Oral Carnitine Challenge Test Guides Personalized Nutrition for CV Patients

Cardiovascular Diseases Clinical Trial

Official title:

Investigation on Clinical Application of Oral Carnitine Challenge Test as a Guidance of Personalized Nutrition for Patients With Cardiovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03781011
• Other study ID #: 201712030RIND
• Status: Completed
• Phase: N/A
• Start date: October 19, 2018
• Est. completion date: October 19, 2020

Study information

• Verified date: October 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 19, 2020
• Est. primary completion date: October 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Dietary Modification

Intervention

Behavioral:
• Vegetarian diet intervention
Patients will received dietary education and supervision by dietician to avoid high carnitine/choline foods including red meat, eggs...etc.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compositional and functional changes of gut microbiota	The compositional and functional changes of gut microbiota will be evaluated by shotgun metagenome sequencing. Taxonomy will be calculated as relative abundance of species-level genome bins (SGBs) and specific bacteria genes will be quantified as Reads Per Kilobase per Million (RPKM).	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).