A Randomised, Double-blinded, Parallel Group, Placebo-Controlled Study to Evaluate the Effects of a Bioactive Peptide on Symptoms of Digestive Discomfort in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Digestive symptom frequency questionnaire
研究概览
简要总结
This trial will investigate the potential of a bioactive peptide to reduce symptoms of digestive discomfort in a generally healthy elderly population. Participants will consume the bioactive peptide for 12 weeks and various measures indicating an improvement in health and well being will be taken throughout the trial. It is believed that consumption of the study product will reduce the severity of digestive discomfort, reduce chronic inflammation, improve blood glucose metabolism and improve physical performance.
详细描述
Forty subjects aged between 65 and 75 with self-reported symptoms of digestive discomfort will be randomised. Subjects will be randomised to receive either the Bioactive peptide or placebo for a total of 12 weeks.
Subjects will undergo an initial phone screen and will be asked questions regarding their age and their symptoms of digestive discomfort. Eligible subjects will be scheduled for a screening visit. The study will involve 5 visits over a 13 to 16 week period.
At the screening visit (Visit 1) the inclusion and exclusion criteria will be reviewed and the overall details of the study will be explained and informed consent obtained. Vitals and Medical history, demographic data and concomitant medication will be recorded.
Subjects will be asked questions relating to their digestive symptoms, including symptoms of abdominal pain, discomfort, bloating and flatulence. Subjects will complete the Digestive Symptom Frequency Questionnaire (DSFQ), the International Physical Activity Questionnaire (IPAQ) and the Mini-mental State Exam (MMSE) will be administered. The Fried Frailty score will be completed and the Short Physical Performance Battery (SPPB) test will be performed. A fasting blood sample (9mls) will be collected and haematology, biochemistry, glucose and blood lipids will be measured.
Subjects will be provided with a stool collection kit and instructions for collecting and storing. Subjects will collect a stool sample at home, within 24 hours of their next visit and bring it to the clinic at their next visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be able to give written informed consent
- •Be between 65 and 75 years of age (inclusive)
- •Have symptoms of digestive pain & discomfort
- •Have a Fried Frailty score of <2
- •Have a Short physical performance battery (SPPB) score of >5 and <10
- •Have a Mini Mental State Exam (MMSE) score >24
- •Have low or moderate activity according to the IPAQ short form
- •Have a BMI <30 kg/m2
- •Be in good general health.
排除标准
- •Are less than 65 and greater than 75 years of age
- •Are severely immunocompromised (HIV positive, transplant Subject, on antirejection medications, on a steroid for >30 days.
- •Have a diagnosis of Irritable Bowel Syndrome
- •Is taking a high dose of statins and/or has changed had their dose modified in the previous 6 months
- •Is experiencing muscle pain, soreness or muscle loss in the previous 6 months
- •Has a history of drug and / or alcohol abuse at the time of enrolment
- •Has changed their dietary habit within the preceding month
- •Has a known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease
- •Subject currently involved in any other clinical trial or having participated in a trial within the preceding 90 days
- •Has known allergy to components of the test product
- •Use of anti-inflammatory steroid medications, anticoagulants, current/recent (3 months) history of anabolic steroid, corticosteroid or estrogen use, testosterone replacement therapy (ingestion, injection, or transdermal), or any anabolic steroid
- •Has any concurrent medical or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements
结局指标
主要结局
Digestive symptom frequency questionnaire
时间窗: Baseline (week 0) and end of treatment (week 12)
The primary endpoint is the difference between the change experienced over 12 weeks in the active group versus the change in the placebo group using the digestive symptom frequency questionnaire (DSFQ) at baseline and end of treatment
次要结局
- To determine the effect of supplementation of a Bioactive Peptide on upper body muscle strength(Baseline (weeks 0) and week 4, week 8 and week 12)
- To determine the effect of supplementation of a Bioactive Peptide on physical performance(Baseline (weeks 0) and week 12)
- To determine the effect of supplementation of a Bioactive Peptide on blood glucose(Baseline (weeks 0) and week 12)
- To determine the effect of supplementation of a Bioactive Peptide on muscle mass(Baseline (week 0) and week 12)
- To determine the effect of supplementation of a Bioactive Peptide on lower body muscle strength(Baseline (weeks 0) and week 4, week 8 and week 12)
- To determine the effect of supplementation of a Bioactive Peptide on blood markers of inflammation(Baseline (weeks 0) and week 4, week 8 and week 12)
- To determine the effect of supplementation of a Bioactive Peptide on blood lipid(Baseline (weeks 0) and week 4, week 8 and week 12)