Trial record 5 of 62 for:    Open Studies | "Malabsorption Syndromes"

Method To Measure Protein Digestion & Absorption

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Texas A&M University
Sponsor:
Information provided by (Responsible Party):
Marielle PKJ Engelen, PhD, Texas A&M University
ClinicalTrials.gov Identifier:
NCT02065141
First received: November 26, 2013
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

The aim of the present study is to validate a new method in healthy volunteers that is able to measure protein digestion and absorption simultaneously. The ultimate goal for future research is to apply this method to quantify digestion and absorption in patients who are suspect of impaired digestion and absorption resulting in loss of nutrients, such as critically ill.

Depending upon the information provided by this study we can develop a new research protocol in patients who are suspect of maldigestion and/or malabsorption, such as critically ill, and subsequently develop treatment strategies to improve protein digestion and absorption in these patient groups.


Condition Intervention
Healthy
Malabsorption
Drug: Indomethacin to induce small changes in absorption

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Validation Of A New Method To Simultaneously Measure Protein Digestion And Absorption

Resource links provided by NLM:


Further study details as provided by Texas A&M University:

Primary Outcome Measures:
  • Protein digestion and absorption, reflected by the ratio's in plasma of a combination of orally and intravenously provided stable isotope amino acids (partly as the protein spirulina). [ Time Frame: In postabsorptive and prandial state every 20 minutes up to 8 hours before each sip feeding on study day ] [ Designated as safety issue: No ]
    Digestion of the protein spirulina and (change in) the absorption of the amino acid phenylalanine and allo-isoleucine.


Estimated Enrollment: 20
Study Start Date: August 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
protein digestion, protein absorption
Indomethacin to induce small changes in absorption
Drug: Indomethacin to induce small changes in absorption
Indomethacin 125 mg
Other Name: Indomethacin

Detailed Description:

The study involves 1 screening visit of approximately 1 hour and 1 test day of approximately 9 hours. On the study day protein digestion and absorption will be measured using a mixture of amino acids that are made slightly heavier than normal, called stable isotopes. Subjects will receive continuous feeding by sips and 125 mg of the NSAID Indomethacin. The Indomethacin is provided to induce small changes in absorption, which can be picked up by stable isotope technology.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male & female according to the investigator's or appointed staff's judgment
  • Age 50 years and older

Exclusion Criteria:

  • Abdominal complaints
  • History of gastro-intestinal (GI) diseases or GI surgery
  • Hypersensitivity to bromide, NSAIDs or food products (e.g. celiac disease)
  • Family history of inflammatory bowel disease
  • Alcoholism
  • Metabolic diseases including diabetes and hepatic or renal disorders
  • Presence of acute illness or metabolically unstable chronic illness
  • Failure to give informed consent
  • (Possible) pregnancy
  • Any other condition according to the PI or nurse that would interfere with the study or safety of the patient or influence the results
  • Use of non-steroidal anti-inflammatory drug (NSAID), antibiotic, antihistamine and/or proton pump inhibitor in the month prior to study day
  • Use of nutritional supplements within 5 days before test day
  • Presence of fever within the last 3 days prior to the study day
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02065141

Contacts
Contact: Marielle P Engelen, PhD 9792202282 mpkj.engelen@ctral.org
Contact: Gerdien C Ligthart-Melis, PhD 9794465627 gc.melis@ctral.org

Locations
United States, Texas
Texas A&M University Not yet recruiting
College Station, Texas, United States, 77843
Contact: Marielle P Engelen, Ph.D.    979-220-2282    mpkj.engelen@ctral.org   
Contact: Gerdien C Ligthart-Melis, Ph.D.    9794465627    gc.melis@ctral.org   
Principal Investigator: Marielle Engelen, Ph.D.         
Principal Investigator: Nicolaas E Deutz, Ph.D.         
Sub-Investigator: Gerdien C Ligthart-Melis, Ph.D.         
Sponsors and Collaborators
Texas A&M University
Investigators
Principal Investigator: Nicolaas E Deutz, PhD Texas A&M University
Principal Investigator: Marielle P Engelen, PhD Texas A&M University
Study Director: Gerdien C Ligthart-Melis, PhD Texas A&M University
  More Information

No publications provided

Responsible Party: Marielle PKJ Engelen, PhD, PhD, Texas A&M University
ClinicalTrials.gov Identifier: NCT02065141     History of Changes
Other Study ID Numbers: 2013-0758F
Study First Received: November 26, 2013
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Texas A&M University:
digestion
absorption
protein
amino acids

Additional relevant MeSH terms:
Malabsorption Syndromes
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Metabolic Diseases
Indomethacin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on October 23, 2014