Nutritional Intake and Gut Microbiome

NCT03388411 | Completed

• 1 other identifier: Gut microbiome
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Pediatric obesity has been increasing in prevalence, but concerns have been raised around the world because no treatment has been found. Recently, however, research on gut microbiome has begun to become a new alternative. It has been shown that changes in the microbiome in adults may induce obesity. However, the results on children are still scarce. Unlike adults, children have few external factors such as alcohol, tobacco, stress, and cancer, making them suitable for obesity-related gut microbiome studies. The investigators will use Illumina MiSeq platform for 16s rRNA metagenomics profiling in children. In this study, the investigators aimed to analyze the relationship between pediatric obesity, gut microbiome profile, blood biomarkers relevant to metabolic syndrome, and nutrient intake data.

Conditions

Obesity, Childhood

Keywords

Microbiome; Gut

Outcome Measures

Primary Outcomes (2)

• Correlation of fecal microbial profile with childhood obesity

  Analysis of fecal microbial profile using 16s rRNA sequencing

  visit 1day

• Correlation of fecal microbial profile with nutrient intake data using feeding diary

  Nutritional intake analysis of total calorie, carbohydrate, fiber, fat, and protein from feeding dairy for two days

  visit 1day

Secondary Outcomes (1)

• Correlation of childhood obesity with metabolic abnomalities using blood sampling

  visit 1day

Study Arms (2)

Obese children

Children ≥95 ‰ between age 7 and 12 years

Diagnostic Test: Gut microbiome profiling

Non-obese children

5‰\< BMI \<85 ‰ for children between the ages of 7 and 12 years

Diagnostic Test: Gut microbiome profiling

Interventions

Gut microbiome profiling DIAGNOSTIC_TEST

Gut microbial profiling will be done with next-generation sequencing targeting bacterial 16s rRNA genes.

Also known as: 16s metagenomic analysis

Non-obese children; Obese children

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic and community samples

You may qualify if:

• Obese children: Children ≥95 ‰ between age 7 and 12 years
• Non-obese children: 5‰\<BMI \<85 ‰ for children between the ages of 7 and 12 years

You may not qualify if:

• Taking antibiotics, probiotics, or steroids for a month before visit
• Taking probiotics-like products including yogurt for seven days before visit
• Having enteritis symptoms including diarrhea for a month before visit
• Chronic heart disease, chronic bowel disease, chronic liver disease, chronic kidney disease, endocrine disease, genetic diseases or congenital metabolic disorder

Sponsors & Collaborators

• Hallym University Kangnam Sacred Heart Hospital: lead

Study Sites (1)

Hallym University Kangnam Sacred Heart Hospital

Seoul, 07440, South Korea

Location

Related Publications (13)

• Clemente JC, Ursell LK, Parfrey LW, Knight R. The impact of the gut microbiota on human health: an integrative view. Cell. 2012 Mar 16;148(6):1258-70. doi: 10.1016/j.cell.2012.01.035.

  PMID: 22424233 BACKGROUND

• Qin J, Li R, Raes J, Arumugam M, Burgdorf KS, Manichanh C, Nielsen T, Pons N, Levenez F, Yamada T, Mende DR, Li J, Xu J, Li S, Li D, Cao J, Wang B, Liang H, Zheng H, Xie Y, Tap J, Lepage P, Bertalan M, Batto JM, Hansen T, Le Paslier D, Linneberg A, Nielsen HB, Pelletier E, Renault P, Sicheritz-Ponten T, Turner K, Zhu H, Yu C, Li S, Jian M, Zhou Y, Li Y, Zhang X, Li S, Qin N, Yang H, Wang J, Brunak S, Dore J, Guarner F, Kristiansen K, Pedersen O, Parkhill J, Weissenbach J; MetaHIT Consortium; Bork P, Ehrlich SD, Wang J. A human gut microbial gene catalogue established by metagenomic sequencing. Nature. 2010 Mar 4;464(7285):59-65. doi: 10.1038/nature08821.

  PMID: 20203603 BACKGROUND

• Eckburg PB, Bik EM, Bernstein CN, Purdom E, Dethlefsen L, Sargent M, Gill SR, Nelson KE, Relman DA. Diversity of the human intestinal microbial flora. Science. 2005 Jun 10;308(5728):1635-8. doi: 10.1126/science.1110591. Epub 2005 Apr 14.

