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

Ulster University

Status: Completed

Conditions: Nutrition, Healthy; Microbiota

Treatments: Other: Western diet; Other: Plant-based diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05231317

REC/20/0008

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Experimental: Plant-based diet

Experimental group

Description:

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

Treatment:

Other: Plant-based diet

Active Comparator: Western diet

Active Comparator group

Description:

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

Treatment:

Other: Western diet