Inulin
Dietary SupplementPatient 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
NCT Number: NCT03852069
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: Month 0 - Month 3
Relative abundance (percent) of bacterial taxa will be assessed by 16S rRNA gene sequencing
Time frame: Month 0 - Month 3
height (cm)
Time frame: Month 0 - Month 3
weight (kg)
Time frame: Month 0 - Month 3
hip circumference and waist circumference (cm)
Time frame: Month 0 - Month 3
Body mass index (BMI, kg/m2)
Time frame: Month 0 - Month 3
Body composition by bioimpedance analysis (fat mass, fat free mass, kg)
Time frame: Month 0 - Month 3
Body composition by CT scan analysis (fat and muscle areas, cm2)
Time frame: Month 0 - Month 3
systolic and diastolic blood pressures (mm Hg)
Time frame: Month 0 - Month 3
glycemia (mg/dl) (fasted, after an oral glucose tolerance test)
Time frame: Month 0 - Month 3
insulinemia (mU/l) (fasted, after an oral glucose tolerance test)
Time frame: Month 0 - Month 3
C-peptide (pM)
Time frame: Month 0 - Month 3
glycated hemoglobin HbA1c (percent)
Time frame: Month 0 - Month 3
dipeptidyl-peptidase IV activity in the plasma (UI/l)
Time frame: Month 0 - Month 3
HLD-Cholesterol, triglycerides, total cholesterol, free fatty acids in the plasma (mg/dl)
Time frame: Month 0 - Month 3
hepatic enzymes in the plasma (AST, ALT, gamma-glutamyl transpeptidase, U/l)
Time frame: Month 0 - Month 3
Elasticity by Fibroscan (kPa)
Time frame: Month 0 - Month 3
controlled attenuation parameter (CAP) by Fibroscan (dB/m)
Time frame: Month 0 - Month 3
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.
Time frame: Month 0 - Month 3
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).
Time frame: Month 0 - Month 3
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)
Time frame: Month 0 - Month 3
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)
Time frame: Month 0 - Month 3
Profile of Emotional Competence (PEC, from 0 to 5, higher score associated with better emotional competence).
Time frame: Month 0 - Month 3
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.
Time frame: Month 0 - Month 3
one-week recall questionnaire to evaluate the dietary intake (macronutrients, caloric intake)
Time frame: Month 0 - Month 3
Cytokines levels (Il-1β; IL-8; IL-12p70; IL-17a; MCP1; TNFα; IFNγ) by multiplex immunoassay (all in pg/ml)
Time frame: Month 0 - Month 3
Gut peptide (GLP-1, GIP, ghrelin, PP, leptin) multiplex immunoassay (all in pg/ml)
Time frame: Month 0 - Month 3
metabolomic analysis of biological samples (urine, blood and/or stool)
Time frame: Month 0 - Month 3
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)
Time frame: Month 0 - Month 3
Long and short chain fatty acid and bile acid profiles (ng/mg feces or percent) considered as exploratory analyses not initially scheduled in the study but performed in the context of the FiberTAG project. Before inclusion of the study, all participants provided written informed consent stipulating that any research outside the context performed in the future could only be conducted after approval by an ethics committee. We obtained agreement from the ethical committee of Saint-Luc for those exploratory analyses
Time frame: Month 0 - Month 3
Fecal zonulin (ng/mg feces) considered as exploratory analyses not initially scheduled in the study but performed in the context of the FiberTAG project. Before inclusion of the study, all participants provided written informed consent stipulating that any research outside the context performed in the future could only be conducted after approval by an ethics committee. We obtained agreement from the ethical committee of Saint-Luc for those exploratory analyses
Time frame: Month 0 - Month 3
fecal albumin (ng/mg feces) considered as exploratory analyses not initially scheduled in the study but performed in the context of the FiberTAG project. Before inclusion of the study, all participants provided written informed consent stipulating that any research outside the context performed in the future could only be conducted after approval by an ethics committee. We obtained agreement from the ethical committee of Saint-Luc for those exploratory analyses
Time frame: Month 0 - Month 3
fecal calprotectin (ng/mg feces) considered as exploratory analyses not initially scheduled in the study but performed in the context of the FiberTAG project. Before inclusion of the study, all participants provided written informed consent stipulating that any research outside the context performed in the future could only be conducted after approval by an ethics committee. We obtained agreement from the ethical committee of Saint-Luc for those exploratory analyses
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Other
Impact of a Diet Rich in Inulin-type Fructans Combined With Inulin Supplementation on Gut Microbiota Composition and Metabolic Parameters in Obese Patients
Acronym: Food4Gut
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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