NCT03852069

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

2.3 years

First QC Date

February 21, 2019

Last Update Submit

December 18, 2020

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Gut microbiota composition

    Relative abundance (percent) of bacterial taxa will be assessed by 16S rRNA gene sequencing

    Month 0 - Month 3

Secondary Outcomes (27)

  • Anthropometry

    Month 0 - Month 3

  • Anthropometry

    Month 0 - Month 3

  • Anthropometry

    Month 0 - Month 3

  • Anthropometry

    Month 0 - Month 3

  • Anthropometry

    Month 0 - Month 3

  • +22 more secondary outcomes

Other Outcomes (4)

  • Fecal microbial-derived metabolites

    Month 0 - Month 3

  • Biomarkers of gut integrity and inflammation

    Month 0 - Month 3

  • Biomarkers of gut integrity and inflammation

    Month 0 - Month 3

  • +1 more other outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

16 g maltodextrin/day + recipes based on vegetables poor in inulin-type fructans

Dietary Supplement: Placebo

Inulin

EXPERIMENTAL

16 g inulin/day + recipes based on vegetables rich in inulin-type fructans

Dietary Supplement: Inulin

Interventions

InulinDIETARY_SUPPLEMENT

Patient receive inulin as dietary supplement (16g/d) in combination with dietary advice to restrict caloric intake and to enhance the consumption of inulin-rich vegetables

Inulin
PlaceboDIETARY_SUPPLEMENT

Patient receive maltodextrin as dietary supplement (16g/d) in combination with dietary advice to restrict caloric intake and to enhance the consumption of vegetables poor in inulin

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 32340903RESULT

  • 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.

    PMID: 33023763RESULT

  • Moens de Hase E, Neyrinck AM, Rodriguez J, Cnop M, Paquot N, Thissen JP, Xu Y, Beloqui A, Bindels LB, Delzenne NM, Van Hul M, Cani PD. Impact of metformin and Dysosmobacter welbionis on diet-induced obesity and diabetes: from clinical observation to preclinical intervention. Diabetologia. 2024 Feb;67(2):333-345. doi: 10.1007/s00125-023-06032-0. Epub 2023 Oct 28.

    PMID: 37897566DERIVED

  • 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.

    PMID: 35351144DERIVED

  • 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.

    PMID: 35011021DERIVED

  • 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.

    PMID: 34355155DERIVED

  • 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.

    PMID: 33544206DERIVED

  • 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.

    PMID: 33515740DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Inulin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharides

Study Officials

  • Jean-Paul Thissen, Pr.

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2019

First Posted

February 22, 2019

Study Start

January 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

December 22, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share