- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Madrid, España, 28061
- Hospital Universitario La Paz
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: 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
Otros nombres:
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Comparador de placebos: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Changes in body composition
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Life style and health status: Life style and physical activity questionnaire
Periodo de tiempo: Week 0 and Week 12
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Week 0 and Week 12
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Genetic analysis
Periodo de tiempo: Week 0 and Week 12
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Week 0 and Week 12
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Metabolomic analyses
Periodo de tiempo: Week 0 and Week 12
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Week 0 and Week 12
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Endothelial function markers
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Appetite and satiety
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Investigadores
- Investigador principal: Carmen Gomez Candela, PhD, Hospital Universitario La Paz
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ALIBIRDII
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