Impact of Dietary Fiber as Prebiotics on Intestinal Microbiota in Obese Thai Children
Condition: Obesity
Study type: Interventional

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.
    

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.
    

Intervention name(s): Inulin
Intervention type(s): Dietary Supplement
Intervention description(s): 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 intervention name(s): Maltodextrin
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
Keywords: Prebiotics; Intestinal Microbiota