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

August 7, 2021 updated by: Chulalongkorn University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inulin
Group A (intervention group) will receive inulin 10 g.
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-1β, TNF-α and IL-6) after 6-month studied period
Other Names:
  • Maltodextrin
Placebo Comparator: Maltodextrin
Group B will receive placebo of isocaloric maltodextrin.
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-1β, TNF-α and IL-6) after 6-month studied period
Other Names:
  • Maltodextrin
Active Comparator: Dietary fiber
Group C will receive dietary fiber advice aimed to match the recommended fiber intake for age.
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-1β, TNF-α and IL-6) after 6-month studied period
Other Names:
  • Maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut microbiota (16S rRNA sequencing)
Time Frame: Change from baseline in gut microbiota at 3 and 6 months
Relative abundant of gut microbiota phyla (focus on Firmicutes, Bacteroidetes, Proteobacteria, Actinobacteria)
Change from baseline in gut microbiota at 3 and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index (BMI)
Time Frame: Change from baseline in body mass index at 1,2,3,4,5 and 6 months
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
Short chain fatty acids
Time Frame: Change from baseline in acetate, propionate and butyrate at 3 months
Acetate, propionate and butyrate (By High Performance Liquid Chromatography)
Change from baseline in acetate, propionate and butyrate at 3 months
Inflammatory cytokines (ELISA method)(IL-1β, TNF-α and IL-6)
Time Frame: Change from baseline in inflammatory cytokines (ELISA)(IL-1β, TNF-α and IL-6) at 6 months
Inflammatory cytokine (ELISA method)(IL-1β(pg/ml), TNF-α (pg/ml) and IL-6(pg/ml))
Change from baseline in inflammatory cytokines (ELISA)(IL-1β, TNF-α and IL-6) at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Chonnikant Visuthranukul, M.D., Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

July 9, 2020

Study Registration Dates

First Submitted

May 9, 2019

First Submitted That Met QC Criteria

May 27, 2019

First Posted (Actual)

May 30, 2019

Study Record Updates

Last Update Posted (Actual)

August 13, 2021

Last Update Submitted That Met QC Criteria

August 7, 2021

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 639/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Informed Consent Form will be available to share with other researchers.

IPD Sharing Time Frame

Data will become available in 2022 and will share for 1 year.

IPD Sharing Access Criteria

Data will be made available upon request pending application and approval.

IPD Sharing Supporting Information Type

  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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