13C-Spirulina Nitrogen Content GEBT Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastroparesis

Intervention / Treatment
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* Diagnostic Test: Approved GEBT test meal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Nitrogen GEBT test meal<br>GEBT test meal containing low %N content (below 7%) | Diagnostic Test: Approved GEBT test meal<br>* FDA-approve GEBT test meal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroenterology, Gastric emptying breath test