Study on Dietary Nutrition Intervention Techniques for Children Obesity

NCT02539836 | Completed

• 1 other identifier: COIF_001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

With the rapid development of society and economy, children's simple obesity is the rising in the world and has become a chronic disease which is one of the biggest public health challenges in the world. It is a serious threat to the health of children and their adulthood. The overweight and obesity is induced by the genetic and environmental factors. The environmental factors are very important, while the dietary factors are the driving factors of many chronic diseases including obesity. This study focus on the dietary intervention of childhood obesity to build healthy intestinal flora. The interventing food was based on a natural health food - fruit and vegetable fermentation liquid, and combined with other probiotic dietary factors, dietary fiber and oligosaccharides. The implementation of the study will help to reveal the fuction mechanism of intestinal bacteria in the obese children and normal children, and to construct healthy micro environment of intestinal flor. According to the positive effect factors, the study will propose a healthy diet and nutrition intervention model for obese children, which is significant to social health especially to children's health. To investigate the accuracy of MRI in quantifying liver fat with magnetic resonance spectroscopy (MRS) as a reference. A secondary goal was to assess the prevalence of nonalcoholic fatty liver disease in overweight and obese Chinese children and adolescents.

Conditions

Obesity; Intestinal Bacteria Flora Disturbance; Body Weight

Keywords

children's obesity; gut microbiome; body mass index; fruit and vegetable fermentation extraction; dietary nutrition intervention

Outcome Measures

Primary Outcomes (1)

• BMI change

  2 months

Secondary Outcomes (3)

• Serum biomarkers change

  2 months

• Weight loss

  2 months

• Gut microbiome profile change

  2 months

Study Arms (2)

Obesity with dietary nutrition

EXPERIMENTAL

Obese children will be intervented by dietary nutrition based on plant fermentation extract for 2 months.

Dietary Supplement: Dietary nutrition based on plant fermentation extract

Liver fat of obese children

ACTIVE COMPARATOR

To investigate the accuracy of MRI in quantifying liver fat with magnetic resonance spectroscopy (MRS) as a reference.

Diagnostic Test: MRI in quantifying liver fat with MRS

Interventions

Dietary nutrition based on plant fermentation extract DIETARY_SUPPLEMENT

The main ingredient of dietary nutrition is plant fermentation extraction which is from many fruit and vegetable fermented by probiotics.

Obesity with dietary nutrition

MRI in quantifying liver fat with MRS DIAGNOSTIC_TEST

To investigate the accuracy of MRI in quantifying liver fat with magnetic resonance spectroscopy (MRS) as a reference.

Liver fat of obese children

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• People whose BMI\>27 and Age between 15-18;the value of waistline/weight \>0.46; the value of body composition \>20%.

You may not qualify if:

• People treated by antibiotic drugs in 3 months;People with gastrointestinal diseases;People with Type I diabetes, any eating disorders such as bulimia or anorexia nervosa; Prader-Willi patients and obesity is part of clinical syndrome with other disorders.

Sponsors & Collaborators

• Chinese Academy of Sciences: lead
• Shenzhen Children's Hospital: collaborator

Study Sites (1)

Shenzhen Meilin High School

Shenzhen, Guangdong, 0755, China

Location

Related Publications (30)

• Tsiros MD, Coates AM, Howe PR, Grimshaw PN, Buckley JD. Obesity: the new childhood disability? Obes Rev. 2011 Jan;12(1):26-36. doi: 10.1111/j.1467-789X.2009.00706.x.

  PMID: 20070542 BACKGROUND

• Brien SE, Katzmarzyk PT. Physical activity and the metabolic syndrome in Canada. Appl Physiol Nutr Metab. 2006 Feb;31(1):40-7. doi: 10.1139/h05-024.

  PMID: 16604140 BACKGROUND

• Heitmann BL, Koplan J, Lissner L. Childhood obesity: successes and failures of preventive interventions. Nutr Rev. 2009 May;67 Suppl 1:S89-93. doi: 10.1111/j.1753-4887.2009.00167.x.

  PMID: 19453687 BACKGROUND

• Aranceta J, Moreno B, Moya M, Anadon A. Prevention of overweight and obesity from a public health perspective. Nutr Rev. 2009 May;67 Suppl 1:S83-8. doi: 10.1111/j.1753-4887.2009.00166.x.

  PMID: 19453686 BACKGROUND

• Ezzati M, Lopez AD, Rodgers A, Vander Hoorn S, Murray CJ; Comparative Risk Assessment Collaborating Group. Selected major risk factors and global and regional burden of disease. Lancet. 2002 Nov 2;360(9343):1347-60. doi: 10.1016/S0140-6736(02)11403-6.

