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Oral Carnitine Challenge Test Guides Personalized Nutrition for CV Patients

NCT ID: NCT03781011

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-19

Study Completion Date

2020-10-19

Brief Summary

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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.

Detailed Description

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Patients diagnosed with cardiovascular disease at the CV clinics are being recruited to undergo the Oral Carnitine Challenge Test (OCCT) to assess the TMAO production capacity of their gut microbiota. Participants identified as high-TMAO producers will be invited to partake in a two-month vegetarian diet intervention, supervised by a registered dietitian, followed by a three-month period of reverting to their regular diet. The OCCT will be conducted before and after the vegetarian diet intervention, as well as after the diet recovery phase. Fecal samples will be collected and analyzed at the baseline, in the second month, and in the fifth month of the study.

Conditions

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Dietary Modification Cardiovascular Diseases

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Vegetarian diet intervention

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.

Group Type EXPERIMENTAL

Vegetarian diet intervention

Intervention Type BEHAVIORAL

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

Interventions

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Vegetarian diet intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ming-shiang Wu

Role: STUDY_DIRECTOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201712030RIND

Identifier Type: -

Identifier Source: org_study_id