Non-Pharmacologic Alternatives for Childhood Obesity
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|ClinicalTrials.gov Identifier: NCT03670875|
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : April 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity in Childhood||Dietary Supplement: Agave inulin Dietary Supplement: Curcumin Dietary Supplement: O3FA Behavioral: Control||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|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)|
|Official Title:||Non-Pharmacologic Alternatives for the Treatment of Childhood Obesity in Mexico|
|Actual Study Start Date :||January 8, 2018|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||December 30, 2020|
Experimental: Agave inulin
Agave inulin 2.3 g, by mouth, every 12 hours for 3 months. Plus recommendations to decrease calories intake an do exercise.
Dietary Supplement: Agave inulin
Will be provided in dehydrated apple cubes
Curcumin 600 mg (turmeric 600 + black pepper 5 mg) by mouth, daily for 3 months. Plus recommendations to decrease calories intake an do exercise.
Dietary Supplement: Curcumin
Will be provided in capsules
Other Name: Turmeric
Experimental: Omega 3 Fatty Acids
O3FA 600 mg (eicosapentaenoic acid 360; docosahexaenoic acid 240) Three times a day by mouth, every 8 hours for 3 months. Plus recommendations to decrease calories intake an do exercise.
Dietary Supplement: O3FA
Will be provided in capsules
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)
- Loosing weight [ Time Frame: Three months ]Weight lost between basal and third month visits. Determined by a digital scale
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670875
|Contact: Gerardo Martinezemail@example.com|
|Biomedical Research Unit. IMSS. Durango||Recruiting|
|Durango, Dgo, Mexico, 34067|
|Contact: Fernando Guerrero, PhD +526188120997 firstname.lastname@example.org|
|Contact: Gerardo Martinez, PhD +526188120997 email@example.com|
|Sub-Investigator: Luis Simental, PhD|
|Principal Investigator:||Fernando Guerrero, PhD||Instituto Mexicano del Seguro Social|
|Study Director:||Gerardo Martinez, PhD||Instituto Mexicano del Seguro Social|
|Study Chair:||Luis E Simental, PhD||Instituto Mexicano del Seguro Social|
|Study Chair:||Claudia I Gamboa, PhD||Instituto Mexicano del Seguro Social|