Clinical trial NCT03852069: Inulin-type Fructans-rich Vegetables, Obesity, Gut Microbiota
Official title: Impact of a Diet Rich in Inulin-type Fructans Combined With Inulin Supplementation on Gut Microbiota Composition and Metabolic Parameters in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to evaluate the effect of a diet based on ITF-rich vegetables in combination with purified ITF supplementation on weight management, metabolic alteration and gut microbiota composition. Obese patients were treated for 3 months and several parameters were measured before and after the study period.


Eligibility criteria: Inclusion Criteria:

* Body mass index \> 30 kg/m²
* Caucasian
* Presence of at least one of the following comorbidity : prediabetes, diabetes, dyslipidemia, hypertension, steatosis.

Exclusion Criteria:

* Psychiatric problems or use of antipsychotic
* Consumption of antibiotics, pro/prebiotics, fibre dietary supplement, or any molecules that modifies the intestinal transit (\<6 weeks)
* Pregnancy in progress or planified within 6 months
* Specific dietary practise (vegetarian, vegan,...)
* Specific dietary treatment (\<6 weeks) (e.g. high protein diet)
* Type 1 diabetes
* Excessive alcohol consumption (\>3 glasses/day)
* Inconclusive acceptability test (regarding the protocol of the intervention and the vegetables used in the protocol)

