Human Intervention Studies Unit, Ulster University
Coleraine, Londonderry, BT52 1SA, United Kingdom
NCT Number: NCT05231317
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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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Coleraine, Londonderry, BT52 1SA, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
16 days with all foods provided
16 days with all foods provided
Time frame: Change over 14 days
Significant changes in the number of bifidobacteria
Time frame: Day 16
Changes in response to L-Carnitine challenge
Time frame: Change over 14 days
Measured by using faecal water as basis for growth media (ex vivo measure)
Time frame: Change over 14 days
Cytokine analysis via ELISA test (MagPix)
Time frame: Day 14
Co-culturing the aqueous phase of faeces with C. difficile to assess changes in its biology
Time frame: Change over 14 days
Measured by LC-MS
Time frame: Change over 14 days
Measured by nuclear magnetic resonance (NMR)
University of Ulster
Other
Acronym: SUSUGUT
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