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| Name | Class |
|---|---|
| Fondazione Edmund Mach | OTHER |
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Unhealthy diets are closely linked to non-communicable diseases and constitute higher risk of morbidity and mortality than unsafe sex, alcohol, tobacco and drugs use combined. According to the World Health Organization (WHO), a healthy diet follows a plant-based pattern with low quantities of red meat and a low simple sugar intake. It would also reduce anthropological ecologic impact. We hypothesize that a plant-based diet will beneficially modify the gut microbiota and metabolome, influencing also Trimethylamine N-oxide (TMAO), a metabolite associated to CVD.
This study has a randomized single blind crossover design that compares a plant-based diet towards a control western diet. It is applied to volunteers aged 18-70 years, N=20. Each dietary intervention (plant-based and western) would last for 16 consecutive days separated by a minimum of 7 weeks washout period (intervention 1-washout-intervention 2). Samples of blood urine and faeces will be collected at day 1 and 14 of each intervention. On day 14 will be performed L-carnitine challenge with 1200mg of L-carnitine to test the levels of TMAO), in for the next 2 consecutive days (24h and 48h post treatment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Plant-based diet | Experimental | Diet rich in fruit and vegetables (42% carbohydrates, 17.2% fibres; 15% proteins and 43% fats). |
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| Active Comparator: Western diet | Active Comparator | Diet Rich in Processed Foods (48% carbohydrates, 10.4% fibres; 14% proteins and 39% fats). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant-based diet | Other | 16 days with all foods provided |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiota changes | Significant changes in the number of bifidobacteria | Change over 14 days |
| Quantification of Trimethylamine N-oxide | Changes in response to L-Carnitine challenge | Day 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Bioactivity of faecal water | Measured by using faecal water as basis for growth media (ex vivo measure) | Change over 14 days |
| Effects on inflammatory markers of both diets | Cytokine analysis via ELISA test (MagPix) |
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Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Intervention Studies Unit, Ulster University | Coleraine | Londonderry | BT52 1SA | United Kingdom |
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| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D066273 | Diet, Western |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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Cross-over single-blinded
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Single-blind
| Western diet |
| Other |
16 days with all foods provided |
|
| Change over 14 days |
| Ex vivo effects of faecal water on gut pathobionts | Co-culturing the aqueous phase of faeces with C. difficile to assess changes in its biology | Day 14 |
| Quantification of phytochemicals | Measured by LC-MS | Change over 14 days |
| Quantification of Short Chain Fatty Acids (SCFA) | Measured by nuclear magnetic resonance (NMR) | Change over 14 days |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |