Effects of MSPrebiotic on Gut Health in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 4
- 主要终点
- Inflammatory marker
研究概览
简要总结
The purpose of this clinical trial is to study the effects of potato resistant starch on the microbiota (microorganisms or bacteria) and short chain fatty acids levels of the gut. Levels will be measured and compared between elderly adults and in pre-elderly, adults from the general public. A correlation between the use of potato resistant starch and specific clinical and quality of life endpoints between elderly adults and in pre-elderly, adults from the general public will be studied.
Hypothesis 1: The investigator hypothesizes that the microbiome in elderly adults (≥70 years) is less diverse and more prone to imbalance compared to adults (30-50 years) from the general population and that this imbalance of the gut microflora in the elderly adults is partially related to inadequate RS in their diet.
Hypothesis 2: The investigator hypothesizes that ingestion of potato resistant starch of food grade quality (MSPrebiotic) will stabilize the gut microbiome (i.e. high Firmicutes/Bacteroides ratio)in LTC residents (i.e. similar to that of adults from the general population), thereby improving gut health and reducing the risk of diarrhea and/or gut infection.
详细描述
To assess the impact on the potato resistant starch on the microbiota, pyrosequencing will be performed on stool samples to determine the original composition and assess any changes over the study period. In addition the impact of the potato resistant starch on inflammatory markers will be assess through blood samples collected over the study period.
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
- •Willing to provide stool and blood specimens 5 times over the 14 week study period
- •Subjects ≥ 70 years of age
- •Subjects 30-50 years of age
排除标准
- •Pregnancy
- •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
- •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.
结局指标
主要结局
Inflammatory marker
时间窗: 2, 6, 10 and 14 weeks
Changes from baseline of Inflammatory marker (IL-10, C-reactive protein, TNFα) levels in blood at 2, 6, 10 and 14 weeks.
Gut health improvements
时间窗: 2, 6, 10 and 14 weeks
Changes from baseline in gut health improvements including: reduced constipation (i.e. improved ease of bowel movements without stool softeners), microbiome composition (i.e. favourable Firmicutes to Bacteroides ratio) at 2, 6, 10 and 14 weeks.
Tolerability of 30g dose of MSPrebiotic
时间窗: 2, 6, 10 and 14 weeks
Changes from baseline in the tolerability of ingestion of 30 g once/day of MSPrebiotic with respect to gastrointestinal side effects (excessive flatulence, changes in bowel movements, abdominal pain and bloating) at 2, 6, 10 and 14 weeks.
Levels of short chain fatty acids in stool and lipid level in blood
时间窗: 2, 4, 6, 10 and 14 weeks
Changes from baseline of short chain fatty acid levels in stool including; acetate, propionate, butyrate, isobutyrate, valerate, isovalerate at 2, 4, 6, 10 and 14 weeks.
次要结局
- Changes from baseline in overall health at 2, 6, 10 and 14 weeks(2, 6, 10 and 14 weeks)