Nutrigenomics And Children Obesity: A Moderate Weight Loss Intervention Study

Efecto de Una Intervención Dietética Sobre La Expresión De Genes De La Inflamación Y El Estrés Oxidativo En Niños Obesos

Patrocinadores

Patrocinador principal: Clinica Universidad de Navarra, Universidad de Navarra

Colaborador: Hospital Virgen del Camino

Fuente Clinica Universidad de Navarra, Universidad de Navarra
Resumen breve

The consumption of diets enriched in proteins (legumes and fish) or antioxidant (fruits and vegetables) could have beneficial effects beyond those of the caloric restriction on biomarkers of the inflammatory and oxidative status. OBJECTIVE: To address the effect of a 10-week dietary intervention aimed to weight loss in obese or overweight children (7-15 aged) on genomics, particularly the changes in the expression of genes related to the inflammatory status and oxidative stress. METHODOLOGY: 44 Navarra children and adolescents of both sexes from Pediatric Endocrinology Services at different Hospitals in Pamplona will be recruited. The effect of the intensive consumption of different groups of food will be evaluated: legumes and fish ( diets in proteins) and vegetable and fruits (rich diets in antioxidants). Before and after the intervention, the following items will be analyzed: (1) the diet of the subjects, (2) body composition and 3 magnitudes related to biological and development parameters, being: (3) lipid and metabolic phenotypic profile; (4) markers of the inflammatory status and oxidative stress, and (5) the genomic profile. The dietary programme will be implemented both in group workshops addresseded to patients and their family, and in individual sessions with the pediatricians and/or registered dieticians. Finally, the programme efficacy will be evaluated by the scoreboards integrated in the 5 variables already mentioned.

Descripción detallada

A longitudinal intervention study in 44 overweight and obese adolescents (23 females and 21 males; mean age 11.5 years) for 10 weeks based on a calorie restricted diet (20-40%) according to obesity degree.

Estado general Completed
Fecha de inicio January 2010
Fecha de Terminación March 2020
Fecha de finalización primaria September 2011
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Body masss index week 0
Resultado secundario
Medida Periodo de tiempo
Basal glucose concentration week 10
Insulin concentrations week 0
Inscripción 42
Condición
Intervención

Tipo de intervención: Behavioral

Nombre de intervención: Control group

Descripción: Subjects will receive Nutritional education together with weight management counselling for overweight and obesity. -10 weekly personal interviews with a registered nutritionist for body weight control.

Etiqueta de grupo de brazo: Control group

Tipo de intervención: Behavioral

Nombre de intervención: Protein group

Descripción: Participants will receive Nutritional education and personalised structured meal plan with a calorie restricted diet (20-40% of the subject's energy expenditure at baseline) according to obesity degree, encouraging high consumption of legumes and fish (protein rich diets). -10 weekly personal interviews with a registered nutritionist for body weight control.

Etiqueta de grupo de brazo: Protein group

Tipo de intervención: Behavioral

Nombre de intervención: Antioxidant group

Descripción: Participants will receive Nutritional education and personalized structured meal plan with a calorie restricted diet (20-40% of the subject's energy expenditure at baseline) according to obesity degree, encouraging high consumption of fruits and vegetables (antioxidant rich diets). -10 weekly personal interviews with a registered nutritionist for body weight control.

Etiqueta de grupo de brazo: Antioxidant group

Elegibilidad

Criterios:

Inclusion Criteria:

- Children between 7 and 15 years

- Body Mass Index (BMI) higher to 97 percentile. (Cole et al, 2000)*

- Cole TJ, Belizzy MC, Flegal KM, Dietz WH. Br Med J 2000; 320: 1-6.

Exclusion Criteria:

- Use of prescription medication

- To suffer from any major psychiatry or neurological disease, bulimia nervosa, familiar hypercholesterolemia or any major cardiac, or respiratory metabolic disease.

Género: All

Edad mínima: 7 Years

Edad máxima: 15 Years

Voluntarios Saludables: No

Oficial general
Ubicación
Instalaciones:
UNavarre | Pamplona, Navarra, 31008, Spain
University of Navarre | Pamplona, Navarra, 31008, Spain
Ubicacion Paises

Spain

Fecha de verificación

March 2020

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 3
Grupo de brazo

Etiqueta: Control group

Tipo: Active Comparator

Descripción: Control group: Subjects will receive Nutritional education together with weight management counselling for overweight and obesity. -10 weekly personal interviews with a registered nutritionist for body weight control.

Etiqueta: Protein group

Tipo: Experimental

Descripción: Protein group: Participants will receive Nutritional education and personalised structured meal plan with a calorie restricted diet (20-40% of the subject's energy expenditure at baseline) according to obesity degree, encouraging high consumption of legumes and fish (protein rich diets). -10 weekly personal interviews with a registered nutritionist for body weight control.

Etiqueta: Antioxidant group

Tipo: Experimental

Descripción: Antioxidant group: Participants will receive Nutritional education and personalized structured meal plan with a calorie restricted diet (20-40% of the subject's energy expenditure at baseline) according to obesity degree, encouraging high consumption of fruits and vegetables (antioxidant rich diets). -10 weekly personal interviews with a registered nutritionist for body weight control.

Acrónimo NUGENOI
Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov