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| Name | Class |
|---|---|
| Biotechnology and Biological Sciences Research Council | OTHER |
| University of Southampton | OTHER |
| University of Leeds | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Diet A | Active Comparator | Meals, snacks and drinks that contain plant foods provided by the research team for four weeks (6 days a week). |
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| Study Diet B | Active Comparator | Meals, snacks and drinks that contain plant foods provided by the research team for four weeks (6 days a week). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A diet containing plant foods | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Alpha-diversity of the gut microbiota | The diversity of microbial taxa in faecal samples at 4 weeks assessed by calculating alpha-diversity score from 16S ribosomal RNA sequencing. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute and change in alpha-diversity of the gut microbiota | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related Quality of Life | Absolute and change in SF-36 questionnaire scores. | Baseline, Week 4 |
| Mental Health | Absolute and change in Patient Health Questionnaire-8 and Anxiety and Depression Scale scores. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College London | Recruiting | London | SE1 9NH | United Kingdom |
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| Label | URL |
|---|---|
| Related Info | View source |
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| A diet containing different plant foods | Other | 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. |
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The diversity of microbial taxa in faecal samples by calculating beta-diversity via 16S ribosomal RNA sequencing.
| Baseline, Week 4 |
| Microbiota composition | 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 | Absolute and change in short-chain fatty acids through Liquid Chromatography - Mass Spectrometry using validated assays. | Baseline, Week 4 |
| Targeted faecal and plasma metabolomics | Absolute and change in bile acids through Liquid Chromatography - Mass Spectrometry using validated assays. | Baseline, Week 4 |
| Untargeted faecal metabolomics | Metabolomics analysis via 1H NMR spectroscopy. | Baseline, Week 4 |
| Faecal water content via oven drying | Absolute and change in water content of faecal samples assessed via oven drying. | Baseline, Week 4 |
| Stool frequency | Absolute and change in stool frequency measured via prospective 7-day stool diary | Baseline, Week 4 |
| Stool consistency | Absolute and change in stool consistency measured by Bristol stool form scale. Scale from 1 to 7. | Baseline, Week 4 |
| Gastrointestinal symptoms | 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 | Flow mediated dilation measured via ultrasound of arm. | Baseline, Week 4 |
| Untargeted urine and plasma metabolomics | Metabolomics measured via 1H NMR spectroscopy. | Baseline, Week 4 |
| Targeted plasma and urine metabolomics | Metabolomics via Liquid Chromatography-Mass Spectroscopy using validated assays. | Baseline, Week 4 |
| Blood pressure | Absolute and change in diastolic and systolic blood pressure. | Baseline, Week 4 |
| Body composition | Absolute and change in body composition measured via biolelectrical impedance analysis (BIA). | Baseline, Week 4 |
| Waist circumference | Absolute and change in waist circumference assessed by tape measure. | Baseline, Week 4 |
| Dietary intake | 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 | Absolute and change in biomarkers of dietary intake as measured via validated assays. | Baseline, Week 4 |
| Baseline, Week 4 |
| Diet acceptability | Acceptability of diet measured through a diet acceptability questionnaire containing multiple choice and open-ended questions. | Baseline, Week 4 |
| Diet satisfaction | 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 | Adherence to the intervention as measured by consumption of study meals, snacks and drinks. | Baseline, Week 4 |