Nutrigenomics And Children Obesity: A Moderate Weight Loss Intervention Study

Summary

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.

Conditions

• Obesity

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• Hospital Virgen del Camino

  collaborator OTHER

• Clinica Universidad de Navarra, Universidad de Navarra

  lead OTHER

Principal Investigators

• Amelia Marti, PhD, BPharm · University of Navarra

• Cristina Azcona, MD · University of Navarre Clinic

• Maria Chueca, MD · Virgen del Camino Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2011-09-30

Completion

2020-03-31

Countries

• Spain

Study Locations