Nutrigenomics And Children Obesity: A Moderate Weight Loss Intervention Study

NCT01329367 | Completed

• 1 other identifier: NUGENOI-UN
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity

Keywords

EVASYON; GENOI; antioxidants; legume; fish

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Basal glucose concentration

  week 10

• Insulin concentrations

  week 0

Study Arms (3)

Control group

ACTIVE COMPARATOR

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

Protein group

EXPERIMENTAL

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

Antioxidant group

EXPERIMENTAL

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

Interventions

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.

Control group

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.

Protein group

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.

Antioxidant group

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• Hospital Virgen del Camino: collaborator

Study Sites (2)

UNavarre

Pamplona, Navarre, 31008, Spain

Location

University of Navarre

Pamplona, Navarre, 31008, Spain

Location

Related Publications (6)

• Rendo-Urteaga T, Garcia-Calzon S, Gonzalez-Muniesa P, Milagro FI, Chueca M, Oyarzabal M, Azcona-Sanjulian MC, Martinez JA, Marti A. Peripheral blood mononuclear cell gene expression profile in obese boys who followed a moderate energy-restricted diet: differences between high and low responders at baseline and after the intervention. Br J Nutr. 2015 Jan 28;113(2):331-42. doi: 10.1017/S0007114514003584. Epub 2014 Dec 4.

  PMID: 25471305 RESULT

• Rendo-Urteaga T, Puchau B, Chueca M, Oyarzabal M, Azcona-Sanjulian MC, Martinez 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: 10.1007/s00431-013-2229-7. Epub 2013 Dec 6.

  PMID: 24310523 RESULT

• Rendo-Urteaga T, Garcia-Calzon S, Martinez-Anso E, Chueca M, Oyarzabal M, Azcona-Sanjulian MC, Bustos M, Moreno-Aliaga MJ, Martinez JA, Marti A. Decreased cardiotrophin-1 levels are associated with a lower risk of developing the metabolic syndrome in overweight/obese children after a weight loss program. Metabolism. 2013 Oct;62(10):1429-36. doi: 10.1016/j.metabol.2013.05.011. Epub 2013 Jul 12.

  PMID: 23856329 RESULT

• Ojeda-Rodriguez A, Morell-Azanza L, Azcona-Sanjulian MC, Martinez 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):279-285. doi: 10.20960/nh.1439.

  PMID: 29756959 RESULT

• Morell-Azanza L, Garcia-Calzon S, Rendo-Urteaga T, Martin-Calvo N, Chueca M, Martinez JA, Azcona-Sanjulian MC, Marti A. Serum oxidized low-density lipoprotein levels are related to cardiometabolic risk and decreased after a weight loss treatment in obese children and adolescents. Pediatr Diabetes. 2017 Aug;18(5):392-398. doi: 10.1111/pedi.12405. Epub 2016 Jul 20.

  PMID: 27435258 RESULT

• Marti A, Morell-Azanza L, Rendo-Urteaga T, Garcia-Calzon S, Ojeda-Rodriguez A, Martin-Calvo N, Moreno-Aliaga MJ, Martinez JA, Azcona-San Julian MC. Serum and gene expression levels of CT-1, IL-6, and TNF-alpha after a lifestyle intervention in obese children. Pediatr Diabetes. 2018 Mar;19(2):217-222. doi: 10.1111/pedi.12561. Epub 2017 Jul 27.

  PMID: 28749076 RESULT

MeSH Terms

Conditions

Obesity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Amelia Marti, PhD, BPharm

  University of Navarra

  PRINCIPAL INVESTIGATOR

• Cristina Azcona, MD

  University of Navarre Clinic

  STUDY DIRECTOR

• Maria Chueca, MD

  Virgen del Camino Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2011
• First Posted: April 5, 2011
• Study Start: January 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: March 1, 2020
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)