- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02024425
Functional Bioactive Supplement Effect in Lost Weight Treatment (ALIBIRDII)
A Randomized, Double-blind Trial to Evaluate the Effect of a Functional Bioactive Supplement Associated With a Hypocaloric Equilibrated Diet to Treatment of Obese and Overweight Individuals
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
A randomized, parallel, double-blind, controlled was performed to evaluate the therapeutic effect of a functional bioactive supplement associated with a hypocaloric equilibrated diet to treatment of obesity and overweight.
Women aged between 18 and 65 years with obesity and overweight diagnosis (IMC >25<35 kg/m2) were included in the study. The clinical trial will be performed in the Clinical Nutrition Department of La Paz University Hospital, in Madrid. All of the volunteers will receive a dietetic treatment with 1500 Kcal/day and physical activity recommendations during the study.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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Madrid, Espagne, 28061
- Hospital Universitario La Paz
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Women from 45 to 75 years old;
- Overweight (IMC ≥25<30 Kg/m2) or obese (IMC ≥30<35 Kg/m2) volunteers
- Signed informed consent.
Exclusion Criteria:
- Subjects with drug consumption (lipid-lowering, oral hypoglycemic agents and / or hypertensive) in less than one month period;
- Subjects with Diabetes Mellitus insulin dependent;
- Individuals that stop smoking in the next 12 weeks (during the study);
- Subjects with increased alcohol consumption (> 1 glass of vine);
- Subjects that consume drugs, vitamins, minerals, prebiotics or/and probiotics that interfere with the body's response to the extracts in the 2 weeks before to baseline;
- Subjects with drugs consumption special diet due to disease as celiac disease, chronic renal failure, etc;
- Subjects with disorders associated with eating behaviour;
- Subjects with drugs or supplements consumption to weight lost;
- Subjects with physical problems complying with the recommendations of physical activity and diet indicated;
- Subjects who refuse to perform the indicated dietary changes throughout the study;
- Subjects with diseases that could be involucrate in weight lost (not controlled hypothyroidism, serious psychiatric illness, etc.);
- Subjects with mental disease or low cognitive function;
- Subjects with severe diseases (hepatic, kidney, cancer…);
- Pregnant women or lactating;
- Subjects with physical problems complying with the recommendations of physical activity.
- Subjects with intensive physical activity;
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Functional bioactive supplement
The functional bioactive supplement is composed of antioxidant extracted from rosemary, oligosaccharides derived from lactulose and bioactive peptides.
It will be used for obese and overweight treatment
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1,25g of antioxidant extracted from rosemary, 18g of oligosaccharides derived from lactulosa and 1,25g of bioactive peptides
Autres noms:
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Comparateur placebo: Maltodextrin and saccharose
The control supplement is composed of maltodextrin and saccharose .
It has no effect for obese and overweight treatment
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes in body composition
Délai: 12 weeks
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Clinical response - changes in body composition: weight, waist circumference and Absorptiometry, Dual X-Ray.The primary outcome result measurement was the lost weight, changes in body composition
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12 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Life style and health status: Life style and physical activity questionnaire
Délai: Week 0 and Week 12
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Week 0 and Week 12
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Genetic analysis
Délai: Week 0 and Week 12
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Week 0 and Week 12
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Metabolomic analyses
Délai: Week 0 and Week 12
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Week 0 and Week 12
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Endothelial function markers
Délai: Week 0 y Week 12
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Endothelial function markers: eNOS, VCAM-1, PAI1 and blood pressure
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Week 0 y Week 12
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Satiety hormones
Délai: Week 0 y Week 12
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Satiety hormones: ghrelin, GLP-1; Leptin; adiponectin and NPY
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Week 0 y Week 12
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Inflammatory markers
Délai: Week 0 and Week 12
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Inflammatory markers: TNF-α, IL-6, PCR and fibrinogen
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Week 0 and Week 12
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Glucose Metabolism
Délai: Week 0 and Week 12
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Glucose Metabolism: glucose, basal insulin, HbA1c (in diabetic patients), HOMA index (glycemic insulin sensitivity index was calculated using the formula: HOMA-IR = fasting glucose (mmol/l)/fasting immunoreactive insulin (mU/ml)/22•5)
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Week 0 and Week 12
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Lipid profile: Cholesterol
Délai: Week 0 and Week 12
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Lipid profile: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides
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Week 0 and Week 12
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Oxidative Stress Parameters
Délai: Week 0 and Week 12
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Oxidative Stress Parameters: plasma antioxidant capacity (FRAP, ferric reducing antioxidant power) and lipidic peroxidation (TBARS, thiobarbituric acid reactive substances assay), oxidized LDL, PON1, F2-isoprostanes
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Week 0 and Week 12
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Adverse effects
Délai: 0 , 3, 6, 9 and 12 weeks
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Adverse effects: transaminases and creatinine
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0 , 3, 6, 9 and 12 weeks
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Appetite and satiety
Délai: 0 , 3, 6, 9 and 12 weeks
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0 , 3, 6, 9 and 12 weeks
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Frequent daily evacuations
Délai: 4 Weeks
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Frequent daily evacuations, format and consistency of the feces, total and segmental transit time.
The format and consistency of the feces was evaluated in accordance with the Bristol Stool Form Scale (stool are rated based on water content of the feces, with 1 meaning hard stools to 7 meaning liquid stools)
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4 Weeks
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Adherence and Tolerance Parameters
Délai: 0 , 3, 6, 9 and 12 weeks
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Adherence and Tolerance Parameters: adherence and tolerance to the products and diet prescribed
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0 , 3, 6, 9 and 12 weeks
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Carmen Gomez Candela, PhD, Hospital Universitario La Paz
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ALIBIRDII
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