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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hospital Virgen del Camino
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT01329367
First received: January 20, 2011
Last updated: October 5, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention
Obesity
 Other: Moderate weight loss intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Efecto de Una Intervención Dietética Sobre La Expresión De Genes De La Inflamación Y El Estrés Oxidativo En Niños Obesos

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:

Primary Outcome Measures:
  • Body masss index [ Time Frame: week 0 ] [ Designated as safety issue: No ]
    Body mas index will be measured at the beginning of the study (week 0), at week 5 and week 10 (end of the study).

  • Body mas index [ Time Frame: week 5 ] [ Designated as safety issue: No ]
    Body mas index will be measured at the beginning of the study (week 0), at week 5 and week 10 (end of the study).

  • Body mass index [ Time Frame: week 10 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 10 ] [ Designated as safety issue: No ]
    Basal glucose concentration will be measured at the beginning of the study (week 0)and week 10 (end of the study).

  • Basal Insulin Concentration [ Time Frame: week 10 ] [ Designated as safety issue: No ]
    Insulin concentrations will be analysed at week 0, and 10.

  • Basal glucose concentration [ Time Frame: week 0 ] [ Designated as safety issue: No ]
    Basal glucose concentration will be measured at the beginning of the study (week 0)and week 10 (end of the study).

  • Insulin concentrations [ Time Frame: week 0 ] [ Designated as safety issue: No ]
    Insulin concentrations will be analysed at week 0, and 10.


Estimated Enrollment: 42
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control group:

Nutritional education together with weight management counselling for overweight and obesity.

-10 weekly personal interviews with a registered nutritionist for body weight control.

 Other: Moderate weight loss intervention
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.
Other Names:
  • EVASYON study
  • GENOI
Experimental: Protein group:

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.

 Other: Moderate weight loss intervention
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.
Other Names:
  • EVASYON study
  • GENOI
Experimental: Antioxidant group:

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.

 Other: Moderate weight loss intervention
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.
Other Names:
  • EVASYON study
  • GENOI

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.

  Eligibility

Ages Eligible for Study:   7 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329367

Locations
Spain
University of Navarre
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Hospital Virgen del Camino
Investigators
Principal Investigator: Amelia Marti, PhD, BPharm University of Navarra
Study Director: Cristina Azcona, MD University of Navarre Clinic
Study Chair: Maria Chueca, MD Virgen del Camino Hospital
  More Information

Publications:

Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT01329367     History of Changes
Other Study ID Numbers: NUGENOI-UN
Study First Received: January 20, 2011
Last Updated: October 5, 2011
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
EVASYON
GENOI
antioxidants
legume
fish

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013