Nutrigenomics And Children Obesity: A Moderate Weight Loss Intervention Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2020-03-31

Brief Summary

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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.

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Detailed Description

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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

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Protein group

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Antioxidant group

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No