  PMID: 12423980 BACKGROUND

• Xu H, Li Y, Liu A, Zhang Q, Hu X, Fang H, Li T, Guo H, Li Y, Xu G, Ma J, Du L, Ma G. Prevalence of the metabolic syndrome among children from six cities of China. BMC Public Health. 2012 Jan 6;12:13. doi: 10.1186/1471-2458-12-13.

  PMID: 22225617 BACKGROUND

• Whitaker RC, Wright JA, Pepe MS, Seidel KD, Dietz WH. Predicting obesity in young adulthood from childhood and parental obesity. N Engl J Med. 1997 Sep 25;337(13):869-73. doi: 10.1056/NEJM199709253371301.

  PMID: 9302300 BACKGROUND

• Musso G, Gambino R, Cassader M. Obesity, diabetes, and gut microbiota: the hygiene hypothesis expanded? Diabetes Care. 2010 Oct;33(10):2277-84. doi: 10.2337/dc10-0556.

  PMID: 20876708 BACKGROUND

• Smith JD, Montano Z, Dishion TJ, Shaw DS, Wilson MN. Preventing weight gain and obesity: indirect effects of the family check-up in early childhood. Prev Sci. 2015 Apr;16(3):408-19. doi: 10.1007/s11121-014-0505-z.

  PMID: 25263212 BACKGROUND

• Chaput JP, Despres JP, Bouchard C, Tremblay A. Longer sleep duration associates with lower adiposity gain in adult short sleepers. Int J Obes (Lond). 2012 May;36(5):752-6. doi: 10.1038/ijo.2011.110. Epub 2011 Jun 7.

  PMID: 21654631 BACKGROUND

• Zemel MB, Thompson W, Milstead A, Morris K, Campbell P. Calcium and dairy acceleration of weight and fat loss during energy restriction in obese adults. Obes Res. 2004 Apr;12(4):582-90. doi: 10.1038/oby.2004.67.

  PMID: 15090625 BACKGROUND

• Chaput JP, Leblanc C, Perusse L, Despres JP, Bouchard C, Tremblay A. Risk factors for adult overweight and obesity in the Quebec Family Study: have we been barking up the wrong tree? Obesity (Silver Spring). 2009 Oct;17(10):1964-70. doi: 10.1038/oby.2009.116. Epub 2009 Apr 9.

  PMID: 19360005 BACKGROUND

• Bervoets L, Van Hoorenbeeck K, Kortleven I, Van Noten C, Hens N, Vael C, Goossens H, Desager KN, Vankerckhoven V. Differences in gut microbiota composition between obese and lean children: a cross-sectional study. Gut Pathog. 2013 Apr 30;5(1):10. doi: 10.1186/1757-4749-5-10.

  PMID: 23631345 BACKGROUND

• Backhed F, Ding H, Wang T, Hooper LV, Koh GY, Nagy A, Semenkovich CF, Gordon JI. The gut microbiota as an environmental factor that regulates fat storage. Proc Natl Acad Sci U S A. 2004 Nov 2;101(44):15718-23. doi: 10.1073/pnas.0407076101. Epub 2004 Oct 25.

  PMID: 15505215 BACKGROUND

• Backhed F, Manchester JK, Semenkovich CF, Gordon JI. Mechanisms underlying the resistance to diet-induced obesity in germ-free mice. Proc Natl Acad Sci U S A. 2007 Jan 16;104(3):979-84. doi: 10.1073/pnas.0605374104. Epub 2007 Jan 8.

  PMID: 17210919 BACKGROUND

• Turnbaugh PJ, Gordon JI. The core gut microbiome, energy balance and obesity. J Physiol. 2009 Sep 1;587(Pt 17):4153-8. doi: 10.1113/jphysiol.2009.174136. Epub 2009 Jun 2.

  PMID: 19491241 BACKGROUND

• Turnbaugh PJ, Ley RE, Mahowald MA, Magrini V, Mardis ER, Gordon JI. An obesity-associated gut microbiome with increased capacity for energy harvest. Nature. 2006 Dec 21;444(7122):1027-31. doi: 10.1038/nature05414.

  PMID: 17183312 BACKGROUND

• Sanchez M, Panahi S, Tremblay A. Childhood obesity: a role for gut microbiota? Int J Environ Res Public Health. 2014 Dec 23;12(1):162-75. doi: 10.3390/ijerph120100162.

  PMID: 25546278 BACKGROUND

• Kadooka Y, Sato M, Imaizumi K, Ogawa A, Ikuyama K, Akai Y, Okano M, Kagoshima M, Tsuchida T. Regulation of abdominal adiposity by probiotics (Lactobacillus gasseri SBT2055) in adults with obese tendencies in a randomized controlled trial. Eur J Clin Nutr. 2010 Jun;64(6):636-43. doi: 10.1038/ejcn.2010.19. Epub 2010 Mar 10.

