NCT04635306

13C-Spirulina Nitrogen Content GEBT Study

Determination of the Effect of 13C-Spirulina Nitrogen Content on In-vivo 13C-Spirulina Gastric Emptying Breath Test (GEBT) Results

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Cairn Diagnostics · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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 7.9% Nitrogen content. On a second occasion, a low nitrogen GEBT in which the test meal will contain 13C-Spirulina with a 6.4% 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.

Conditions

• Gastroparesis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Approved GEBT test meal	FDA-approve GEBT test meal

Timeline

• Start date: 2020-10-21
• Primary completion: 2021-06-25
• Completion: 2021-06-25
• First posted: 2020-11-19
• Last updated: 2021-08-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study