Impact of Dietary Fiber as Prebiotics on Intestinal Microbiota in Obese Thai Children

Obesity Clinical Trial

Official title:

Impact of Dietary Fiber as Prebiotics on Intestinal Microbiota in Obese Thai Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03968003
• Other study ID #: 639/2017
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: July 9, 2020

Study information

• Verified date: July 2020
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the changes of gut microbiota composition and diversity, body weight, body fat, SCFAs, plasma amino acids, satiety hormones (Peptide-YY(PYY) and glucagon-like peptide(GLP-1)), Inflammatory cytokines (Interleukin-1β(IL-1β), Tumor necrosis factor-α (TNF-α) and Interleukin-6(IL-6)) after 6-month studied period in obese Thai children.165 participants Children, age 7 to 15 years with Body mass index (BMI) ≥ median + 2 standard deviation(SD) will be randomized into one of the three arms of 55 participants per group.Group A (intervention group) will receive inulin 10 g.Group B will receive placebo of isocaloric maltodextrin. Group C will receive dietary fiber advice aimed to match the recommended fiber intake for age.

Description:

The prevalence of childhood obesity is increasing worldwide. The prevalence of overweight and obesity in children and adolescents has risen dramatically from 4% to 18% in 40 years.

Cause of obesity is gene-environment interactions. Recent evidence suggests that the gut microbiota is involved in energy regulation as well as inflammation Definition of obesity for children and teens is defined as a BMI at or above median +2 standard deviation(SD) of the same age and sex from World Health Organization (WHO) reference Management of childhood obesity are therapeutic lifestyle change by changing dietary habits and the physical activity level. Consumption of prebiotics, which are non-digestible polysaccharides that utilized by gut microorganisms then microbial shifts in response to prebiotic intake change in Bifidobacterium and lead to decreased body weight and adiposity. The microbial metabolite short-chain fatty acids (SCFAs) are likely to have impacts on various aspects of host physiology and then may decrease in body weight and adiposity.

The mechanism of inflammation in obesity, Lipopolysaccharides (LPS) which derived from the outer cell membrane of Gram-negative bacteria are the trigger factor of inflammation.LPS cross the gastrointestinal mucosa, then they reach the systemic circulation and trigger innate immune response activate the maturation of IL-1β. Circulating LPS levels were associated with elevated TNF-α and IL-6 concentrations in adipocytes.

Inulin-type fructans are non-digestible, fully soluble, and fermentable food ingredients with known prebiotic properties, which are found naturally in chicory root and Jerusalem artichoke, a plant grown in Thailand, that are fermented in the colon to produce SCFA. Bifidobacteria are preferentially stimulated to grow, by increasing the number of health-promoting bacteria and reducing the number of potentially harmful species.

There was only one study about the effect of prebiotics on composition of the intestinal microbiota in children with overweight or obesity. The study performed a randomized controlled trial to study children, 7-12 years old, with overweight or obesity. Participants were randomly assigned to groups given either oligofructose-enriched inulin (OI; 8 g/day; n = 22) or maltodextrin placebo (isocaloric dose, controls; n = 20) once daily for 16 weeks. Fecal samples were collected at baseline and 16 weeks and the composition of the microbiota was analyzed by 16S ribosomal ribonucleic acid (rRNA) sequencing and qPCR. The primary outcome was change in percent body fat from baseline to 16 weeks. After 16 weeks, quantitative polymerase chain reaction(qPCR) showed a significant increase in Bifidobacterium spp. in the OI group compared with controls. 16S rRNA sequencing revealed significant increases in species of the genus Bifidobacterium and decreases in Bacteroides vulgatus within the group who consumed OI.children who consumed OI had significant decreases in body weight z-score (decrease of 3.1%), percent body fat (decrease of 2.4%), percent trunk fat (decrease of 3.8%), interleukin 6 from baseline (decrease of 15%) compared with children given placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: July 9, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 15 Years

Eligibility

Inclusion Criteria:

• Children, age 7 to 15 years

• Body mass index (BMI) = median + 2 Standard deviation (SD)

Exclusion Criteria:

• Underlying disease of syndromic obesity and monogenic obesity

• Endocrine causes of obesity (e.g. hypothyroidism, growth hormone deficiency)

• Use of drugs that influence appetite or body weight (e.g. corticosteroids)

• Attending other concurrent weight reduction programs

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Inulin
Group A (intervention group) will receive inulin 10 g.Group B will receive placebo of isocaloric maltodextrin. Group C will receive dietary fiber advice aimed to match the recommended fiber intake for age.This study evaluates the changes of gut microbiota composition and diversity, body weight, body fat, SCFAs, plasma amino acids, satiety hormones (PYY and GLP-1), Inflammatory cytokines (IL-1ß, TNF-a and IL-6) after 6-month studied period

Locations

Country	Name	City	State
Thailand	Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (7)

Boulangé CL, Neves AL, Chilloux J, Nicholson JK, Dumas ME. Impact of the gut microbiota on inflammation, obesity, and metabolic disease. Genome Med. 2016 Apr 20;8(1):42. doi: 10.1186/s13073-016-0303-2. Review. — View Citation

de Onis M, Blössner M, Borghi E. Global prevalence and trends of overweight and obesity among preschool children. Am J Clin Nutr. 2010 Nov;92(5):1257-64. doi: 10.3945/ajcn.2010.29786. Epub 2010 Sep 22. — View Citation

Ferrer M, Ruiz A, Lanza F, Haange SB, Oberbach A, Till H, Bargiela R, Campoy C, Segura MT, Richter M, von Bergen M, Seifert J, Suarez A. Microbiota from the distal guts of lean and obese adolescents exhibit partial functional redundancy besides clear diff — View Citation

Maffeis C. Aetiology of overweight and obesity in children and adolescents. Eur J Pediatr. 2000 Sep;159 Suppl 1:S35-44. Review. — View Citation

Nicolucci AC, Hume MP, Martínez I, Mayengbam S, Walter J, Reimer RA. Prebiotics Reduce Body Fat and Alter Intestinal Microbiota in Children Who Are Overweight or With Obesity. Gastroenterology. 2017 Sep;153(3):711-722. doi: 10.1053/j.gastro.2017.05.055. E — View Citation

Niness KR. Inulin and oligofructose: what are they? J Nutr. 1999 Jul;129(7 Suppl):1402S-6S. doi: 10.1093/jn/129.7.1402S. Review. — View Citation

WHO Multicentre Growth Reference Study Group. WHO Child Growth Standards based on length/height, weight and age. Acta Paediatr Suppl. 2006 Apr;450:76-85. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut microbiota (16S rRNA sequencing)	Relative abundant of gut microbiota phyla (focus on Firmicutes, Bacteroidetes, Proteobacteria, Actinobacteria)	Change from baseline in gut microbiota at 3 and 6 months
Secondary	Body mass index (BMI)	Weight in kilograms and height in meters will be combined to report BMI in kg/m^2	Change from baseline in body mass index at 1,2,3,4,5 and 6 months
Secondary	Short chain fatty acids	Acetate, propionate and butyrate (By High Performance Liquid Chromatography)	Change from baseline in acetate, propionate and butyrate at 3 months
Secondary	Inflammatory cytokines (ELISA method)(IL-1ß, TNF-a and IL-6)	Inflammatory cytokine (ELISA method)(IL-1ß(pg/ml), TNF-a (pg/ml) and IL-6(pg/ml))	Change from baseline in inflammatory cytokines (ELISA)(IL-1ß, TNF-a and IL-6) at 6 months