Non-Pharmacologic Alternatives for Childhood Obesity
Condition: Obesity in Childhood
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      Childhood obesity is a global health issue. Mexico has been considered as the country with
      the higher number of children with obesity. There are not approved drugs to support diet and
      exercise as the first step to lose weight. Animal models and clinical trials in adults have
      provided evidence about safety and efficacy of interventions such as: prebiotics, curcumin,
      and omega- 3 fatty acids. The hypothesis of this study is: that non-pharmacological
      alternatives could support diet and exercise to decrease the weight of children with obesity.
    

Detailed description: 
      The aim of this study is to determinate the efficacy and safety of agave inulin, curcumin,
      and omega-3 fatty acids (O3FA) to decrease the weight of children with obesity.

      Design. Randomized controlled clinical trial (RCT) with four study groups: agave inulin,
      curcumin, omega-3 fatty acids and a control group. All groups will receive instructions to
      decrease calories intake and do exercise.

      Children sent to the unit with a presumptive diagnosis of obesity will be considered as
      candidates to the RCT. Children accomplishing with inclusion/exclusion criteria will be
      randomized to one of the study groups.

      Sample size was calculated using a statistical power of 80%, alpha value of 0.05. A 15 % of
      difference, in the mean of weight reduction, between control group and intervention groups
      was considered. The estimated sample size was 75 subjects for each group.

      Weight, height, BMI, blood pressure, abdominal circumference and body fat percentage will be
      measured in months 0, 1, 2, and 3. In months 0 and 3 a fasting venous blood sample will be
      drawn to perform the following test: glucose, insulin, lipid profile and C- Reactive protein,
      aspartate aminotransferase (AST) and alanine aminotransferase (ALT). Anthropometric measures,
      food intake recommendation and diaries of food consume will be performed by trained
      nutritionists. Recommendation about type of exercise and estimation of calories consumed will
      be performed by a physical education teacher.

      The statistical analysis will performed by one to the investigators blinded to treatment
      groups. Numerical values will be expressed as mean ± standard deviation. Categorical
      variables will be expressed as proportions. The analysis will be preformed according with
      CONSORT group recommendations Differences between the groups were estimated using one-way
      ANOVA with Bonferroni post-hoc test for numerical parameters and χ 2 test for categorical
      variables. Intragroup differences will be assessed by paired Student t test (Mann-Whitney U
      test for skewed data). Statistical significance will be considered as a p value <0.05 and 95%
      confidence interval (CI). Statistical Package for the Social Sciences will be used for the
      analysis
    

Intervention name(s): Agave inulin; Curcumin; O3FA; Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Behavioral
Intervention description(s): Will be provided in dehydrated apple cubes; Will be provided in capsules; Will be provided in capsules; Dietary recommendations to ingest 1600 calories per day. Exercise: 30 minutes each day, al least 5 days a week (caloric consumption 150-200 kcal per day)
Other intervention name(s): Turmeric
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study groups. Agave inulin: 2.3 g twice a day by mouth during 3 months plus recommendations to decrease calories intake an do exercise.
Curcumin: 600 mg (turmeric 600 + black pepper 5 mg) by mouth daily during 3 months plus recommendations to decrease calories intake an do exercise.
Omega-3 fatty acids 600 mg (eicosapentaenoic acid 360; docosahexaenoic acid 240) Three times a day by mouth during 3 months plus recommendations to decrease calories intake an do exercise.
Control group with no intervention. Recommendations to decrease calories intake an do exercise.
Dietary recommendations to ingest 1600 calories per day Exercise: 30 minutes each day, al least 5 days a week (caloric consumption 150-200 kcal per day)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Children, obesity, agave-inulin, curcumin, O3FA