Effects of Plant Foods on Gastrointestinal and Cardiometabolic Health (PLANTIFUL)
A Randomised Controlled Trial Investigating the Impact of Plant Foods on Gastrointestinal and Cardiometabolic Health
The aim of this randomised controlled trial is to investigate the effects of plant foods on gastrointestinal and cardiometabolic health in healthy adults aged 30-70 years old. The main question it will answer is "what is the effect of plant foods on alpha-diversity of the gut microbiota?".
Researchers will compare two diets containing plant foods to see if they have different effects on gastrointestinal and cardiometabolic health.
Participants will be asked to replace all their meals, snacks and drinks with those provided by the study team for four weeks (6 days/week). Participants will also be asked to attend the research facility on three occasions to:
- Provide a blood sample
- Provide a urine sample
- Provide a stool sample
- Have their body composition assessed
- Have an ultrasound of their artery (arm)
- Have their blood pressure measured
- Answer questionnaires related to dietary intake, mental health, physical activity, quality of life, diet acceptability and adherence
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
London、英国、SE1 9NH
- 招聘中
- King's College London
-
接触:
- Clinical Trial Manager
- 电话号码:+442078484552
- 邮箱:plantiful@kcl.ac.uk
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Adults aged 30-70 years of age
- Capacity to give informed consent in English
- Consume equal or less than the average UK plant food intake (number and quantity)
- Consume less than 30 g/d of fibre
- BMI 18.50-29.99 kg/m2
- Willing to complete the trial by adhering to the diet intervention, complete questionnaires, provide stool, urine and blood samples, record weight and other anthropometric values and record food intake throughout the study
- Willing and able to adhere to the protocol for the diet intervention for the whole duration of the trial (e.g., appropriate space in freezer to store meals, access to oven/microwave, no planned travelling)
- Willing to discontinue use of prebiotics and probiotics 4 weeks prior and during the intervention period
- Willing to consume animal products daily
- Medication use is stable in women receiving hormone replacement therapy (stable use for the past 3 months)
Exclusion Criteria:
- Medical history of any of the following: diabetes, major active or historic psychiatric conditions (e.g., schizophrenia), current eating disorder, alcohol abuse, active treatment for cancer in the last year, severe neurological, endocrine, renal, cardiac or pulmonary disease (or any other chronic medical condition), severe oesophagitis, gastritis or duodenitis, active diverticulitis or intestinal/colonic strictures, Coeliac disease, Crohn's disease or Ulcerative colitis, stem cell or organ transplant, gut resection surgery (excluding appendicectomy and cholecystectomy), bleeding disorder, anaphylaxis or any other major or chronic condition known to impact study outcome measures.
- A current diagnosis of IBS, as defined by the Rome IV criteria.
- Taking medications known to affect outcomes of interest, including:
- Prebiotics and probiotics 4 weeks prior to enrolment.
- Antibiotics within 4 weeks of enrolment.
- Medications known to affect blood pressure, appetite, gut motility, glucose control, or lipid levels within 4 weeks of enrolment.
- Taking any dietary supplements, apart from vitamin D or calcium supplements, 4 weeks prior to enrolment.
- Allergy or intolerance to any study food ingredients.
- Unable/dislike/unwilling to consume study foods or adhere to study protocol (e.g., not willing to drink a maximum 9 units of alcohol a week or consume animal products).
- Currently reported pregnant or lactating.
- Unwilling or unable to consume non-halal or non-kosher products.
- Estimated energy requirements of <1,500 kcal/day or >3,000 kcal/day.
- Unexplained or unintentional weight loss in the past six months.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Study Diet A
Meals, snacks and drinks that contain plant foods provided by the research team for four weeks (6 days a week).
|
Study meals, snacks and drinks will be provided that contain plant foods for four weeks (6 days a week).
Participants will follow guidance in self-selecting foods on one day per week.
其他名称:
|
|
有源比较器:Study Diet B
Meals, snacks and drinks that contain plant foods provided by the research team for four weeks (6 days a week).
|
Study meals, snacks and drinks will be provided that contain plant foods for four weeks (6 days a week).
Participants will follow guidance in self-selecting foods on one day per week.
