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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2020-07-09

Brief Summary

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This study evaluates the changes of gut microbiota composition and diversity, gut-muscle axis, body weight, body fat, children eating behaviours, SCFAs, plasma amino acids, satiety hormones (Peptide-YY(PYY) and glucagon-like peptide 1(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.

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Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Inulin

Group A consumed 10 g of inulin extracted from Thai Jerusalem artichoke by our patent technique (Patent no. 15858) administered once daily before dinner.

Group Type EXPERIMENTAL

Inulin

Intervention Type DIETARY_SUPPLEMENT

The intervention group (group A) consumed 10 g of inulin extracted from Thai Jerusalem artichoke by our patent technique (Patent no. 15858) administered once daily before dinner. The placebo group (group B) received isocaloric maltodextrin, while the dietary fiber advice group (group C) received guidance based on age-appropriate intake recommendations.

Maltodextrin

Group B received isocaloric maltodextrin.

Group Type PLACEBO_COMPARATOR

Inulin

Intervention Type DIETARY_SUPPLEMENT

The intervention group (group A) consumed 10 g of inulin extracted from Thai Jerusalem artichoke by our patent technique (Patent no. 15858) administered once daily before dinner. The placebo group (group B) received isocaloric maltodextrin, while the dietary fiber advice group (group C) received guidance based on age-appropriate intake recommendations.

Dietary fiber

Group C will receive dietary fiber advice aimed to match age-appropriate intake recommendations.

Group Type ACTIVE_COMPARATOR

Inulin

Intervention Type DIETARY_SUPPLEMENT

The intervention group (group A) consumed 10 g of inulin extracted from Thai Jerusalem artichoke by our patent technique (Patent no. 15858) administered once daily before dinner. The placebo group (group B) received isocaloric maltodextrin, while the dietary fiber advice group (group C) received guidance based on age-appropriate intake recommendations.

Interventions

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Inulin

The intervention group (group A) consumed 10 g of inulin extracted from Thai Jerusalem artichoke by our patent technique (Patent no. 15858) administered once daily before dinner. The placebo group (group B) received isocaloric maltodextrin, while the dietary fiber advice group (group C) received guidance based on age-appropriate intake recommendations.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Maltodextrin

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes