Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04635306
Status:
TERMINATED
Last Update Posted:
2021-08-03
First Post:
2020-11-13
Brief Title:
13C-Spirulina Nitrogen Content GEBT Study
Sponsor:
Cairn Diagnostics
Organization:
Cairn Diagnostics
Study Overview
Official Title:
Determination of the Effect of 13C-Spirulina Nitrogen Content on In-vivo 13C-Spirulina Gastric Emptying Breath Test GEBT Results
Status:
TERMINATED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Initial results showed no equivalence between GEBT test meals with low nitrogen versus a standard GEBT test meal
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether there is a difference in the human in vivo response to 13C-Spirulina meals manufactured using 13C-Spirulina containing different levels of protein as measured by nitrogen
Detailed Description:
In this study participants will be administered the standard FDA-approved GEBT in which the test meals contain 13C-Spirulina that has 79 Nitrogen content On a second occasion a low nitrogen GEBT in which the test meal will contain 13C-Spirulina with a 64 Nitrogen content will be administered Both sets of GEBTs have been manufactured under full cGMPs and both will be administered to the participants according to the FDA-approved GEBT labeling The two in vivo results of the two independent GEBT test administrations in the study cohort will be compared to determine whether there is any significant different in in vivo 13CO2 signaling
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None