13C-Spirulina Nitrogen Content GEBT Study

July 28, 2021 updated by: Cairn Diagnostics

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Brentwood, Tennessee, United States, 37027
        • Cairn Diagnostics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in vivo 13C-Spirulina GEBT response
Time Frame: Up to 2 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairn Diagnostics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2020

Primary Completion (Actual)

June 25, 2021

Study Completion (Actual)

June 25, 2021

Study Registration Dates

First Submitted

November 13, 2020

First Submitted That Met QC Criteria

November 13, 2020

First Posted (Actual)

November 19, 2020

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-CD-041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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