Effect of MSPrebiotic Digestion Resistant Starch on Gastrointestinal Function and Blood Glucose Levels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Changes from baseline in bowel movements with respect to number of bowel movements and stool consistency
研究概览
简要总结
The objective of the study is to investigate the impact of daily consumption of MSPrebiotic at a dosage level of 30 g per day for 12 weeks on gastrointestinal microbiota in the elderly (> 70 years age) and another age group (30 to 50 years). In addition, impact of MSPrebiotic on short chain fatty acids, glucose and insulin levels as well as metabolomic changes will also be studied. A randomized, double-blinded study will be conducted to assess the health benefits of MSPrebiotic and compared with a placebo. This study will provide substantiation for a beneficial effect of MSPrebiotic resistant starch on gut microbiome.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to provide written informed consent (or by the authorized 3rd party).
- •Willing to provide stool (2 times) and blood (6 times) samples over the 14 week study period
- •Subjects between 30-50 and above 70 years of age
- •Subjects willing to provide fasting blood during Screening and weeks 0, 2, 6, 10 and 14 visits
- •Female subjects not pregnant or breast feeding
- •Female subjects not planning for pregnancy during the study period
排除标准
- •Crohn's disease or any other inflammatory bowel disease
- •Individuals with Lupus, or on cancer chemotherapy
- •Pre-diabetes or Diabetes
- •Thyroid disease
- •Renal disease
- •Hepatic disease
- •Previous gastrointestinal surgery (intestinal resection, gastric bypass, colorectal surgery)
- •Subjects on probiotic (e.g. yoghurt),
- •Subjects on antibiotics at time of recruitment or on antibiotics within the previous five weeks
- •Individuals experiencing dysphagia
- •Subjects using additional fiber supplements
- •Subjects on digestants, emetics and antiemetics, medications for acid peptic disease and antacids.
- •Subjects allergic to potato or corn
- •Have conditions, factors, medication (other than those listed above) that the Investigator believes may affect the response of the gut or the interpretation of the test results
结局指标
主要结局
Changes from baseline in bowel movements with respect to number of bowel movements and stool consistency
时间窗: 0, 2, 6,10 and 14 weeks
Number of bowel movements will be measured using questionnaire. Stool consistency will be measured using questionnaires recording Bristol score. Bristol stool chart indicates the following types: Type 1-Separate hard lumps, like nuts; Type 2-Sausage-shaped but lumpy; Type 3-Like a sausage but with cracks on its surface; Type 4-Like a sausage or snake, smooth and soft; Type 5-Soft blobs with clear-cut edges (passed easily); Type 6-Fluffy pieces with ragged edges, a mushy stool; Type 7-Watery, no solid pieces. Entirely liquid.
Changes from baseline in blood glucose concentrations
时间窗: 0, 2, 6,10 and 14 weeks
Blood glucose levels concentrations will be measured using standard laboratory methods
Changes from baseline in blood insulin concentrations
时间窗: 0 and 14 weeks
Blood insulin concentrations will be measured using standard laboratory methods
Changes from baseline in gut microbiome
时间窗: 0 and 14 weeks
Gut microbiome composition (ratio between number of Firmicutes and Bacteroides) will be measured using 16S ribosomal ribonucleic acid (rRNA) gene sequencing in stool samples
Changes from baseline in concentration of short chain fatty acids in stool samples
时间窗: 0 and 14 weeks
Concentration of short chain fatty acids (acetate, propionate, butyrate, isobutyrate, valerate,isovalerate) in feces will be measured using gas chromatographic method
次要结局
- Changes from baseline in concentration of blood lipids and C-reactive protein Inflammatory marker C-reactive protein. Metabolomic changes(0 and14 weeks)
- Changes from baseline in concentration of blood and fecal Metabolomics(0 and 14 weeks)
- Changes from baseline in tolerability in terms of excessive flatulence, abdominal pain, and bloating: questionnaires(0, 2, 6,10 and 14 weeks)
- Changes from baseline in overall health in terms of outpatient visits and hospitalizations(0, 2, 6,10 and 14 weeks)