  PMID: 20216555 BACKGROUND

• Chang BJ, Park SU, Jang YS, Ko SH, Joo NM, Kim SI, Kim CH, Chang DK. Effect of functional yogurt NY-YP901 in improving the trait of metabolic syndrome. Eur J Clin Nutr. 2011 Nov;65(11):1250-5. doi: 10.1038/ejcn.2011.115. Epub 2011 Jun 22.

  PMID: 21697819 BACKGROUND

• Zarrati M, Salehi E, Nourijelyani K, Mofid V, Zadeh MJ, Najafi F, Ghaflati Z, Bidad K, Chamari M, Karimi M, Shidfar F. Effects of probiotic yogurt on fat distribution and gene expression of proinflammatory factors in peripheral blood mononuclear cells in overweight and obese people with or without weight-loss diet. J Am Coll Nutr. 2014;33(6):417-25. doi: 10.1080/07315724.2013.874937. Epub 2014 Jul 31.

  PMID: 25079040 BACKGROUND

• Kang JH, Yun SI, Park HO. Effects of Lactobacillus gasseri BNR17 on body weight and adipose tissue mass in diet-induced overweight rats. J Microbiol. 2010 Oct;48(5):712-4. doi: 10.1007/s12275-010-0363-8. Epub 2010 Nov 3.

  PMID: 21046354 BACKGROUND

• Piche T, des Varannes SB, Sacher-Huvelin S, Holst JJ, Cuber JC, Galmiche JP. Colonic fermentation influences lower esophageal sphincter function in gastroesophageal reflux disease. Gastroenterology. 2003 Apr;124(4):894-902. doi: 10.1053/gast.2003.50159.

  PMID: 12671885 BACKGROUND

• Cani PD, Bibiloni R, Knauf C, Waget A, Neyrinck AM, Delzenne NM, Burcelin R. Changes in gut microbiota control metabolic endotoxemia-induced inflammation in high-fat diet-induced obesity and diabetes in mice. Diabetes. 2008 Jun;57(6):1470-81. doi: 10.2337/db07-1403. Epub 2008 Feb 27.

  PMID: 18305141 BACKGROUND

• Cani PD, Delzenne NM. Interplay between obesity and associated metabolic disorders: new insights into the gut microbiota. Curr Opin Pharmacol. 2009 Dec;9(6):737-43. doi: 10.1016/j.coph.2009.06.016. Epub 2009 Jul 21.

  PMID: 19628432 BACKGROUND

• Cani PD, Delzenne NM. The gut microbiome as therapeutic target. Pharmacol Ther. 2011 May;130(2):202-12. doi: 10.1016/j.pharmthera.2011.01.012. Epub 2011 Feb 2.

  PMID: 21295072 BACKGROUND

• Pacifico L, Martino MD, Catalano C, Panebianco V, Bezzi M, Anania C, Chiesa C. T1-weighted dual-echo MRI for fat quantification in pediatric nonalcoholic fatty liver disease. World J Gastroenterol. 2011 Jul 7;17(25):3012-9. doi: 10.3748/wjg.v17.i25.3012.

  PMID: 21799647 BACKGROUND

• Schwimmer JB, Middleton MS, Behling C, Newton KP, Awai HI, Paiz MN, Lam J, Hooker JC, Hamilton G, Fontanesi J, Sirlin CB. Magnetic resonance imaging and liver histology as biomarkers of hepatic steatosis in children with nonalcoholic fatty liver disease. Hepatology. 2015 Jun;61(6):1887-95. doi: 10.1002/hep.27666. Epub 2015 Feb 5.

  PMID: 25529941 BACKGROUND

• Di Martino M, Pacifico L, Bezzi M, Di Miscio R, Sacconi B, Chiesa C, Catalano C. Comparison of magnetic resonance spectroscopy, proton density fat fraction and histological analysis in the quantification of liver steatosis in children and adolescents. World J Gastroenterol. 2016 Oct 21;22(39):8812-8819. doi: 10.3748/wjg.v22.i39.8812.

  PMID: 27818597 BACKGROUND

• Szczepaniak LS, Nurenberg P, Leonard D, Browning JD, Reingold JS, Grundy S, Hobbs HH, Dobbins RL. Magnetic resonance spectroscopy to measure hepatic triglyceride content: prevalence of hepatic steatosis in the general population. Am J Physiol Endocrinol Metab. 2005 Feb;288(2):E462-8. doi: 10.1152/ajpendo.00064.2004. Epub 2004 Aug 31.

  PMID: 15339742 BACKGROUND

MeSH Terms

Conditions

Obesity; Body Weight

Interventions

Magnetic Resonance Imaging; Positron-Emission Tomography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Image Enhancement; Photography; Radionuclide Imaging; Diagnostic Techniques, Radioisotope

Study Officials

• Yan Liang, Ph.D

  Shenzhen Institutes of Advanced Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research associate

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 3, 2015
• Study Start: September 1, 2015
• Primary Completion: December 30, 2016
• Study Completion: July 20, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

CN (1)