Development Of An Innovative Panel of Methods To Measure Intestinal Macronutrient Digestion, Absorption, and Function

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01494909
• Date of registration: 15/12/2011
• Prospective Registration: No
• Primary sponsor: Texas A&M University
• Public title: Development Of An Innovative Panel of Methods To Measure Intestinal Macronutrient Digestion, Absorption, and Function
• Scientific title: Development Of An Innovative Panel of Methods To Measure Intestinal Macronutrient Digestion, Absorption, and Function
• Date of first enrolment: January 2011
• Target sample size: 31
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT01494909
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Nicolaas EP Deutz, MD, PhD
• Affiliation: University of Arkansas

Key inclusion & exclusion criteria

Inclusion Criteria:

Adult subjects with CF

1. Diagnosis of CF based on universal diagnostic criteria

2. Pancreatic insufficiency based on clinical diagnosis

3. Abnormal lipid digestion requiring pancreatic enzyme replacement therapy

4. Age is 18 years and older.

5. Admitted to UAMS for treatment of exacerbations of CF (inpatients) or under routine
medical control at the CF center of UAMS

6. Clinically stable CF at the time of enrollment

Healthy adults

1. Age is 18 years and older at the time of enrollment.

2. BMI between 18 and 35 kg/m2

Exclusion Criteria:

Pediatric and adult CF groups

1. Unstable metabolic diseases including liver (cirrhosis) or renal disease

2. Chronic respiratory failure with cor pulmonale

3. Any other condition according to the principle investigator or study physician would
interfere with proper conduct of study / safety of the patient

4. Failure to give assent / informed consent

5. Diagnosis of severe lung disease, defined as FEV1 < 35% predicted

Healthy adults

- Presence of acute or chronic unstable diseases such as liver, renal, heart or lung
disease

- Previous surgery less than 4 weeks prior to the experiment

- Recent involuntary weight loss (>10% in the past 3 months)

- Any documented autoimmune disease

- Any other condition according to the principle investigator or study physician would
interfere with collecting study samples

- Failure to give informed consent



Age minimum: 10 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Dietary Supplement: Ensure plus

Primary Outcome(s)

Fatty acid absorption during feeding and effect pancreatic enzyme intake [Time Frame: 8 hours]

Secondary Outcome(s)

Glucose absorption during feeding and effect pancreatic enzyme intake [Time Frame: 8 hours]

Protein digestion during feeding and effect pancreatic enzyme intake [Time Frame: 8 hours]

Secondary ID(s)

113047

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Arkansas Children's Hospital Research Institute

University of Arkansas