  PMID: 15831718 BACKGROUND

• Yun Y, Kim HN, Kim SE, Heo SG, Chang Y, Ryu S, Shin H, Kim HL. Comparative analysis of gut microbiota associated with body mass index in a large Korean cohort. BMC Microbiol. 2017 Jul 4;17(1):151. doi: 10.1186/s12866-017-1052-0.

  PMID: 28676106 BACKGROUND

• David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11.

  PMID: 24336217 BACKGROUND

• Hu HJ, Park SG, Jang HB, Choi MK, Park KH, Kang JH, Park SI, Lee HJ, Cho SH. Obesity Alters the Microbial Community Profile in Korean Adolescents. PLoS One. 2015 Jul 31;10(7):e0134333. doi: 10.1371/journal.pone.0134333. eCollection 2015.

  PMID: 26230509 BACKGROUND

• Cox AJ, West NP, Cripps AW. Obesity, inflammation, and the gut microbiota. Lancet Diabetes Endocrinol. 2015 Mar;3(3):207-15. doi: 10.1016/S2213-8587(14)70134-2. Epub 2014 Jul 22.

  PMID: 25066177 BACKGROUND

• Schwiertz A, Taras D, Schafer K, Beijer S, Bos NA, Donus C, Hardt PD. Microbiota and SCFA in lean and overweight healthy subjects. Obesity (Silver Spring). 2010 Jan;18(1):190-5. doi: 10.1038/oby.2009.167. Epub 2009 Jun 4.

  PMID: 19498350 BACKGROUND

• Turnbaugh PJ, Backhed F, Fulton L, Gordon JI. Diet-induced obesity is linked to marked but reversible alterations in the mouse distal gut microbiome. Cell Host Microbe. 2008 Apr 17;3(4):213-23. doi: 10.1016/j.chom.2008.02.015.

  PMID: 18407065 BACKGROUND

• Jumpertz R, Le DS, Turnbaugh PJ, Trinidad C, Bogardus C, Gordon JI, Krakoff J. Energy-balance studies reveal associations between gut microbes, caloric load, and nutrient absorption in humans. Am J Clin Nutr. 2011 Jul;94(1):58-65. doi: 10.3945/ajcn.110.010132. Epub 2011 May 4.

  PMID: 21543530 BACKGROUND

• Pedersen HK, Gudmundsdottir V, Nielsen HB, Hyotylainen T, Nielsen T, Jensen BA, Forslund K, Hildebrand F, Prifti E, Falony G, Le Chatelier E, Levenez F, Dore J, Mattila I, Plichta DR, Poho P, Hellgren LI, Arumugam M, Sunagawa S, Vieira-Silva S, Jorgensen T, Holm JB, Trost K; MetaHIT Consortium; Kristiansen K, Brix S, Raes J, Wang J, Hansen T, Bork P, Brunak S, Oresic M, Ehrlich SD, Pedersen O. Human gut microbes impact host serum metabolome and insulin sensitivity. Nature. 2016 Jul 21;535(7612):376-81. doi: 10.1038/nature18646. Epub 2016 Jul 13.

  PMID: 27409811 BACKGROUND

• Yoo JY, Kim SS. Probiotics and Prebiotics: Present Status and Future Perspectives on Metabolic Disorders. Nutrients. 2016 Mar 18;8(3):173. doi: 10.3390/nu8030173.

  PMID: 26999199 BACKGROUND

• Fadrosh DW, Ma B, Gajer P, Sengamalay N, Ott S, Brotman RM, Ravel J. An improved dual-indexing approach for multiplexed 16S rRNA gene sequencing on the Illumina MiSeq platform. Microbiome. 2014 Feb 24;2(1):6. doi: 10.1186/2049-2618-2-6.

  PMID: 24558975 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, stool

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Ky Young Cho, M.D.

  Kangnam Sacred Heart Hospital, Hallym University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: January 3, 2018
• Study Start: October 18, 2017
• Primary Completion: October 12, 2018
• Study Completion: October 12, 2018
• Last Updated: February 27, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)