Nutrigenomics And Children Obesity: A Moderate Weight Loss Intervention Study

Obesity Clinical Trial

— NUGENOI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01329367
• Other study ID #: NUGENOI-UN
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: March 2020

Study information

• Verified date: March 2020
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2020
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Spain	UNavarre	Pamplona	Navarra
Spain	University of Navarre	Pamplona	Navarra

Sponsors (2)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra	Hospital Virgen del Camino

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Marti A, Morell-Azanza L, Rendo-Urteaga T, García-Calzón S, Ojeda-Rodríguez A, Martín-Calvo N, Moreno-Aliaga MJ, Martínez JA, Azcona-San Julián MC. Serum and gene expression levels of CT-1, IL-6, and TNF-a after a lifestyle intervention in obese children. — View Citation

Morell-Azanza L, García-Calzón S, Rendo-Urteaga T, Martin-Calvo N, Chueca M, Martínez JA, Azcona-Sanjulián MC, Marti A. Serum oxidized low-density lipoprotein levels are related to cardiometabolic risk and decreased after a weight loss treatment in obese — View Citation

Ojeda-Rodríguez A, Morell-Azanza L, Azcona-Sanjulián MC, Martínez JA, Ramirez MJ, Marti A. Reduced serotonin levels after a lifestyle intervention in obese children: association with glucose and anthropometric measurements. Nutr Hosp. 2018 Mar 1;35(2):279 — View Citation

Rendo-Urteaga T, García-Calzón S, González-Muniesa P, Milagro FI, Chueca M, Oyarzabal M, Azcona-Sanjulián MC, Martínez JA, Marti A. Peripheral blood mononuclear cell gene expression profile in obese boys who followed a moderate energy-restricted diet: dif — View Citation

Rendo-Urteaga T, García-Calzón S, Martínez-Ansó E, Chueca M, Oyarzabal M, Azcona-Sanjulián MC, Bustos M, Moreno-Aliaga MJ, Martínez JA, Marti A. Decreased cardiotrophin-1 levels are associated with a lower risk of developing the metabolic syndrome in over — View Citation

Rendo-Urteaga T, Puchau B, Chueca M, Oyarzabal M, Azcona-Sanjulián MC, Martínez JA, Marti A. Total antioxidant capacity and oxidative stress after a 10-week dietary intervention program in obese children. Eur J Pediatr. 2014 May;173(5):609-16. doi: 10.100 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body masss index	Body mas index will be measured at the beginning of the study (week 0), at week 5 and week 10 (end of the study).	week 0
Secondary	Basal glucose concentration	Basal glucose concentration will be measured at the beginning of the study (week 0)and week 10 (end of the study).	week 10
Secondary	Insulin concentrations	Insulin concentrations will be analysed at week 0, and 10.	week 0