NCT05231317

Effect of the Sustainable Diet on Gut Microbiota and the Metabolome: a Randomised Crossover Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Ulster · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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).

Conditions

• Microbiota
• Nutrition, Healthy

Interventions

Type	Name	Description
OTHER	Plant-based diet	16 days with all foods provided
OTHER	Western diet	16 days with all foods provided

Timeline

• Start date: 2021-07-02
• Primary completion: 2021-12-17
• Completion: 2021-12-17
• First posted: 2022-02-09
• Last updated: 2022-02-09

Locations

1 site across 1 country: United Kingdom