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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Control group
Protein group
Antioxidant group
Sponsored by
Clinica Universidad de Navarra, Universidad de Navarra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring EVASYON, GENOI, antioxidants, legume, fish

Eligibility Criteria

7 Years - 15 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • UNavarre
  • University of Navarre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control group

Protein group

Antioxidant group

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
January 20, 2011
Last Updated
March 23, 2020
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Collaborators
Hospital Virgen del Camino
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1. Study Identification

Unique Protocol Identification Number
NCT01329367
Brief Title
Nutrigenomics And Children Obesity: A Moderate Weight Loss Intervention Study
Acronym
NUGENOI
Official Title
Efecto de Una Intervención Dietética Sobre La Expresión De Genes De La Inflamación Y El Estrés Oxidativo En Niños Obesos
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Collaborators
Hospital Virgen del Camino

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
EVASYON, GENOI, antioxidants, legume, fish

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Protein group
Arm Type
Experimental
Arm Description
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.
Arm Title
Antioxidant group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Protein group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Antioxidant group
Intervention Description
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 Outcome Measure Information:
Title
Body masss index
Description
Body mas index will be measured at the beginning of the study (week 0), at week 5 and week 10 (end of the study).
Time Frame
week 0
Secondary Outcome Measure Information:
Title
Basal glucose concentration
Description
Basal glucose concentration will be measured at the beginning of the study (week 0)and week 10 (end of the study).
Time Frame
week 10
Title
Insulin concentrations
Description
Insulin concentrations will be analysed at week 0, and 10.
Time Frame
week 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amelia Marti, PhD, BPharm
Organizational Affiliation
University of Navarra
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cristina Azcona, MD
Organizational Affiliation
University of Navarre Clinic
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maria Chueca, MD
Organizational Affiliation
Virgen del Camino Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
UNavarre
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
University of Navarre
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25471305
Citation
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.
Results Reference
result
PubMed Identifier
24310523
Citation
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.
Results Reference
result
PubMed Identifier
23856329
Citation
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.
Results Reference
result
PubMed Identifier
29756959
Citation
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.
Results Reference
result
PubMed Identifier
27435258
Citation
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.
Results Reference
result
PubMed Identifier
28749076
Citation
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.
Results Reference
result

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Nutrigenomics And Children Obesity: A Moderate Weight Loss Intervention Study

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