AGEs diet

Interventions

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.

HL; LH

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.

HL; LH

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Vlaams Instituut voor Biotechnologie (VIB): collaborator

Study Sites (1)

University Hospital of Leuven

Leuven, Belgium

Location

Related Publications (1)

• 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.

  PMID: 40280130 DERIVED

Study Officials

• João Sabino, MD

  Leuven University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. João Sabino

Model Details: Randomized Cross-over Trial

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 9, 2024
• Study Start: February 1, 2022
• Primary Completion: May 3, 2022
• Study Completion: July 30, 2022
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Upon request

Locations

BE (1)