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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
Sponsor:
Information provided by (Responsible Party):
Fernando Guerrero Romero MD, Coordinación de Investigación en Salud, Mexico

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.

Condition or disease Intervention/treatment Phase
Obesity in Childhood Dietary Supplement: Agave inulin Dietary Supplement: Curcumin Dietary Supplement: O3FA Behavioral: Control Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Experimental: Curcumin
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

Control
Recommendations to decrease calories intake an do exercise.
Behavioral: Control
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 Outcome Measures :
  1. Loosing weight [ Time Frame: Three months ]
    Weight lost between basal and third month visits. Determined by a digital scale



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670875


Contacts
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Contact: Guerrero +526188120997 guerrero.romero@gmail.com
Contact: Gerardo Martinez +526188120997 uimec@yahoo.es

Locations
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Mexico
Biomedical Research Unit. IMSS. Durango Recruiting
Durango, Dgo, Mexico, 34067
Contact: Fernando Guerrero, PhD    +526188120997    guerrero.romero@gmail.com   
Contact: Gerardo Martinez, PhD    +526188120997    uimec@yahoo.es   
Sub-Investigator: Luis Simental, PhD         
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Investigators
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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

Additional Information:
Publications:
González-Herrera SM, Rutiaga-Quiñones OM, Aguilar CN, et al. Dehydrated Apple matrix supplemented with agave fructans, inulin and oligofructose. LWT Food Science and Technology. 2016;65:1059-1065.
Nagwa I, Ragab S, Baky A, et al. Effect of Oral Curcumin Administration on Insulin Resistance, Serum Resistin and Fetuin-A in Obese Children: Randomized Placebo- Controlled study. Reser J of Pharm, Biol and Chem Sci 2014 5:887-96

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Responsible Party: Fernando Guerrero Romero MD, Head of the research unit, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT03670875     History of Changes
Other Study ID Numbers: R-2016-785-103
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fernando Guerrero Romero MD, Coordinación de Investigación en Salud, Mexico:
Children, obesity, agave-inulin, curcumin, O3FA
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action