Microbiota, Nutrition, Healthy
Conditions
Keywords
Plant-based diet, Western diet, Gut microbiota,, Trimethylamine N-oxide, Human intervention study.
Brief summary
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).
Interventions
OTHERPlant-based diet
16 days with all foods provided
OTHERWestern diet
16 days with all foods provided
Sponsors
Fondazione Edmund Mach
University of Ulster
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Single-blind
Intervention model description
Cross-over single-blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Free-living, apparently healthy adults * Bmi\>18 * Aged 18-70 years at recruitment * Non-smokers
Exclusion criteria
* Non-free-living adults * Adults \<18 or \>70 years at recruitment * BMI\<18 * Current smokers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiota changes | Change over 14 days | Significant changes in the number of bifidobacteria |
| Quantification of Trimethylamine N-oxide | Day 16 | Changes in response to L-Carnitine challenge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ex vivo effects of faecal water on gut pathobionts | Day 14 | Co-culturing the aqueous phase of faeces with C. difficile to assess changes in its biology |
| Bioactivity of faecal water | Change over 14 days | Measured by using faecal water as basis for growth media (ex vivo measure) |
| Quantification of Short Chain Fatty Acids (SCFA) | Change over 14 days | Measured by nuclear magnetic resonance (NMR) |
| Quantification of phytochemicals | Change over 14 days | Measured by LC-MS |
| Effects on inflammatory markers of both diets | Change over 14 days | Cytokine analysis via ELISA test (MagPix) |
Countries
United Kingdom
Outcome results
None listed