Clinical trial NCT03670875: Non-Pharmacologic Alternatives for Childhood Obesity
Official title: Non-Pharmacologic Alternatives for the Treatment of Childhood Obesity in Mexico
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity in Childhood
Keywords: Children, obesity, agave-inulin, curcumin, O3FA
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2018-09-14
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

* Gender: Boys and Girls
* Diagnosis of obesity (percentile ≥ 95% according to The Centers for Disease Control and Prevention growth charts)
* Informed consent of parents
* Informed assent of the participant

Exclusion criteria:

* Diabetes
* Thyroid disease
* Renal disease
* Hepatic disease
* Neoplasia disease
* Chronic gastrointestinal conditions
* Consume of prebiotics or probiotics
* Consume of prebiotics or food supplements
* Use of anti-inflammatory drugs.
* Recent use of antibiotics (30 days)

Primary outcomes:
measure: Loosing weight
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Durango
country: Mexico
facility: Biomedical Research Unit. IMSS. Durango
state: Dgo
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Fernando Guerrero, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Mexicano del Seguro Social
name: Gerardo Martinez, PhD
role: STUDY_DIRECTOR
affiliation: Instituto Mexicano del Seguro Social
name: Luis E Simental, PhD
role: STUDY_CHAIR
affiliation: Instituto Mexicano del Seguro Social
name: Claudia I Gamboa, PhD
role: STUDY_CHAIR
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