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ObesityFood4GutNCT03852069

Inulin-type Fructans-rich Vegetables, Obesity, Gut Microbiota

A study testing Inulin in people with Obesity, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity
What is being tested?
Inulin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
106 participants
Where
No sites listed yet
Study dates
Jan 2016to May 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

About this study

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

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.

Conditions
Obesity
Being tested
Inulin, Placebo
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • 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

Study groups in NCT03852069
Study groupRoleWhat they receive
PlaceboPlacebo comparator16 g maltodextrin/day + recipes based on vegetables poor in inulin-type fructans
Receives: Dietary Supplement: Placebo
InulinExperimental16 g inulin/day + recipes based on vegetables rich in inulin-type fructans
Receives: Dietary Supplement: Inulin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gut microbiota composition

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

    Measured: Month 0 - Month 3

Secondary outcomes (27)

  1. Anthropometry

    height (cm)

    Measured: Month 0 - Month 3

  2. Anthropometry

    weight (kg)

    Measured: Month 0 - Month 3

  3. Anthropometry

    hip circumference and waist circumference (cm)

    Measured: Month 0 - Month 3

  4. Anthropometry

    Body mass index (BMI, kg/m2)

    Measured: Month 0 - Month 3

  5. Anthropometry

    Body composition by bioimpedance analysis (fat mass, fat free mass, kg)

    Measured: Month 0 - Month 3

  6. Anthropometry

    Body composition by CT scan analysis (fat and muscle areas, cm2)

    Measured: Month 0 - Month 3

  7. Blood pressure

    systolic and diastolic blood pressures (mm Hg)

    Measured: Month 0 - Month 3

  8. Glucose homeostasis

    glycemia (mg/dl) (fasted, after an oral glucose tolerance test)

    Measured: Month 0 - Month 3

  9. Glucose homeostasis

    insulinemia (mU/l) (fasted, after an oral glucose tolerance test)

    Measured: Month 0 - Month 3

  10. Glucose homeostasis

    C-peptide (pM)

    Measured: Month 0 - Month 3

  11. Glucose homeostasis

    glycated hemoglobin HbA1c (percent)

    Measured: Month 0 - Month 3

  12. Glucose homeostasis

    dipeptidyl-peptidase IV activity in the plasma (UI/l)

    Measured: Month 0 - Month 3

  13. Lipid homeostasis

    HLD-Cholesterol, triglycerides, total cholesterol, free fatty acids in the plasma (mg/dl)

    Measured: Month 0 - Month 3

  14. Hepatic fibrosis and/or steatosis

    hepatic enzymes in the plasma (AST, ALT, gamma-glutamyl transpeptidase, U/l)

    Measured: Month 0 - Month 3

  15. Hepatic fibrosis and/or steatosis

    Elasticity by Fibroscan (kPa)

    Measured: Month 0 - Month 3

  16. Hepatic fibrosis and/or steatosis

    controlled attenuation parameter (CAP) by Fibroscan (dB/m)

    Measured: Month 0 - Month 3

  17. Eating behavior

    Questionnaire for Eating Disorders Diagnosis (Q-EDD). The Q-EDD is a 50-items questionnaire based on Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV allowing the psychologist to diagnose eating disorders (anorexia nervosa, bulimia, binge eating), there is no quantitative result.

    Measured: Month 0 - Month 3

  18. Eating behavior

    Dutch Eating Behaviour Questionnaire (DEBQ).The DEBQ is a 33-items questionnaire assessing 3 distinct behaviour: emotional eating (13 items), external eating (10 items) and restrained eating (10 items). Each item is rated on a 5-point scale. A high score is observed when individual tended to eat more when submitted to emotional and external stimuli (for emotional and external eating subscales) or when he displayed elevated cognitive control on its eating behaviour (for the restrained eating subscale).

    Measured: Month 0 - Month 3

  19. Mood and emotional competence

    Positive and Negative Affect Schedule (PANAS, two subscale - positive and negative - from 10 to 50, higher score associated with higher positive and negative emotion respectively)

    Measured: Month 0 - Month 3

  20. Mood and emotional competence

    Scale of Positive and Negative Experience (SPANE, two subscale - positive and negative - from 6 to 30, higher score associated with higher positive and negative emotion respectively)

    Measured: Month 0 - Month 3

  21. Mood and emotional competence

    Profile of Emotional Competence (PEC, from 0 to 5, higher score associated with better emotional competence).

    Measured: Month 0 - Month 3

  22. Cognition

    computer-based tests of the flexibility, the working memory and the inhibition of participants. The measurements will be the time to complete the task on the computer as well as the number of errors.

    Measured: Month 0 - Month 3

  23. Dietary intake

    one-week recall questionnaire to evaluate the dietary intake (macronutrients, caloric intake)

    Measured: Month 0 - Month 3

  24. Biomarkers of systemic inflammation

    Cytokines levels (Il-1β; IL-8; IL-12p70; IL-17a; MCP1; TNFα; IFNγ) by multiplex immunoassay (all in pg/ml)

    Measured: Month 0 - Month 3

  25. Gut peptides

    Gut peptide (GLP-1, GIP, ghrelin, PP, leptin) multiplex immunoassay (all in pg/ml)

    Measured: Month 0 - Month 3

  26. Metabolomics

    metabolomic analysis of biological samples (urine, blood and/or stool)

    Measured: Month 0 - Month 3

  27. Physical activity

    IPAQ questionnaire (The IPAQ long form asks details about the specific types of activities undertaken within the four main domains (leisure time PA, domestic and gardening (yard) activities, work-related PA and transport-related PA). Computation of the total scores for the long form requires summation of the duration (in minutes) and frequency (days) for all the types of activities in all domains. Results allowed us to classify different levels of PA proposed by the questionnaire (total, low-moderate or high-intensity physical activities)

    Measured: Month 0 - Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2019
  2. Study startJan 2016
  3. Primary completionMay 2018
  4. Study completionMay 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03852069
Sponsor's protocol ID
B403201422056
Acronym
Food4Gut
Status last verified
Dec 2020
First submitted
21 Feb 2019
Last updated
22 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32340903

  • 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.

    PubMed 33023763

  • 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.

    PubMed 37897566

  • 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.

    PubMed 35351144

  • 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.

    PubMed 35011021

  • 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.

    PubMed 34355155

  • 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.

    PubMed 33544206

  • 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.

    PubMed 33515740

Questions about this trial

What is this clinical trial studying?

A study testing Inulin in people with Obesity, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gut microbiota composition (time frame: Month 0 - Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03852069, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.

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