Efecto de Una Intervención Dietética Sobre La Expresión De Genes De La Inflamación Y El Estrés Oxidativo En Niños Obesos
Nutrigenomics And Children Obesity: A Moderate Weight Loss Intervention Study
Sponsors
Lead Sponsor
Collaborators
Source
Clinica Universidad de Navarra, Universidad de Navarra
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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.
Overall Status
Active, not recruiting
Start Date
2010-01-01
Completion Date
2019-12-01
Primary Completion Date
2011-09-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Body masss index |
week 0 |
Secondary Outcome
Measure |
Time Frame |
|
Basal glucose concentration |
week 10 |
|
Insulin concentrations |
week 0 |
Enrollment
42
Condition
Intervention
Intervention Type
Behavioral
Intervention Name
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.
Arm Group Label
Control group
Intervention Type
Behavioral
Intervention Name
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.
Arm Group Label
Protein group
Intervention Type
Behavioral
Intervention Name
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.
Arm Group Label
Antioxidant group
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.
Gender
All
Minimum Age
7 Years
Maximum Age
15 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Amelia Marti, PhD, BPharm |
Principal Investigator |
University of Navarra |
|
Cristina Azcona, MD |
Study Director |
University of Navarre Clinic |
|
Maria Chueca, MD |
Study Chair |
Virgen del Camino Hospital |
Location
Facility |
|
UNavarre Pamplona Navarra 31008 Spain |
|
University of Navarre Pamplona Navarra 31008 Spain |
Location Countries
Country
Spain
Verification Date
2018-10-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
3
Intervention Browse
Mesh Term
Antioxidants
Arm Group
Arm Group Label
Control group
Arm Group Type
Active Comparator
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 Group Label
Protein group
Arm Group Type
Experimental
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 Group Label
Antioxidant group
Arm Group Type
Experimental
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.
Results Reference
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: 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
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: 10.1007/s00431-013-2229-7. Epub 2013 Dec 6.
PMID
24310523
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 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
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):279-285. doi: 10.20960/nh.1439.
PMID
29756959
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 children and adolescents. Pediatr Diabetes. 2017 Aug;18(5):392-398. doi: 10.1111/pedi.12405. Epub 2016 Jul 20.
PMID
27435258
Citation
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-α 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
Firstreceived Results Date
N/A
Acronym
NUGENOI
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
January 20, 2011
Study First Submitted Qc
April 4, 2011
Study First Posted
April 5, 2011
Last Update Submitted
October 15, 2018
Last Update Submitted Qc
October 15, 2018
Last Update Posted
October 17, 2018
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.