NCT05231317

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 28, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
Last Updated

February 9, 2022

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

January 28, 2022

Last Update Submit

January 28, 2022

Conditions

MicrobiotaNutrition, Healthy

Keywords

Plant-based dietWestern dietGut microbiota,Trimethylamine N-oxideHuman intervention study.

Outcome Measures

Primary Outcomes (2)

  • Gut microbiota changes

    Significant changes in the number of bifidobacteria

    Change over 14 days

  • Quantification of Trimethylamine N-oxide

    Changes in response to L-Carnitine challenge

    Day 16

Secondary Outcomes (5)

  • Bioactivity of faecal water

    Change over 14 days

  • Effects on inflammatory markers of both diets

    Change over 14 days

  • Ex vivo effects of faecal water on gut pathobionts

    Day 14

  • Quantification of phytochemicals

    Change over 14 days

  • Quantification of Short Chain Fatty Acids (SCFA)

    Change over 14 days

Study Arms (2)

Experimental: Plant-based diet

EXPERIMENTAL

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

Other: Plant-based diet

Active Comparator: Western diet

ACTIVE COMPARATOR

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

Other: Western diet

Interventions

Plant-based dietOTHER

16 days with all foods provided

Experimental: Plant-based diet
Western dietOTHER

16 days with all foods provided

Active Comparator: Western diet

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Free-living, apparently healthy adults
  • Bmi\>18
  • Aged 18-70 years at recruitment
  • Non-smokers

You may not qualify if:

  • Non-free-living adults
  • Adults \<18 or \>70 years at recruitment
  • BMI\<18
  • Current smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Intervention Studies Unit, Ulster University

Coleraine, Londonderry, BT52 1SA, United Kingdom

Location

MeSH Terms

Interventions

Diet, Plant-BasedDiet, Western

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single-blind
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Cross-over single-blinded
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2022

First Posted

February 9, 2022

Study Start

July 2, 2021

Primary Completion

December 17, 2021

Study Completion

December 17, 2021

Last Updated

February 9, 2022

Record last verified: 2022-01

Locations

GB(1)