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

March 23, 2020 updated by: Clinica Universidad de Navarra, Universidad de Navarra

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • UNavarre
      • Pamplona, Navarra, Spain, 31008
        • University of Navarre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control group

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

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.
EXPERIMENTAL: Protein group

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

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.
EXPERIMENTAL: Antioxidant group

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
week 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
week 10
Insulin concentrations
Time Frame: week 0
Insulin concentrations will be analysed at week 0, and 10.
week 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Collaborators

Hospital Virgen del Camino

Investigators

  • Principal Investigator: Amelia Marti, PhD, BPharm, University of Navarra
  • Study Director: Cristina Azcona, MD, University of Navarre Clinic
  • Study Chair: Maria Chueca, MD, Virgen del Camino Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

March 1, 2020

Study Registration Dates

First Submitted

January 20, 2011

First Submitted That Met QC Criteria

April 4, 2011

First Posted (ESTIMATE)

April 5, 2011

Study Record Updates

Last Update Posted (ACTUAL)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUGENOI-UN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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