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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Behavioral: High AGEs diet; Behavioral: Low AGEs diet

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • University Hospital of Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HL; High-to-Low AGEs diet	Behavioral: High AGEs diet; 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.; Behavioral: Low AGEs diet; 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.
Experimental: LH; Low-to-High AGEs diet	Behavioral: High AGEs diet; 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.; Behavioral: Low AGEs diet; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: Vlaams Instituut voor Biotechnologie (VIB)
• Investigators: Principal Investigator: João Sabino, MD, Leuven University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): May 3, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Advanced Glycation End products; Cooking Methods; Culinary Techniques
• Other Study ID Numbers: S65600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: To be discussed upon request.
• IPD Sharing Time Frame: Upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No