Oral Carnitine Challenge Test Guides Personalized Nutrition for CV Patients

NCT03781011 | Completed

• 1 other identifier: 201712030RIND
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators plan to use the recently developed oral carnitine challenge test (OCCT) as a tool to exam individual's trimethylamine N-oxide (TMAO) production capacity from their gut microbiota. By using data collected by OCCT, the investigators defined subjects as high-TMAO producer or low-TMAO producer and apply low carnitine/choline diet as dietary intervention for the high-TMAO producers. After dietary intervention for two months, the investigators conducted OCCT for the participants and compare the TMAO production capacity before and after the dietary intervention.

Conditions

Dietary Modification; Cardiovascular Diseases

Keywords

Gut microbiota; Trimethylamine N-oxide; Oral carnitine challenge test; Cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• TMAO production capacity

  TMAO production capacity is measured by calculating the area under the curve of TMAO levels (quantification by LC-MS/MS) during the procedure of oral carnitine challenge test

  Baseline, at the second month (following a two-month vegetarian diet intervention), and at the fifth month (after resuming a regular diet for three months).

Secondary Outcomes (1)

• Compositional and functional changes of gut microbiota

  Baseline, at the second month (following a two-month vegetarian diet intervention), and at the fifth month (after resuming a regular diet for three months).

Study Arms (1)

Vegetarian diet intervention

EXPERIMENTAL

Patients identified as high-TMAO producers through the oral carnitine challenge test will be invited to participate in a two-month vegetarian diet intervention, supervised by a registered dietitian.

Behavioral: Vegetarian diet intervention

Interventions

Vegetarian diet intervention BEHAVIORAL

Patients will received dietary education and supervision by dietician to avoid high carnitine/choline foods including red meat, eggs...etc.

Vegetarian diet intervention

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with risks of cardiovascular disease (CAD) or CAD patients proved by coronary angiography

You may not qualify if:

• age \< 20, hx of GI surgery, hx of malignancy, antibiotic or probiotic or carnitine supplement use within one month, liver cirrhosis, end stage chronic renal disease

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Ming-shiang Wu

  National Taiwan University Hospital

  STUDY DIRECTOR

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

Model Details: Participants identified as high-TMAO producers through the oral carnitine challenge test will be invited to participate in a two-month vegetarian diet intervention.

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 19, 2018
• Study Start: October 19, 2018
• Primary Completion: October 19, 2019
• Study Completion: October 19, 2020
• Last Updated: December 18, 2023

Record last verified: 2020-10

Locations

TW (1)