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Alpha-diversity of the gut microbiota
大体时间:Week 4
|
The diversity of microbial taxa in faecal samples at 4 weeks assessed by calculating alpha-diversity score from 16S ribosomal RNA sequencing.
|
Week 4
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Absolute and change in alpha-diversity of the gut microbiota
大体时间:Baseline, Week 4
|
Absolute and change in alpha-diversity as measured by the diversity of micriobial taxa in faecal samples via 16S RNA sequencing.
|
Baseline, Week 4
|
|
Beta-diversity of the gut microbiota
大体时间:Baseline, Week 4
|
The diversity of microbial taxa in faecal samples by calculating beta-diversity via 16S ribosomal RNA sequencing.
|
Baseline, Week 4
|
|
Microbiota composition
大体时间:Baseline, Week 4
|
Absolute and change in microbiota composition of faecal samples between baseline and Week 4 as assessed by 16S ribosomal RNA sequencing.
|
Baseline, Week 4
|
|
Targeted faecal and plasma metabolomics
大体时间:Baseline, Week 4
|
Absolute and change in short-chain fatty acids through Liquid Chromatography - Mass Spectrometry using validated assays.
|
Baseline, Week 4
|
|
Targeted faecal and plasma metabolomics
大体时间:Baseline, Week 4
|
Absolute and change in bile acids through Liquid Chromatography - Mass Spectrometry using validated assays.
|
Baseline, Week 4
|
|
Untargeted faecal metabolomics
大体时间:Baseline, Week 4
|
Metabolomics analysis via 1H NMR spectroscopy.
|
Baseline, Week 4
|
|
Faecal water content via oven drying
大体时间:Baseline, Week 4
|
Absolute and change in water content of faecal samples assessed via oven drying.
|
Baseline, Week 4
|
|
Stool frequency
大体时间:Baseline, Week 4
|
Absolute and change in stool frequency measured via prospective 7-day stool diary
|
Baseline, Week 4
|
|
Stool consistency
大体时间:Baseline, Week 4
|
Absolute and change in stool consistency measured by Bristol stool form scale. Scale from 1 to 7.
|
Baseline, Week 4
|
|
Gastrointestinal symptoms
大体时间:Baseline, Week 4
|
Absolute and change in gastrointestincal symptons measured by Gastrointestinal symptoms rating scale score.
Scored from 15 to 105 with lower scores indicating less severe symptoms.
|
Baseline, Week 4
|
|
Endothelial function
大体时间:Baseline, Week 4
|
Flow mediated dilation measured via ultrasound of arm.
|
Baseline, Week 4
|
|
Untargeted urine and plasma metabolomics
大体时间:Baseline, Week 4
|
Metabolomics measured via 1H NMR spectroscopy.
|
Baseline, Week 4
|
|
Targeted plasma and urine metabolomics
大体时间:Baseline, Week 4
|
Metabolomics via Liquid Chromatography-Mass Spectroscopy using validated assays.
|
Baseline, Week 4
|
|
Blood pressure
大体时间:Baseline, Week 4
|
Absolute and change in diastolic and systolic blood pressure.
|
Baseline, Week 4
|
|
Body composition
大体时间:Baseline, Week 4
|
Absolute and change in body composition measured via biolelectrical impedance analysis (BIA).
|
Baseline, Week 4
|
|
Waist circumference
大体时间:Baseline, Week 4
|
Absolute and change in waist circumference assessed by tape measure.
|
Baseline, Week 4
|
|
Dietary intake
大体时间:Baseline, Week 4
|
Dietary intake measured by aggregating EPIC Norfolk food frequency questionnaire, daily food and drink diaries and food checklists.
|
Baseline, Week 4
|
|
Biological markers of dietary intake
大体时间:Baseline, Week 4
|
Absolute and change in biomarkers of dietary intake as measured via validated assays.
|
Baseline, Week 4
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Health-related Quality of Life
大体时间:Baseline, Week 4
|
Absolute and change in SF-36 questionnaire scores.
|
Baseline, Week 4
|
|
Mental Health
大体时间:Baseline, Week 4
|
Absolute and change in Patient Health Questionnaire-8 and Anxiety and Depression Scale scores.
|
Baseline, Week 4
|
|
Diet acceptability
大体时间:Baseline, Week 4
|
Acceptability of diet measured through a diet acceptability questionnaire containing multiple choice and open-ended questions.
|
Baseline, Week 4
|
|
Diet satisfaction
大体时间:Week 4
|
Absolute diet satisfaction measured by Food benefits assessment scale.
Scored from 41 to 205 with a lower score indicating a higher diet satisfaction.
|
Week 4
|
|
Dietary adherence
大体时间:Baseline, Week 4
|
Adherence to the intervention as measured by consumption of study meals, snacks and drinks.
|
Baseline, Week 4
|
合作者和调查者
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- HR-25/26-49752
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.