Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518343
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Trimethylamine N-oxide Effects of a Pomegranate Supplement Simultaneously With Carnitine TESSA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Trimethylamine N-oxide TMAO-Reducing Effects of a Pomegranate Supplement Simultaneously Administered With L-carnitine
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TESSA
Brief Summary:
Trimethylamine N-oxide TMAO is produced in some individuals whose diets include meat fish and dairyThese foods are rich in L-carnitine L-carnitine is metabolised by the liver and gut microorganisms bacteria into TMAO In the TESSA study investigators will explore whether pomegranate extract can lower the production of TMAO in healthy men and women This reduction in TMAO production has been associated with decreasing a persons risk of heart disease
Detailed Description:
The TESSA study is a 18 day randomised double-blind placebo-controlled two-arm crossover pilot study conducted at the NIHR National Institute for Health and Care Research Norfolk Clinical Research Facility CRF in the Quadram Institute in Norwich Investigators are seeking men and women over the age of 18 years who habitually consume meat fish andor eggs and are TMAO producers to determine whether pomegranate extract affects L-carnitine metabolism compared to a matched placebo This study is conducted in two phases The first phase involves two study visits where investigators will identify and invite TMAO producing individuals to continue to the second phase of this study Moreover investigators will ask the participant to complete a food frequency questionnaire The second phase involves two intervention periods which are separated by a 10 day washout Each intervention period begins with a run-in followed by three study visits Investigators will precisely quantify the absorption blood plasma concentrations over time pharmacokinetic study and metabolism of L-carnitine and its products of metabolism which includes TMAO Additionally investigators will examine pomegranate metabolism and excretion with timed urine collections and stool samples
Participants will consume three L-carnitine capsules at the first visit during the first phase In the second phase participants will consume L-carnitine capsules with the intervention capsules pomegranate extract or placebo for the first intervention period then after the washout period participants will crossover and consume L-carnitine capsules with the other intervention capsules for the second intervention period For each intervention period three L-carnitine capsules with four intervention capsules at the first visit following the run-in During the second phase starting at the run-in period participants will be asked to follow a standardized controlled diet which will be low in choline L-carnitine and ellagitannins
Participants will consume three L-carnitine capsules at the first visit during the first phase In the second phase participants will consume L-carnitine capsules with the intervention capsules pomegranate extract or placebo for the first intervention period then after the washout period participants will crossover and consume L-carnitine capsules with the other intervention capsules for the second intervention period For each intervention period three L-carnitine capsules with four intervention capsules at the first visit following the run-in During the second phase starting at the run-in period participants will be asked to follow a standardized controlled diet which will be low in choline L-carnitine and ellagitannins
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None