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Investigating the Gut Microbiota Modulation Effects of Allicin for Cardiovascular Disease Protection and Establishing Microbiota Directed Personalized Nutrition Guidance With Novel Humanized Gnotobiotic Mice Model, Microbial Culturomics and Metabolomic Technique

Primary Purpose

Atherosclerosis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Raw garlic juice containing allicin
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Atherosclerosis

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Raw garlic juice

Arm Description

Raw garlic juice treatment group

Outcomes

Primary Outcome Measures

Plasma and urine TMAO level (ppm)
Quantitation of plasma and urine TMAO level by LC-MS
Compositional analysis of gut microbiota (% of different bacteria species)
Next-generation sequencing and bioinformatics

Secondary Outcome Measures

Full Information

First Posted
September 6, 2020
Last Updated
September 14, 2020
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04545879
Brief Title
Investigating the Gut Microbiota Modulation Effects of Allicin for Cardiovascular Disease Protection and Establishing Microbiota Directed Personalized Nutrition Guidance With Novel Humanized Gnotobiotic Mice Model, Microbial Culturomics and Metabolomic Technique
Official Title
Investigating the Gut Microbiota Modulation Effects of Allicin for Cardiovascular Disease Protection and Establishing Microbiota Directed Personalized Nutrition Guidance With Novel Humanized Gnotobiotic Mice Model, Microbial Culturomics and Metabolomic Technique
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
May 18, 2019 (Actual)
Study Completion Date
May 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Trimethylamine N-oxide (TMAO) was recently discovered as a novel and independent risk factor for promoting atherosclerosis while it is generated from dietary carnitine through the metabolism of gut microbiota for decades. Allicin, the major compound in raw garlic juice, is a naturally antimicrobial phytochemical found in raw garlic juice and easily acquired from the diet. Investigators' previous study suggests dietary allicin reduces the transformation of L-carnitine to TMAO through the impact on gut microbiota in mice. Therefore, it is worth investigating whether raw garlic juice intake could reduce the TMAO productivity of human gut microbiota as well as modulate gut microflora. Investigators plan to recruit 10 TMAO producers to receive garlic juice for one week. The plasma and urine TMAO concentration will be measured by the LC-MS, and the gut microbiota composition will be analyzed by the next-generation sequencing, through bioinformatics analysis. Investigators expected after intake garlic juice for one week, it could prevent the cardiovascular disease risk via gut microbiota modulation and reduction of plasma and urine TMAO. Screening of the TMAO producer: The healthy participants were recruited, the criteria as follows: (1) age ≥ 20 years old; (2) no exposure to antibiotics, probiotics, or carnitine supplements within the previous month; (3) have no history of chronic diseases including, diabetes mellitus, myasthenia gravis, chronic renal disease, hyperparathyroidism, epilepsy, and severe anemia; (4) Participants were excluded from the study if they reported recent gastrointestinal discomfort (such as abdominal pain or diarrhea). To screening the TMAO producer, Investigators use the oral carnitine challenge test (OCCT) method which previously exhibited better efficacy than fasting plasma TMAO to identify the TMAO producer phenotype. All of the participants fasted at least 8 hours before performing OCCT. 1500 mg of L-carnitine (3 tablets, General Nutrition Centers, Inc., USA) orally administrated to the participants. The blood and urine of participants were collected at 0, 24, 48, and 72 hours after carnitine intake. Participants with plasma TMAO ≧ 10 μM after OCCT were defined as high TMAO producers and proceeded into the garlic juice intervention test. Garlic Juice Intervention: High-TMAO producers asked to consume 55 mL of raw garlic juice (48 mg of allicin equivalent) once a day during dinner for one week. High-TMAO producers suggested consuming the garlic juice with a meal. The high-TMAO producers were free to choose their diet, no restriction on the type of food. After one week of raw garlic juice intervention, the second OCCT was performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Raw garlic juice
Arm Type
Experimental
Arm Description
Raw garlic juice treatment group
Intervention Type
Dietary Supplement
Intervention Name(s)
Raw garlic juice containing allicin
Intervention Description
Fresh garlic juice containing around 48mg allicin for 7 days
Primary Outcome Measure Information:
Title
Plasma and urine TMAO level (ppm)
Description
Quantitation of plasma and urine TMAO level by LC-MS
Time Frame
6 months
Title
Compositional analysis of gut microbiota (% of different bacteria species)
Description
Next-generation sequencing and bioinformatics
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 20-65 years old Healthy subjects with TMAO producing ability Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Shiang Wu
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Investigating the Gut Microbiota Modulation Effects of Allicin for Cardiovascular Disease Protection and Establishing Microbiota Directed Personalized Nutrition Guidance With Novel Humanized Gnotobiotic Mice Model, Microbial Culturomics and Metabolomic Technique

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