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Oral Carnitine Challenge Test Guides Personalized Nutrition for CV Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03781011
Enrollment
50
Registered
2018-12-19
Start date
2018-10-19
Completion date
2020-10-19
Last updated
2023-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Dietary Modification

Keywords

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

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.

Detailed 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.

Interventions

BEHAVIORALVegetarian diet intervention

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

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
TMAO production capacityBaseline, at the second month (following a two-month vegetarian diet intervention), and at the fifth month (after resuming a regular diet for three months).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

Secondary

MeasureTime frameDescription
Compositional and functional changes of gut microbiotaBaseline, at the second month (following a two-month vegetarian diet intervention), and at the fifth month (after resuming a regular diet for three months).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).

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026