The Effect of Synbiotic on Intestinal Microbiota and HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) on Obesity
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
研究概览
简要总结
Background :
There is a plausible relationship between microbial gut and insulin resistance. Intervention to prevent insulin resistance by modifying the microbial gut has been proposed but limited studies demonstrates the expected impact. One of the possible way to manipulate the microbial gut is the administration of synbiotic (prebiotic and probiotic).
Objective :
This study aim to address the impact of synbiotic administration to the microbial gut and insulin resistance.
Brief Methodology :
A Quasi Experimental study with multiple arms is conducted to healthy participants. All subjects will undergo a microbial gut taxonomic analysis using faecal sample and blood examination to determine the insulin resistance status (using Homeostatic Model Assessment for Insulin Resistance/HOMA-IR approach). Synbiotic will be given to intervention arm and active comparator will use maltodextrin. Repeated measurement will be conducted after 8 weeks and 12 weeks from the day of administration.
Hypothesis : A superiority trial hypothesis is applied, assuming that the synbiotic group will demonstrates higher variety of microbial gut and lower HOMA-IR level
详细描述
Study Location :
This study will recruit the healthy participants from the university
Target Population:
Healthy Participants
General Study Design :
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The participants receive the synbiotic in the form of fine powder and taken orally and packed with similar packages. Care provider (Research assistants) distribute the unlabeled formulation to the participants. Outcome assessors (laboratory technician) will not be informed regarding the allocation. Investigators are blinded from allocation and will not be informed until the final analysis. Only the statistician will perform and aware of the allocation. A propensity matching score (PSM) is preferred to allocate the participants.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age above 18 years old
- •Not receive antibiotic prescription within the last 6 months
- •Exclusion Criteria
- •Taking medication that alters the blood sugar
- •Taking probiotic or synbiotic product (such as yogurt)
- •Participant who do not take the synbiotic intervention for more than 3 days consecutively
- •incomplete follow up examination results
- •Develop adverse effect
排除标准
- 未提供
研究组 & 干预措施
Synbiotic
A fine powder to be taken orally consists of
Viable cell 1,0 x 10^9 Colony Forming Unit of :
- Lactobacillus plantarum 8,55 mg
- Streptococcus thermophilus 8,55 mg
- Bifidobacterium bifidum 2,55 mg
- Fructooligosaccharide 480 mg
- Additional components : isomalt, xylitol
干预措施: Synbiotic (Rillus) (Dietary Supplement)
Placebo
A powder of 5 gram maltodextrin is given as active comparator, taken orally.
干预措施: Placebo (Drug)
结局指标
主要结局
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
时间窗: Changes of HOMA IR value from baseline to 8 weeks
a value representing the insulin resistance yielded by multiplying the blood glucose value and insulin value, then divided by 405 (considering the unit of values are in mg/dL not mmol)
次要结局
未报告次要终点
研究者
Bumi Herman
Doctor
Hasanuddin University