NUGENOI: Nutrigenomics And Children Obesity: A Moderate Weight Loss Intervention Study

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra (Other)

Overall Status

Completed

CT.gov ID

NCT01329367

Collaborator

Hospital Virgen del Camino (Other)

Enrollment

Locations

Arms

122

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Control group Behavioral: Protein group Behavioral: Antioxidant group	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control group 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: 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.
Experimental: Protein group 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: 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.
Experimental: Antioxidant group 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.	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.

Arm

Intervention/Treatment

Active Comparator: Control group

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: 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.

Experimental: Protein group

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: 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.

Experimental: Antioxidant group

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.

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.

Outcome Measures

Primary Outcome Measures

Body masss index [week 0]
Body mas index will be measured at the beginning of the study (week 0), at week 5 and week 10 (end of the study).

Secondary Outcome Measures

Basal glucose concentration [week 10]
Basal glucose concentration will be measured at the beginning of the study (week 0)and week 10 (end of the study).
Insulin concentrations [week 0]
Insulin concentrations will be analysed at week 0, and 10.

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.