Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04545879
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2020-09-06
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
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None