Impact of Dietary Fiber as Prebiotics on Intestinal Microbiota in Obese Thai Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Abundance (Z-score) of Bifidobacterium at Baseline and Month 6
研究概览
简要总结
This study evaluates the changes in gut microbiota composition, body fat, children's eating behaviors, plasma amino acids, and satiety hormones (Peptide-YY and GLP-1) after a 6-month period in obese Thai children.
A total of 165 children, aged 7 to 15 years with a Body Mass Index (BMI) ≥ median + 2 standard deviation (SD), were randomized into three groups:
Group A (intervention group) received inulin daily.
Group B received an isocaloric maltodextrin placebo.
Group C received dietary fiber advice aimed to match age-appropriate recommendations.
详细描述
The prevalence of childhood obesity is increasing worldwide and is associated with gut microbiota dysbiosis, which affects energy regulation and systemic inflammation. Childhood obesity management typically involves lifestyle modifications, including dietary changes.
Prebiotics, such as inulin-type fructans, are non-digestible polysaccharides that can modulate the gut microbiota composition, specifically by stimulating the growth of beneficial bacteria like Bifidobacterium. This microbial shift may lead to the production of short-chain fatty acids (SCFAs), which play a role in host physiology and metabolic health.
This study aims to investigate the impact of inulin supplementation on the gut microbiota composition and various health parameters in obese Thai children. Participants were randomized into three groups:
Intervention group receiving inulin extracted from Thai Jerusalem artichoke.
Placebo group receiving isocaloric maltodextrin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children, age 7 to 15 years
- •Body mass index (BMI) ≥ median + 2 Standard deviation (SD)
排除标准
- •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
研究组 & 干预措施
Maltodextrin
Group B received isocaloric maltodextrin.
干预措施: Inulin (Dietary Supplement)
Dietary fiber
Group C will receive dietary fiber advice aimed to match age-appropriate intake recommendations.
干预措施: Inulin (Dietary Supplement)
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.
干预措施: Inulin (Dietary Supplement)
结局指标
主要结局
Abundance (Z-score) of Bifidobacterium at Baseline and Month 6
时间窗: Baseline and Month 6
The relative abundance of Bifidobacterium was determined using 16S rRNA gene sequencing from stool samples. The abundance values were then transformed into z-scores based on the distribution of the entire study population at baseline. A z-score of 0 represents the mean abundance of the population, while positive or negative values indicate the number of standard deviations above or below the mean, respectively.
Change from baseline in gut microbiota (16S rRNA sequencing) at 3 and 6 months
时间窗: From the enrollment to 3 months and the end of intervention at 6 months.
Gut microbial taxa, including Bifidobacterium, Blautia, Megasphaera, and several butyrate-producing bacteria, including Agathobacter, Eubacterium coprostanoligenes, and Subdoligranulum are being assessed.
次要结局
- Change from baseline in PYY hormone at 6 months(From enrollment to the end of intervention at 6 months.)
- Change From Baseline in Fat Mass Index (FMI) and Fat-Free Mass Index (FFMI) at 6 Months(From the enrollment to the end of intervention at 6 months.)
- Change From Baseline in Children's Eating Behaviors and at 6 Months(From the enrollment to the end of intervention at 6 months.)
- Change from baseline in Body mass index (BMI) at 1,2,3,4,5 and 6 months(From the enrollment to monthly visit and the end of intervention at 6 months.)
- Change from baseline in fat mass index (FMI) at 6 months(From the enrollment to 3 months and the end of intervention at 6 months.)
- Change from baseline in fecal short chain fatty acids (SCFAs) at 3 and 6 months(From the enrollment to 3 months and the end of intervention at 6 months.)
- Change from baseline in Inflammatory cytokines (ELISA method)(IL-1β, TNF-α and IL-6) at 6 months(From the enrollment to the end of intervention at 6 months.)
- Change from baseline in Children Eating Behaviors at 3 and 6 months(From the enrollment to 3 months and the end of intervention at 6 months.)
- Change from baseline in serum GLP-1 hormone at 6 months.(From enrollment to the end of intervention at 6 months)
- Change from baseline in myokine (interleukin-15) at 6 months(From enrollment to the end of intervention at 6 months.)
- Change from baseline in creatinine/cystatin C ratio at 6 months(From enrollment to the end of intervention at 6 months.)