NCT04545879

Brief Summary

Investigators recruited 10 trimethylamine N-oxide (TMAO) producers to test the effect of garlic juice containing allicin on gut microbiota modulation and TMAO production.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 18, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 11, 2020

Completed
Last Updated

September 16, 2020

Status Verified

February 1, 2019

Enrollment Period

2 months

First QC Date

September 6, 2020

Last Update Submit

September 14, 2020

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (2)

  • Plasma and urine TMAO level (ppm)

    Quantitation of plasma and urine TMAO level by LC-MS

    6 months

  • Compositional analysis of gut microbiota (% of different bacteria species)

    Next-generation sequencing and bioinformatics

    6 months

Study Arms (1)

Raw garlic juice

EXPERIMENTAL

Raw garlic juice treatment group

Dietary Supplement: Raw garlic juice containing allicin

Interventions

Raw garlic juice containing allicinDIETARY_SUPPLEMENT

Fresh garlic juice containing around 48mg allicin for 7 days

Raw garlic juice

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20-65 years old
  • Healthy subjects with TMAO producing ability

You may not qualify if:

  • Exposure to antibiotics, probiotics, or carnitine supplements within the previous month
  • Have a history of chronic diseases including, diabetes mellitus, myasthenia gravis, chronic renal disease, hyperparathyroidism, epilepsy, and severe anemia
  • Have gastrointestinal discomfort (such as abdominal pain or diarrhea)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ming-Shiang Wu

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2020

First Posted

September 11, 2020

Study Start

March 18, 2019

Primary Completion

May 18, 2019

Study Completion

May 18, 2019

Last Updated

September 16, 2020

Record last verified: 2019-02

Locations

TW(1)