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NCT Number: NCT01329367

Nutrigenomics And Children Obesity: A Moderate Weight Loss Intervention Study

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNavarre, Pamplona, Navarre, Spain

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About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control Group

Behavioral

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.

Protein group

Behavioral

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.

Antioxidant group

Behavioral

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.

Primary outcomes

  1. Body masss index

    Time frame: 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 outcomes

  1. Basal glucose concentration

    Time frame: week 10

    Basal glucose concentration will be measured at the beginning of the study (week 0)and week 10 (end of the study).

  2. Insulin concentrations

    Time frame: week 0

    Insulin concentrations will be analysed at week 0, and 10.

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Collaborators

  • Hospital Virgen del Camino

Registry information

Official study title

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

Acronym: NUGENOI

Important dates

Study start
2010
Primary completion
2011
Study completion
2020
First posted
Apr 5, 2011
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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