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The aim of this study is to evaluate the impact of a diversified plant-based meal on the gut microbiome and its composition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oat based porridge | Placebo Comparator | Oat based porridge prepared with 64g of oat, 200ml of milk and 10 g of honey by the participant and consumed orally daily for 14 days as breakfast replacement |
|
| Enriched plant-based meal | Active Comparator | Enriched plant-based meal pots (400 g) mixed with 25g of seeds and nuts consumed orally daily for 14 days as breakfast replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oat based porridge | Dietary Supplement | Consume one preparation per day, orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiota diversity & composition | Measured by Next Generation Sequencing (NGS) | Throughout 14 days of product intake |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life using SF-36 questionnaire (Short Form 36 Health Survey) | SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. Score ranging from 0 to 100 (higher scores indicate better health status). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Innovation Lab | Lausanne | Canton of Vaud | 1004 | Switzerland |
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| plant based preparation |
| Dietary Supplement |
Consume one preparation per day, orally |
|
| Throughout 14 days of product intake |
| Change in Short Chain Fatty Acids (SCFA) in the stool | Measured using Gas Chromatography (GC) | Throughout 14 days of product intake |
| Gastrointestinal Symptom Rating Scale (GSRS) | Validated questionnaire exploring the presence and severity of GI symptoms over the previous 7 days. The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting reflux, abdominal pain, indigestion, diarrhea and constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. The effect of the interventions on the GSRS will be assessed by a linear mixed model and will take into account information on this from all 7 days of treatment. | Throughout 14 days of product intake |