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

Nutrition, Healthy Clinical Trial

— SUSUGUT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05231317
• Other study ID #: REC/20/0008
• Status: Completed
• Phase: N/A
• Start date: July 2, 2021
• Est. completion date: December 17, 2021

Study information

• Verified date: January 2022
• Source: University of Ulster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 17, 2021
• Est. primary completion date: December 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Microbiota

Intervention

Other:
• Plant-based diet
16 days with all foods provided
• Western diet
16 days with all foods provided

Locations

Country	Name	City	State
United Kingdom	Human Intervention Studies Unit, Ulster University	Coleraine	Londonderry

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulster	Fondazione Edmund Mach

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut microbiota changes	Significant changes in the number of bifidobacteria	Change over 14 days
Primary	Quantification of Trimethylamine N-oxide	Changes in response to L-Carnitine challenge	Day 16
Secondary	Bioactivity of faecal water	Measured by using faecal water as basis for growth media (ex vivo measure)	Change over 14 days
Secondary	Effects on inflammatory markers of both diets	Cytokine analysis via ELISA test (MagPix)	Change over 14 days
Secondary	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
Secondary	Quantification of phytochemicals	Measured by LC-MS	Change over 14 days
Secondary	Quantification of Short Chain Fatty Acids (SCFA)	Measured by nuclear magnetic resonance (NMR)	Change over 14 days