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

• Sponsor: University of Ulster (Other)
• Overall Status: Completed
• CT.gov ID: NCT05231317
• Collaborator: Fondazione Edmund Mach (Other)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.5
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Microbiota; Nutrition, Healthy	Other: Plant-based diet; Other: Western diet	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Cross-over single-blindedCross-over single-blinded
• Masking: Single (Participant)
• Masking Description: Single-blind
• Primary Purpose: Prevention
• Official Title: Effect of the Sustainable Diet on Gut Microbiota and the Metabolome: a Randomised Crossover Study
• Actual Study Start Date: Jul 2, 2021
• Actual Primary Completion Date: Dec 17, 2021
• Actual Study Completion Date: Dec 17, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: Plant-based diet Diet rich in fruit and vegetables (42% carbohydrates, 17.2% fibres; 15% proteins and 43% fats).	Other: Plant-based diet; 16 days with all foods provided
Active Comparator: Active Comparator: Western diet Diet Rich in Processed Foods (48% carbohydrates, 10.4% fibres; 14% proteins and 39% fats).	Other: Western diet; 16 days with all foods provided

Outcome Measures

Primary Outcome Measures

1. Gut microbiota changes [Change over 14 days]

   Significant changes in the number of bifidobacteria

2. Quantification of Trimethylamine N-oxide [Day 16]

   Changes in response to L-Carnitine challenge

Secondary Outcome Measures

1. Bioactivity of faecal water [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 [Change over 14 days]

   Cytokine analysis via ELISA test (MagPix)

3. 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

4. Quantification of phytochemicals [Change over 14 days]

   Measured by LC-MS

5. Quantification of Short Chain Fatty Acids (SCFA) [Change over 14 days]

   Measured by nuclear magnetic resonance (NMR)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Human Intervention Studies Unit, Ulster University	Coleraine	Londonderry	United Kingdom	BT52 1SA

Sponsors and Collaborators

• University of Ulster
• Fondazione Edmund Mach

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Ulster
• ClinicalTrials.gov Identifier: NCT05231317
• Other Study ID Numbers: REC/20/0008
• First Posted: Feb 9, 2022
• Last Update Posted: Feb 9, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Ulster: Plant-based diet; Western diet; Gut microbiota,; Trimethylamine N-oxide; Human intervention study.

Study Results

No Results Posted as of Feb 9, 2022