Non-Pharmacologic Alternatives for Childhood Obesity

Obesity in Childhood Clinical Trial

Official title:

Non-Pharmacologic Alternatives for the Treatment of Childhood Obesity in Mexico

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03670875
• Other study ID #: R-2016-785-103
• Status: Completed
• Phase: N/A
• Start date: July 31, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: September 2023
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 30, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity
• Obesity in Childhood
• Pediatric Obesity

Intervention

Dietary Supplement:
• Agave inulin
Will be provided in dehydrated apple cubes
• Curcumin
Will be provided in capsules
• O3FA
Will be provided in capsules

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)

Locations

Country	Name	City	State
Mexico	Biomedical Research Unit. IMSS. Durango	Durango	Dgo

Sponsors (1)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (15)

Couet C, Delarue J, Ritz P, Antoine JM, Lamisse F. Effect of dietary fish oil on body fat mass and basal fat oxidation in healthy adults. Int J Obes Relat Metab Disord. 1997 Aug;21(8):637-43. doi: 10.1038/sj.ijo.0800451. — View Citation

Gluckman P, Nishtar S, Armstrong T. Ending childhood obesity: a multidimensional challenge. Lancet. 2015 Mar 21;385(9973):1048-50. doi: 10.1016/S0140-6736(15)60509-8. No abstract available. — View Citation

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.

Huang XF, Xin X, McLennan P, Storlien L. Role of fat amount and type in ameliorating diet-induced obesity: insights at the level of hypothalamic arcuate nucleus leptin receptor, neuropeptide Y and pro-opiomelanocortin mRNA expression. Diabetes Obes Metab. 2004 Jan;6(1):35-44. doi: 10.1111/j.1463-1326.2004.00312.x. — View Citation

Juarez-Lopez C, Klunder-Klunder M, Madrigal-Azcarate A, Flores-Huerta S. Omega-3 polyunsaturated fatty acids reduce insulin resistance and triglycerides in obese children and adolescents. Pediatr Diabetes. 2013 Aug;14(5):377-83. doi: 10.1111/pedi.12024. Epub 2013 Feb 25. — View Citation

Lopez-Velazquez G, Diaz-Garcia L, Anzo A, Parra-Ortiz M, Llamosas-Gallardo B, Ortiz-Hernandez AA, Mancilla-Ramirez J, Cruz-Rubio JM, Gutierrez-Castrellon P. Safety of a dual potential prebiotic system from Mexican agave "Metlin(R) and Metlos(R)", incorporated to an infant formula for term newborn babies: a randomized controlled trial. Rev Invest Clin. 2013 Nov-Dec;65(6):483-90. — View Citation

Mancilla-Margalli NA, Lopez MG. Water-soluble carbohydrates and fructan structure patterns from Agave and Dasylirion species. J Agric Food Chem. 2006 Oct 4;54(20):7832-9. doi: 10.1021/jf060354v. — View Citation

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

Parra D, Ramel A, Bandarra N, Kiely M, Martinez JA, Thorsdottir I. A diet rich in long chain omega-3 fatty acids modulates satiety in overweight and obese volunteers during weight loss. Appetite. 2008 Nov;51(3):676-80. doi: 10.1016/j.appet.2008.06.003. Epub 2008 Jun 14. — View Citation

Ramirez-Bosca A, Soler A, Carrion MA, Diaz-Alperi J, Bernd A, Quintanilla C, Quintanilla Almagro E, Miquel J. An hydroalcoholic extract of curcuma longa lowers the apo B/apo A ratio. Implications for atherogenesis prevention. Mech Ageing Dev. 2000 Oct 20;119(1-2):41-7. doi: 10.1016/s0047-6374(00)00169-x. — View Citation

Sahebkar A. Why it is necessary to translate curcumin into clinical practice for the prevention and treatment of metabolic syndrome? Biofactors. 2013 Mar-Apr;39(2):197-208. doi: 10.1002/biof.1062. Epub 2012 Dec 13. Erratum In: Biofactors. 2013 Sep-Oct;39(5):591. — View Citation

Siro I, Kapolna E, Kapolna B, Lugasi A. Functional food. Product development, marketing and consumer acceptance--a review. Appetite. 2008 Nov;51(3):456-67. doi: 10.1016/j.appet.2008.05.060. Epub 2008 Jun 4. — View Citation

Suskind DL, Wahbeh G, Burpee T, Cohen M, Christie D, Weber W. Tolerability of curcumin in pediatric inflammatory bowel disease: a forced-dose titration study. J Pediatr Gastroenterol Nutr. 2013 Mar;56(3):277-9. doi: 10.1097/MPG.0b013e318276977d. — View Citation

Tomaschunas M, Zorb R, Fischer J, Kohn E, Hinrichs J, Busch-Stockfisch M. Changes in sensory properties and consumer acceptance of reduced fat pork Lyon-style and liver sausages containing inulin and citrus fiber as fat replacers. Meat Sci. 2013 Nov;95(3):629-40. doi: 10.1016/j.meatsci.2013.06.002. Epub 2013 Jun 10. — View Citation

Wang SL, Li Y, Wen Y, Chen YF, Na LX, Li ST, Sun CH. Curcumin, a potential inhibitor of up-regulation of TNF-alpha and IL-6 induced by palmitate in 3T3-L1 adipocytes through NF-kappaB and JNK pathway. Biomed Environ Sci. 2009 Feb;22(1):32-9. doi: 10.1016/S0895-3988(09)60019-2. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loosing weight	Weight lost between basal and third month visits. Determined by a digital scale	Three months