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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
106
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
Gut microbiota composition
Relative abundance (percent) of bacterial taxa will be assessed by 16S rRNA gene sequencing
Time frame: Month 0 - Month 3
Anthropometry
height (cm)
Time frame: Month 0 - Month 3
Anthropometry
weight (kg)
Time frame: Month 0 - Month 3
Anthropometry
hip circumference and waist circumference (cm)
Time frame: Month 0 - Month 3
Anthropometry
Body mass index (BMI, kg/m2)
Time frame: Month 0 - Month 3
Anthropometry
Body composition by bioimpedance analysis (fat mass, fat free mass, kg)
Time frame: Month 0 - Month 3
Anthropometry
Body composition by CT scan analysis (fat and muscle areas, cm2)
Time frame: Month 0 - Month 3
Blood pressure
systolic and diastolic blood pressures (mm Hg)
Time frame: Month 0 - Month 3
Glucose homeostasis
glycemia (mg/dl) (fasted, after an oral glucose tolerance test)
Time frame: Month 0 - Month 3
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Glucose homeostasis
insulinemia (mU/l) (fasted, after an oral glucose tolerance test)
Time frame: Month 0 - Month 3
Glucose homeostasis
C-peptide (pM)
Time frame: Month 0 - Month 3
Glucose homeostasis
glycated hemoglobin HbA1c (percent)
Time frame: Month 0 - Month 3
Glucose homeostasis
dipeptidyl-peptidase IV activity in the plasma (UI/l)
Time frame: Month 0 - Month 3
Lipid homeostasis
HLD-Cholesterol, triglycerides, total cholesterol, free fatty acids in the plasma (mg/dl)
Time frame: Month 0 - Month 3
Hepatic fibrosis and/or steatosis
hepatic enzymes in the plasma (AST, ALT, gamma-glutamyl transpeptidase, U/l)
Time frame: Month 0 - Month 3
Hepatic fibrosis and/or steatosis
Elasticity by Fibroscan (kPa)
Time frame: Month 0 - Month 3
Hepatic fibrosis and/or steatosis
controlled attenuation parameter (CAP) by Fibroscan (dB/m)
Time frame: Month 0 - Month 3
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.
Time frame: Month 0 - Month 3
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).
Time frame: Month 0 - Month 3
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)
Time frame: Month 0 - Month 3
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)
Time frame: Month 0 - Month 3
Mood and emotional competence
Profile of Emotional Competence (PEC, from 0 to 5, higher score associated with better emotional competence).
Time frame: Month 0 - Month 3
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.
Time frame: Month 0 - Month 3
Dietary intake
one-week recall questionnaire to evaluate the dietary intake (macronutrients, caloric intake)
Time frame: Month 0 - Month 3
Biomarkers of systemic inflammation
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 peptides
Gut peptide (GLP-1, GIP, ghrelin, PP, leptin) multiplex immunoassay (all in pg/ml)
Time frame: Month 0 - Month 3
Metabolomics
metabolomic analysis of biological samples (urine, blood and/or stool)
Time frame: Month 0 - Month 3
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)
Time frame: Month 0 - Month 3