Skip to main content
OpenTrials
Completed

NCT Number: NCT05231317

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Intervention Studies Unit, Ulster University

Coleraine, Londonderry, BT52 1SA, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plant-Based Diet

Other

16 days with all foods provided

Western Diet

Other

16 days with all foods provided

Primary outcomes

  1. Gut microbiota changes

    Time frame: Change over 14 days

    Significant changes in the number of bifidobacteria

  2. Quantification of Trimethylamine N-oxide

    Time frame: Day 16

    Changes in response to L-Carnitine challenge

Secondary outcomes

  1. Bioactivity of faecal water

    Time frame: Change over 14 days

    Measured by using faecal water as basis for growth media (ex vivo measure)

  2. Effects on inflammatory markers of both diets

    Time frame: Change over 14 days

    Cytokine analysis via ELISA test (MagPix)

  3. Ex vivo effects of faecal water on gut pathobionts

    Time frame: Day 14

    Co-culturing the aqueous phase of faeces with C. difficile to assess changes in its biology

  4. Quantification of phytochemicals

    Time frame: Change over 14 days

    Measured by LC-MS

  5. Quantification of Short Chain Fatty Acids (SCFA)

    Time frame: Change over 14 days

    Measured by nuclear magnetic resonance (NMR)

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Collaborators

  • Fondazione Edmund Mach

Registry information

Acronym: SUSUGUT

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 9, 2022
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.