13C-Spirulina Nitrogen Content GEBT Study

Cairn Diagnostics12 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Gastroparesis

Interventions

Approved GEBT test mealDIAGNOSTIC_TEST

FDA-approve GEBT test meal

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Males and females, 18-85 years old at time of signing consent form * Ability to eat test meal and provide breath samples Exclusion Criteria: * History or physical exam suggestive of systemic disease such as diabetes mellitus or pathophysiologic disorders such as renal failure, chronic heart disease, chronic respiratory disease, liver disease or malabsorption syndrome * Symptoms consistent with delayed gastric emptying * History of abdominal surgery except appendectomy * Use of any medications that may alter gastric motility within two days of the study * Use of narcotics or anticholinergics within two days of the study * Females on hormone replacement therapy other than birth control medications * Receipt of an investigational drug within 4 weeks of the study * Pregnancy * Intolerance or allergy to any component of Gastric Emptying Breath Test meal * History of neurologic or psychiatric disorder

Locations (1)

Cairn Diagnostics

Brentwood, Tennessee, United States

Outcomes

Primary Outcomes

Difference in vivo 13C-Spirulina GEBT response

Determining the difference between measure gastric emptying rate (kPCD) results produced from the low %N 13C-Spirulina GEBT test meal and the FDA-approved test meal

Time frame: Up to 2 weeks

Data from ClinicalTrials.gov

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