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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Behavioral: High AGEs diet; Behavioral: Low AGEs diet

• Registration Number: NCT06547190
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study Start: 2022-02-01
• Primary Completion: 2022-05-03
• Study Completion: 2022-07-30
• Study First Submitted: 2024-07-31
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-07
• Last Update Submitted: 2024-08-07
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HL	Low AGEs diet	High-to-Low AGEs diet
LH	Low AGEs diet	Low-to-High AGEs diet
HL	High AGEs diet	High-to-Low AGEs diet
LH	High AGEs diet	Low-to-High AGEs diet

Primary Outcome Measures

Name	Time	Method
Gut microbial composition	2 weeks	Measurement of the composition of the gut microbiota using 16s rRNA sequencing of stool samples.
Intestinal inflammation	2 weeks	Measurement of faecal calprotectin through stool samples (in mg/kg)
Intestinal transcellular permeability	2 weeks	Measurement of transcellular intestinal permeability using lipopolysaccharide binding protein in blood samples
Systemic inflammation	2 weeks	Every serum CRP in blood samples (in mg/l)
Systemic lipid profile	2 weeks	Total, LDL- and HDL-cholesterol values in blood samples (in mg/dl)
Weight changes	2 weeks	weight (in kg)
Gut microbial metabolism	2 weeks	Measurement of short chain fatty acids including acetic acid, propionic acid and butyric acid through stool samples (in mg/100g stool)
Intestinal paracellular permeability	2 weeks	Measurement of paracellular intestinal permeability using the lacultulose mannitol test using urine samples
Systemic cardiometabolic health	2 weeks	serum cardiometabolic parameters through OLINK cardiometabolic panel (measurement of 92 proteins in blood)
Handgrip strength changes	2 weeks	Handgrip strength (in kg)

Trial Locations

Locations (1)

University Hospital of Leuven; 🇧🇪 Leuven, Belgium