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

NCT ID: NCT05231317

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-02
• Study Completion Date: 2021-12-17

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).

Conditions

Microbiota; Nutrition, Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Experimental: Plant-based diet

Diet rich in fruit and vegetables (42% carbohydrates, 17.2% fibres; 15% proteins and 43% fats).

Group Type: EXPERIMENTAL

Plant-based diet

Intervention Type: OTHER

16 days with all foods provided

Active Comparator: Western diet

Diet Rich in Processed Foods (48% carbohydrates, 10.4% fibres; 14% proteins and 39% fats).

Group Type: ACTIVE_COMPARATOR

Western diet

Intervention Type: OTHER

16 days with all foods provided

Interventions

Plant-based diet

16 days with all foods provided

Intervention Type: OTHER

Western diet

16 days with all foods provided

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondazione Edmund Mach

OTHER

Sponsor Role: collaborator

University of Ulster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Human Intervention Studies Unit, Ulster University

Coleraine, Londonderry, United Kingdom

Countries

United Kingdom

Other Identifiers

REC/20/0008

Identifier Type: -

Identifier Source: org_study_id