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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening | Other | D-42 to D-7 |
|
| Lactulose | Other | D0 |
|
| Meal 1 | Other | D14+/-7 |
|
| Meal 2 | Other | D16+/-7 |
|
| Meal 3 | Other | D18+/-7 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screening visit | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exhaled volatile compounds | Selected Ion flow tube mass spectrometry (SIFT-MS) - Area under the curve (calculated on 8 hours following breakfast ingestion) | Throughout the entire study, approximately during 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiota | Illumina sequencing of 16S ribosomal deoxyribonucleic acid (rDNA), quantitative polymerase chain reaction (PCR) | Throughout the entire study, approximately during 24 months |
| Salivary microbiota |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathalie Delzenne, Prof. | Contact | 0032 2 764 73 69 | nathalie.delzenne@uclouvain.be |
| Name | Affiliation | Role |
|---|---|---|
| Nathalie Delzenne, Prof. | Université Catholique de Louvain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Investigation in Clinical Nutrition (CICN), UCLouvain/CICN | Not yet recruiting | Ottignies-Louvain-la-Neuve | Brabant Wallon | 1348 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35561452 | Background | 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. | |
| 33461385 |
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All data will be shared by the partners from the Consortium agreement.
Data will be shared at the end of the study.
At the end of the study
Belonging to the project partner (Consortium agreement)
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| Lactulose test | 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. |
|
| Administration of standardized meals with characterized dietary fiber content | 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. |
|
Illumina sequencing of 16SrDNA, quantitative PCR
| Throughout the entire study, approximately during 24 months |
| Gastrointestinal symptom - discomfort | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 8 hours following breakfast ingestion) | Throughout the entire study, approximately during 24 months |
| Gastrointestinal symptom - nausea | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 8 hours following breakfast ingestion) | Throughout the entire study, approximately during 24 months |
| Gastrointestinal symptom - bloating | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 8 hours following breakfast ingestion) | Throughout the entire study, approximately during 24 months |
| Gastrointestinal symptom - flatulences | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 8 hours following breakfast ingestion) | Throughout the entire study, approximately during 24 months |
| Gastrointestinal symptom - gastrointestinal reflux | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 8 hours following breakfast ingestion) | Throughout the entire study, approximately during 24 months |
| Gastrointestinal symptom - cramps | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 8 hours following breakfast ingestion) | Throughout the entire study, approximately during 24 months |
| Gastrointestinal symptom - rumbling | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 8 hours following breakfast ingestion) | Throughout the entire study, approximately during 24 months |
| Gastrointestinal symptom - burps | 100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) | Throughout the entire study, approximately during 24 months |
| Gut microbiota metabolic capacity | Enzymatic analysis via in-vitro studies, incubation of fecal extracts | Throughout the entire study, approximately during 24 months |
| Exhaled hydrogen (H2) | Lactotest 202 - Area under the curve (calculated on 4 hours following lactulose ingestion) | Throughout the entire study, approximately during 24 months |
| Exhaled methane (CH4) | Lactotest 202 - Area under the curve (calculated on 8 hours following breakfast ingestion) | Throughout the entire study, approximately during 24 months |
| Exhaled carbon dioxide (CO2) | Lactotest 202 - Area under the curve (calculated on 4 hours following lactulose ingestion) | Throughout the entire study, approximately during 24 months |
| Carbohydrates utilization - Carbohydrate active enzymes (CAZymes) | Saliva enzymatic activities | Throughout the entire study, approximately during 24 months |
| Nutrient intake | Food diary (daily log of what the volunteer eats and drinks each day) | Throughout the entire study, approximately during 24 months |
| Dietary habits | Food frequency questionnaire (FFQ) (record the volunteers' usual diet and dietary habits) | Throughout the entire study, approximately during 24 months |
| Well-being | The short form (36) health survey (SF36) (0 = worse physical and mental health functioning, 100 = best physical and mental health functioning) | Throughout the entire study, approximately during 24 months |
| Transit - frequency | Questionnaire on stool frequency (record each defecation time) | Throughout the entire study, approximately during 24 months |
| Transit - type of stool | Bristol stools scale (BSS) (classify the form of feces into 7 categories; type 1 = severe constipation, type 2 = mild constipation, types 3 and 4 = normal, type 5 = lacking fiber, type 6 = mild diarrhea, type 7 = severe diarrhea) | Throughout the entire study, approximately during 24 months |
| Transit - ease of passage | 5-point Likert's scale (1 = very difficult to defecate, 5 = very easy to defecate) | Throughout the entire study, approximately during 24 months |
| Transit - level of emergency | 5-point Likert's scale (1 = very urgent need to defecate, 5 = very nonurgent need to defecate) | Throughout the entire study, approximately during 24 months |
| Transit - empty feeling | 5-point Likert's scale (1 = very nonempty feeling after defecation, 5 = very empty feeling after defecation) | Throughout the entire study, approximately during 24 months |
| Metabolism and Nutrition research group (MNUT), Louvain Drug Research Institute (LDRI), UCLouvain | Recruiting | Woluwe-Saint-Lambert | Brussels Capital | 1200 | Belgium |
|
| Testing rooms of Institute of Neuroscience (IONS), UCLouvain/IONS | Recruiting | Woluwe-Saint-Lambert | Brussels Capital | 1200 | Belgium |
|
| 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. |
| 42174564 | Derived | Lengele L, Autuori M, Bosteels E, Neyrinck AM, Rombaux M, Cani PD, Dormal V, Deldicque L, Bindels LB, Delzenne NM. Link between ultra-processed foods and drinks intake, gut microbiota and inflammation: an exploratory analysis in adult volunteers. Nutr J. 2026 May 22. doi: 10.1186/s12937-026-01340-8. Online ahead of print. |