Overview

This trial is active, not recruiting.

Condition obesity
Treatment moderate weight loss intervention
Sponsor Clinica Universidad de Navarra, Universidad de Navarra
Collaborator Hospital Virgen del Camino
Start date January 2010
End date September 2011
Trial size 42 participants
Trial identifier NCT01329367, NUGENOI-UN

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Arm
(Active Comparator)
Nutritional education together with weight management counselling for overweight and obesity. -10 weekly personal interviews with a registered nutritionist for body weight control.
moderate weight loss intervention EVASYON study
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.
(Experimental)
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 legumes and fish (protein rich diets). -10 weekly personal interviews with a registered nutritionist for body weight control.
moderate weight loss intervention EVASYON study
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.
(Experimental)
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.
moderate weight loss intervention EVASYON study
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.

Primary Outcomes

Measure
Body masss index
time frame: week 0
Body mas index
time frame: week 5
Body mass index
time frame: week 10

Secondary Outcomes

Measure
Basal glucose concentration
time frame: week 10
Basal Insulin Concentration
time frame: week 10
Basal glucose concentration
time frame: week 0
Insulin concentrations
time frame: week 0

Eligibility Criteria

Male or female participants from 7 years up to 15 years old.

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.

Additional Information

Official title Efecto de Una Intervención Dietética Sobre La Expresión De Genes De La Inflamación Y El Estrés Oxidativo En Niños Obesos
Principal investigator Amelia Marti, PhD, BPharm
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by Clinica Universidad de Navarra, Universidad de Navarra.