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ObesityNUGENOINCT01329367

Nutrigenomics And Children Obesity: A Moderate Weight Loss Intervention Study

A study testing Protein group and Antioxidant group in people with Obesity, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 7 to 15 years
Conditions the study is for
Obesity
What is being tested?
Protein group and Antioxidant group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
2 sitesSpain
Study dates
Jan 2010to Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • UNavarre

    Pamplona, Navarre, 31008

  • University of Navarre

    Pamplona, Navarre, 31008

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Conditions
Obesity
Being tested
Control group, Protein group, Antioxidant group
Keywords
EVASYON, GENOI, antioxidants, legume, fish
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control groupBehavioural

    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 groupBehavioural

    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 groupBehavioural

    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.

Study groups in NCT01329367
Study groupRoleWhat they receive
Control groupActive comparatorControl 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.
Receives: Behavioral: Control group
Protein groupExperimentalProtein 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.
Receives: Behavioral: Protein group
Antioxidant groupExperimentalAntioxidant 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.
Receives: Behavioral: Antioxidant group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: week 0

Secondary outcomes (2)

  1. Basal glucose concentration

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

    Measured: week 10

  2. Insulin concentrations

    Insulin concentrations will be analysed at week 0, and 10.

    Measured: week 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2011 (estimated)
  2. Study startJan 2010
  3. Primary completionSep 2011
  4. Study completionMar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01329367
Sponsor's protocol ID
NUGENOI-UN
Acronym
NUGENOI
Status last verified
Mar 2020
First submitted
20 Jan 2011
Last updated
24 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25471305

  • 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.

    PubMed 24310523

  • 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.

    PubMed 23856329

  • 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.

    PubMed 29756959

  • 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.

    PubMed 27435258

  • 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.

    PubMed 28749076

Questions about this trial

What is this clinical trial studying?

A study testing Protein group and Antioxidant group in people with Obesity, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body masss index (time frame: week 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01329367, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.

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