Non-Pharmacologic Alternatives for Childhood Obesity

NCT03670875 | Completed

• 1 other identifier: R-2016-785-103
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity in Childhood

Keywords

Children, obesity, agave-inulin, curcumin, O3FA

Outcome Measures

Primary Outcomes (1)

• Loosing weight

  Weight lost between basal and third month visits. Determined by a digital scale

  Three months

Study Arms (4)

Agave inulin

EXPERIMENTAL

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

Curcumin

EXPERIMENTAL

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

Omega 3 Fatty Acids

EXPERIMENTAL

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

Control

OTHER

Recommendations to decrease calories intake an do exercise.

Behavioral: Control

Interventions

Agave inulin DIETARY_SUPPLEMENT

Will be provided in dehydrated apple cubes

Agave inulin

Curcumin DIETARY_SUPPLEMENT

Will be provided in capsules

Also known as: Turmeric

Curcumin

O3FA DIETARY_SUPPLEMENT

Will be provided in capsules

Omega 3 Fatty Acids

Control BEHAVIORAL

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)

Control

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

Biomedical Research Unit. IMSS. Durango

Durango, Durango, 34067, Mexico

Location

Related Publications (15)

• 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.

  PMID: 25797547 BACKGROUND

• 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.

  PMID: 18582508 BACKGROUND

• 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.

  PMID: 23811098 BACKGROUND

• 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.

  PMID: 17002459 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 24687355 BACKGROUND

• 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.

  PMID: 19462685 BACKGROUND

• 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.

  PMID: 23239418 BACKGROUND

• 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.

  PMID: 11040400 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 23059643 BACKGROUND

• 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.

  PMID: 14686961 BACKGROUND

• 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.

  PMID: 15481762 BACKGROUND

• 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.

  PMID: 23438101 BACKGROUND

• 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.

  PMID: 18602429 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Fernando Guerrero, PhD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

• Gerardo Martinez, PhD

  Instituto Mexicano del Seguro Social

  STUDY DIRECTOR

• Luis E Simental, PhD

  Instituto Mexicano del Seguro Social

  STUDY CHAIR

• Claudia I Gamboa, PhD

  Instituto Mexicano del Seguro Social

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the research unit

Model Details: 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)

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 14, 2018
• Study Start: July 31, 2021
• Primary Completion: October 31, 2022
• Study Completion: December 30, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)