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Trial record 37 of 592 for:    maltodextrin

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

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ClinicalTrials.gov Identifier: NCT03968003
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Chulalongkorn University

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Inulin Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Dietary Fiber as Prebiotics on Intestinal Microbiota in Obese Thai Children
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
Drug Information available for: Inulin

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 Name: 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 Name: 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 Name: Maltodextrin




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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))



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968003


Contacts
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Contact: Chonnikant Visuthranukul, M.D. 6622564903 deknet@gmail.com
Contact: Jaraspong Uaariyapanichkul, M.D. 6622564903 jaraspong_u@hotmail.com

Locations
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Thailand
Chulalongkorn University Recruiting
Bangkok, Thailand, 10330
Sub-Investigator: Chonnikant Visuthranukul, M.D.         
Sponsors and Collaborators
Chulalongkorn University
Investigators
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Principal Investigator: Chonnikant Visuthranukul, M.D. Chulalongkorn University

Publications of Results:
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Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT03968003     History of Changes
Other Study ID Numbers: 639/2017
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chulalongkorn University:
Prebiotics
Intestinal Microbiota