The Effect of Pectin Supplementation on Geriatric With Frailty: A Randomised Placebo-Controlled Dietary Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in microbiome profile
研究概览
简要总结
The study involves the intake of Low-methoxy (LM) pectin (polysaccharides extracted from citrus peels), which are commonly found in the UK diet (not pharmacological agents), to test their effects on systematic inflammation in the body and gut microbiome composition. Study subjects will be healthy elderly with early signs of frailty or pre-frailty from the local population and will be asked to attend the laboratory on 2 occasions; before and after 4-week' supplementing the diet daily with either 10g of pectin with 10g of whey protein and 10g of cocoa powder added as flavour (active arm) or 10g of whey protein with 10g of cocoa powder added as flavour (placebo). Participants will be given the blinded products portioned in individual sachets, with instructions to add the contents of one sachet a day to 150ml of milk and to consume immediately.
At each study visit (~90 minutes), participants will be asked to provide a stool and blood sample, will have blood pressure, heart rate, weight, height, and waist/hip ratio measured, research team will perform physical functioning test (Time up and go test, 30-second sit to stand test) as well as participants will complete the quality-of-life questionnaire (SF-36), the Depression and Anxiety (HADS) and the Gastrointestinal Symptom Rating Scale (GSRS).
详细描述
The overall aim of the proposed project is to study the effect of daily ingestion of a dietary fibre (LM pectin) among frail population on anti-inflammatory and cardioprotective metabolic measures and to determine whether effects are mediated via the modulation of the gut microbiome and SCFAs production.
Specific Aim 1: To determine the effects of 4-weeks' pectin dietary supplementation on gut microbiome composition and diversity and the concentration of markers of intestinal permeability in the blood.
Specific Aim 2: To investigate the impact of daily pectin intake on physical functioning and subjective quality of life.
Specific Aim 3: To investigate the consequences of 4-weeks' daily ingestion of pectin on subjective measures of depression and anxiety among frail participants.
30 healthy elderly with early signs of frailty or pre-frailty will be recruited following a successful medical screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blinded.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Participant eligibility includes those aged >65 years who have a body mass index (BMI) between 18.5 and 39.9 kg/m
- •Participants who are considered as pre-frail or frail based on FRAIL (Simple Frailty Questionnaire).
排除标准
- •Have gastrointestinal conditions e.g. malabsorptive conditions such as IBS/IBD, coeliac or functional conditions such as gastroparesis or food intolerances etc.
- •History of major surgery which potentially limit participation or completion of the study.
- •History of gastrointestinal resection surgery, including bariatric surgery.
- •Used of antibiotics, antifungal medications, probiotics or prebiotics 90 days before the start of the study.
- •Are taking the following medications: immunosuppressants, amiodarone and/or perhexiline.
- •Are currently following or anticipated to commence a specialised commercially available weight loss diet and/or program.
- •History of side effects towards probiotics or prebiotics.
- •History or current psychiatric illness.
- •History or current neurological condition (e.g. epilepsy).
- •Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance.
研究组 & 干预措施
Whey protein
10g of whey protein with 10g of cocoa powder added as flavour will be provided to participants for 4 weeks.
干预措施: Whey protein (Other)
Pectin
10g of pectin with 10g of whey protein and 10g of cocoa powder added as flavour will be provided to participants for 4 weeks.
干预措施: Pectin (Dietary Supplement)
结局指标
主要结局
Change in microbiome profile
时间窗: 4 weeks
Change in microbiome profile, assessed using 16s RNA sequencing analysis of faecal samples provided pre and post the 4-week intervention period.
Change in inflammatory profile
时间窗: 4 weeks
Change in circulating markers of inflammation measured by ELISAs in serum samples collected pre and post the 4-week intervention period.
Changes in short chain fatty acids (SCFAs)
时间窗: 4 weeks
Change in serum SCFAs measured by mass spectrometry pre and post the 4-week intervention period.
次要结局
- Change in waist-to-hip ratio (WHR)(4 weeks)
- Change in time up and go test (TUG)(4 weeks)
- Change in 30-second sit to stand test(4 weeks)
- Change in systolic blood pressure (lying to standing) pre intervention(4 minutes)
- Change in systolic blood pressure (lying to standing) post intervention(4 minutes)
- Change in diastolic blood pressure (lying to standing) pre intervention(4 minutes)
- Change in diastolic blood pressure (lying to standing) post intervention(4 minutes)
- Change in body mass index (BMI)(4 weeks)
- Change in Hospital Anxiety and Depression Score (HADS)(4 weeks)
- Change in 36-Item Short Form Survey (SF-36) Questionnaire(4 weeks)
研究者
Ana Valdes
Professor in Genetic and Molecular Epidemiology
University of Nottingham