Primary outcomes:
measure: Gut microbiota composition
timeFrame: Month 0 - Month 3
Secondary outcomes:
measure: Anthropometry
timeFrame: Month 0 - Month 3
measure: Anthropometry
timeFrame: Month 0 - Month 3
measure: Anthropometry
timeFrame: Month 0 - Month 3
measure: Anthropometry
timeFrame: Month 0 - Month 3
measure: Anthropometry
timeFrame: Month 0 - Month 3
measure: Anthropometry
timeFrame: Month 0 - Month 3
measure: Blood pressure
timeFrame: Month 0 - Month 3
measure: Glucose homeostasis
timeFrame: Month 0 - Month 3
measure: Glucose homeostasis
timeFrame: Month 0 - Month 3
measure: Glucose homeostasis
timeFrame: Month 0 - Month 3
measure: Glucose homeostasis
timeFrame: Month 0 - Month 3
measure: Glucose homeostasis
timeFrame: Month 0 - Month 3
measure: Lipid homeostasis
timeFrame: Month 0 - Month 3
measure: Hepatic fibrosis and/or steatosis
timeFrame: Month 0 - Month 3
measure: Hepatic fibrosis and/or steatosis
timeFrame: Month 0 - Month 3
measure: Hepatic fibrosis and/or steatosis
timeFrame: Month 0 - Month 3
measure: Eating behavior
timeFrame: Month 0 - Month 3
measure: Eating behavior
timeFrame: Month 0 - Month 3
measure: Mood and emotional competence
timeFrame: Month 0 - Month 3
measure: Mood and emotional competence
timeFrame: Month 0 - Month 3
measure: Mood and emotional competence
timeFrame: Month 0 - Month 3
measure: Cognition
timeFrame: Month 0 - Month 3
measure: Dietary intake
timeFrame: Month 0 - Month 3
measure: Biomarkers of systemic inflammation
timeFrame: Month 0 - Month 3
measure: Gut peptides
timeFrame: Month 0 - Month 3
measure: Metabolomics
timeFrame: Month 0 - Month 3
measure: Physical activity
timeFrame: Month 0 - Month 3
Other outcomes:
measure: Fecal microbial-derived metabolites
timeFrame: Month 0 - Month 3
measure: Biomarkers of gut integrity and inflammation
timeFrame: Month 0 - Month 3
measure: Biomarkers of gut integrity and inflammation
timeFrame: Month 0 - Month 3
measure: Biomarkers of gut integrity and inflammation
timeFrame: Month 0 - Month 3
Locations:
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Jean-Paul Thissen, Pr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hiel S, Gianfrancesco MA, Rodriguez J, Portheault D, Leyrolle Q, Bindels LB, Gomes da Silveira Cauduro C, Mulders MDGH, Zamariola G, Azzi AS, Kalala G, Pachikian BD, Amadieu C, Neyrinck AM, Loumaye A, Cani PD, Lanthier N, Trefois P, Klein O, Luminet O, Bindelle J, Paquot N, Cnop M, Thissen JP, Delzenne NM. Link between gut microbiota and health outcomes in inulin -treated obese patients: Lessons from the Food4Gut multicenter randomized placebo-controlled trial. Clin Nutr. 2020 Dec;39(12):3618-3628. doi: 10.1016/j.clnu.2020.04.005. Epub 2020 Apr 13.
citation: Leyrolle Q, Cserjesi R, Mulders MDGH, Zamariola G, Hiel S, Gianfrancesco MA, Rodriguez J, Portheault D, Amadieu C, Leclercq S, Bindels LB, Neyrinck AM, Cani PD, Karkkainen O, Hanhineva K, Lanthier N, Trefois P, Paquot N, Cnop M, Thissen JP, Klein O, Luminet O, Delzenne NM. Specific gut microbial, biological, and psychiatric profiling related to binge eating disorders: A cross-sectional study in obese patients. Clin Nutr. 2021 Apr;40(4):2035-2044. doi: 10.1016/j.clnu.2020.09.025. Epub 2020 Sep 28.
citation: Rodriguez J, Neyrinck AM, Van Kerckhoven M, Gianfrancesco MA, Renguet E, Bertrand L, Cani PD, Lanthier N, Cnop M, Paquot N, Thissen JP, Bindels LB, Delzenne NM. Physical activity enhances the improvement of body mass index and metabolism by inulin: a multicenter randomized placebo-controlled trial performed in obese individuals. BMC Med. 2022 Mar 30;20(1):110. doi: 10.1186/s12916-022-02299-z.
citation: Leyrolle Q, Cserjesi R, Demeure R, Neyrinck AM, Amadieu C, Rodriguez J, Karkkainen O, Hanhineva K, Paquot N, Cnop M, Cani PD, Thissen JP, Bindels LB, Klein O, Luminet O, Delzenne NM. Microbiota and Metabolite Profiling as Markers of Mood Disorders: A Cross-Sectional Study in Obese Patients. Nutrients. 2021 Dec 29;14(1):147. doi: 10.3390/nu14010147.
citation: Nachit M, Lanthier N, Rodriguez J, Neyrinck AM, Cani PD, Bindels LB, Hiel S, Pachikian BD, Trefois P, Thissen JP, Delzenne NM. A dynamic association between myosteatosis and liver stiffness: Results from a prospective interventional study in obese patients. JHEP Rep. 2021 Jun 15;3(4):100323. doi: 10.1016/j.jhepr.2021.100323. eCollection 2021 Aug.
citation: Neyrinck AM, Rodriguez J, Zhang Z, Seethaler B, Sanchez CR, Roumain M, Hiel S, Bindels LB, Cani PD, Paquot N, Cnop M, Nazare JA, Laville M, Muccioli GG, Bischoff SC, Walter J, Thissen JP, Delzenne NM. Prebiotic dietary fibre intervention improves fecal markers related to inflammation in obese patients: results from the Food4Gut randomized placebo-controlled trial. Eur J Nutr. 2021 Sep;60(6):3159-3170. doi: 10.1007/s00394-021-02484-5. Epub 2021 Feb 5.
citation: Leyrolle Q, Cserjesi R, D G H Mulders M, Zamariola G, Hiel S, Gianfrancesco MA, Portheault D, Amadieu C, Bindels LB, Leclercq S, Rodriguez J, Neyrinck AM, Cani PD, Lanthier N, Trefois P, Bindelle J, Paquot N, Cnop M, Thissen JP, Klein O, Luminet O, Delzenne NM. Prebiotic effect on mood in obese patients is determined by the initial gut microbiota composition: A randomized, controlled trial. Brain Behav Immun. 2021 May;94:289-298. doi: 10.1016/j.bbi.2021.01.014. Epub 2021 Jan 28.