Development of Non-invasive Methods to Study Gut Microbiome - Nutrition - Host Interactions

NCT ID: NCT05949411

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-12-31

Brief Summary

The aim of this study is to develop and validate an adequate protocol of volatolome (volatile metabolites) measurement in breath of human volunteers (18-65 years) to study gut microbiome - nutrition - host interactions in a general healthy population. For this purpose, breath volatile metabolites (BVM) will be analyzed throughout test days in fasting state and after standardized meals using selected ion flow tube mass spectrometry (SIFT-MS). In addition, gut microbial functions linked notably to hydrogen/methane production, carbohydrates utilization (CAZymes), and in the production of other volatile metabolites of interest (i.e. indole, fatty acid derivatives, ...) will be unraveled through microbiome sequencing data analysis (in silico), metabolomic analyses and measurement of enzymatic activities from saliva, urine and/or fecal samples.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Screening

D-42 to D-7

Group Type: OTHER

Screening visit

Intervention Type: OTHER

Subjects will be invited to perform the screening visit to sign the informed consent and then to ensure that they are able to participate in this study.

Lactulose

D0

Group Type: OTHER

Lactulose test

Intervention Type: OTHER

Fasted subjects (at least 10 hours) will receive on oral load of 10 g of lactulose. Then, exhaled H2 will be measured every 30 minutes during 4 hours.

Meal 1

D14+/-7

Group Type: OTHER

Administration of standardized meals with characterized dietary fiber content

Intervention Type: OTHER

Subjects will receive standardized breakfasts and lunches characterized in terms of dietary fiber content. Urine, saliva, feces samples will be collected. Breath test and gastrointestinal symptoms will be followed during maximum 8h. Subjects will also complete SF36 questionnaire, food diary and stool/transit questionnaire.

Meal 2

D16+/-7

Group Type: OTHER

Administration of standardized meals with characterized dietary fiber content

Intervention Type: OTHER

Subjects will receive standardized breakfasts and lunches characterized in terms of dietary fiber content. Urine, saliva, feces samples will be collected. Breath test and gastrointestinal symptoms will be followed during maximum 8h. Subjects will also complete SF36 questionnaire, food diary and stool/transit questionnaire.

Meal 3

D18+/-7

Group Type: OTHER

Administration of standardized meals with characterized dietary fiber content

Intervention Type: OTHER

Subjects will receive standardized breakfasts and lunches characterized in terms of dietary fiber content. Urine, saliva, feces samples will be collected. Breath test and gastrointestinal symptoms will be followed during maximum 8h. Subjects will also complete SF36 questionnaire, food diary and stool/transit questionnaire.

Interventions

Screening visit

Subjects will be invited to perform the screening visit to sign the informed consent and then to ensure that they are able to participate in this study.

Intervention Type: OTHER

Lactulose test

Fasted subjects (at least 10 hours) will receive on oral load of 10 g of lactulose. Then, exhaled H2 will be measured every 30 minutes during 4 hours.

Intervention Type: OTHER

Administration of standardized meals with characterized dietary fiber content

Subjects will receive standardized breakfasts and lunches characterized in terms of dietary fiber content. Urine, saliva, feces samples will be collected. Breath test and gastrointestinal symptoms will be followed during maximum 8h. Subjects will also complete SF36 questionnaire, food diary and stool/transit questionnaire.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Woman or man, aged of 18 to 65 years;
• Body mass index (BMI) between 18 and 30 kg/m2;
• Non-smoker;
• Provision of signed and dated informed consent form;
• Stated willingness to comply with all study procedures and availability for the duration of the study;
• Speaking French.

Exclusion Criteria

• Subject with severe systemic disease (renal or hepatic failure, cancer, pancreatic cancer, chronic pancreatitis, asthma …)
• Subject with a history or current chronic/severe gastrointestinal disorder such as duodenal ulcer, chronic colitis, or chronic inflammatory disease of the digestive tract disease (Crohn's disease, ulcerative colitis), celiac disease or irritable bowel syndrome;
• Subjects with a history of digestive tract surgery (except appendectomy);
• Subject who had surgery within the two months prior to the study
• Subjects with psychiatric problems and/or using antipsychotics
• Current or recent (< 4 weeks) intake of antibiotics, fiber supplement, and/or any products modulating gut transit (laxative, anti-diarrheal, ...) or gut microbiota composition; these products will also be avoided for the duration of the study;
• Chronic intake of drugs, except contraceptive drug;
• Subject following a low-calorie diet and followed by a doctor or dietician in progress or recently (< 6 weeks);
• Women of childbearing age who are pregnant or breastfeeding or who wish to become pregnant within the next 6 weeks or who are not using an adequate method of contraception (e.g. oral contraception, intrauterine device (IUD), abstinence, ...);
• Subjects who drink more than 3 glasses of alcohol per day (> 30 g of alcohol per day);
• Subjects having participated to another clinical trial two weeks before the screening test visit;
• Subjects who practice an intense sport activity (more than 10 hours per week of intense activity);
• Language barrier, mental or legal incapacity, unwillingness or inability to understand or not being able to participate to the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathalie Delzenne, Prof.

Role: PRINCIPAL_INVESTIGATOR

Université Catholique de Louvain

Locations

Center of Investigation in Clinical Nutrition (CICN), UCLouvain/CICN

Ottignies-Louvain-la-Neuve, Brabant Wallon, Belgium

Site Status: NOT_YET_RECRUITING

Metabolism and Nutrition research group (MNUT), Louvain Drug Research Institute (LDRI), UCLouvain

Woluwe-Saint-Lambert, Brussels Capital, Belgium

Site Status: RECRUITING

Testing rooms of Institute of Neuroscience (IONS), UCLouvain/IONS

Woluwe-Saint-Lambert, Brussels Capital, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Nathalie Delzenne, Prof.

Role: CONTACT

nathalie.delzenne@uclouvain.be

0032 2 764 73 69

Facility Contacts

Louise Deldicque, Prof.

Role: primary

Nathalie Delzenne, Prof.

Role: primary

Louise Deldicque, Prof.

Role: primary

References

Neyrinck AM, Rodriguez J, Zhang Z, Nazare JA, Bindels LB, Cani PD, Maquet V, Laville M, Bischoff SC, Walter J, Delzenne NM. Breath volatile metabolome reveals the impact of dietary fibres on the gut microbiota: Proof of concept in healthy volunteers. EBioMedicine. 2022 Jun;80:104051. doi: 10.1016/j.ebiom.2022.104051. Epub 2022 May 10.

Reference Type: BACKGROUND

PMID: 35561452 (View on PubMed)

Neyrinck AM, Rodriguez J, Zhang Z, Seethaler B, Mailleux F, Vercammen J, Bindels LB, Cani PD, Nazare JA, Maquet V, Laville M, Bischoff SC, Walter J, Delzenne NM. Noninvasive monitoring of fibre fermentation in healthy volunteers by analyzing breath volatile metabolites: lessons from the FiberTAG intervention study. Gut Microbes. 2021 Jan-Dec;13(1):1-16. doi: 10.1080/19490976.2020.1862028.

Reference Type: BACKGROUND

PMID: 33461385 (View on PubMed)

Other Identifiers

MICROBOOST

Identifier Type: -

Identifier Source: org_study_id