Cystic FibrosisNCT01494909
Development Of An Innovative Panel of Methods To Measure Intestinal Macronutrient Digestion, Absorption, and Function
A study testing Ensure plus in people with Cystic Fibrosis, run by Texas A&M University at 1 site in United States.
Trial summary
Malnutrition is a significant problem in children and adults with Cystic fibrosis (CF). An impaired intestinal digestion and absorption capacity is one of the main factors responsible for the malnutrition in CF. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Ensure plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2010to 7 Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult subjects with CF
- Diagnosis of CF based on universal diagnostic criteria
- Pancreatic insufficiency based on clinical diagnosis
- Abnormal lipid digestion requiring pancreatic enzyme replacement therapy
- Age is 18 years and older.
- Admitted to UAMS for treatment of exacerbations of CF (inpatients) or under routine medical control at the CF center of UAMS
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- Clinically stable CF at the time of enrollment
- Healthy adults
- Age is 18 years and older at the time of enrollment.
- BMI between 18 and 35 kg/m2
Who cannot join
- Pediatric and adult CF groups
- Unstable metabolic diseases including liver (cirrhosis) or renal disease
- Chronic respiratory failure with cor pulmonale
- Any other condition according to the principle investigator or study physician would interfere with proper conduct of study / safety of the patient
- Failure to give assent / informed consent
- Diagnosis of severe lung disease, defined as FEV1 < 35% predicted
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Malnutrition is a significant problem in children and adults with Cystic fibrosis (CF). An impaired intestinal digestion and absorption capacity is one of the main factors responsible for the malnutrition in CF. This impairment starts early in life, leading to malnutrition, muscle weakness, impaired immune and lung function associated with poor prognosis. As low BMI and body weight is strongly associated with morbidity and mortality, a reduction in weight loss in CF and its manifestations would save the healthcare system substantially per year. Simple methods to measure the digested portions and utilization of nutrients and the effectiveness of pancreatic enzyme preparations and medications in CF are not available. Developing a panel of methods to accurately measure gut digestion, absorption and function will lead to studies optimizing nutritional regimen and pancreatic enzyme replacement therapy in CF. Furthermore, it will provide detailed insight in the disease and age related mechanisms of gut dysfunction in CF. Finally, it will provide required information that will lead to implement new strategies to improve gut health in order to enhance nutritional status, quality of life and survival.
The hypothesis is that intestinal macronutrient digestion, absorption and function in CF can be quantified by an innovative panel of methods using stable isotopes. With this panel of methods, information can be obtained on the effect of disease progression on lipid, protein and glucose digestion and absorption and on gut function in CF as well as in other diseases and conditions characterized by a compromised gut. Furthermore, the optimal nutritional regimen and pancreatic enzyme therapy if applicable can be evaluated in these diseases. In the present study the investigators will study: 1. Pediatric patients with CF at Arkansas Children's Hospital; 2. Adult patients with CF at University of Arkansas for Medical Sciences. 3. Healthy control subjects. Diagnosis of CF is made based on universal diagnostic criteria. All CF patients are characterized by abnormal lipid digestion based on clinical and or laboratory (72 hour fat analysis or fecal elastase measurement) diagnosis, and requiring pancreatic enzyme replacement therapy, and no presence of unstable metabolic diseases. Additional criteria for the CF pediatric inpatients are: admitted to ACH for treatment of exacerbations of CF disease, clinically stable. The CF outpatients are stable outpatients with pancreatic insufficiency.
- Conditions
- Cystic Fibrosis
- Being tested
- Ensure plus
- Keywords
- protein digestion, fat absorption, gut function, glucose absorption, CF, pancreatic intake, feeding
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ensure plusDietary supplement
Ensure plus sip feeds every 20 min during 6 hours. After 2 hour pancreatic enzyme intake in CF
| Study group | Role | What they receive |
|---|---|---|
| Ensure plus | Experimental | Ensure sip feeds during 6 hours. After 2 hours pancreatic intake Receives: Dietary Supplement: Ensure plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatty acid absorption during feeding and effect pancreatic enzyme intake
Enrichment in palmitic acid and tripalmitin fatty acids in plasma
Measured: 8 hours
Secondary outcomes (2)
Protein digestion during feeding and effect pancreatic enzyme intake
Ratio enrichment in plasma free phenylalanine vs from protein spirulina
Measured: 8 hours
Glucose absorption during feeding and effect pancreatic enzyme intake
Plasma and urine 3-O-methyl-D-glucose
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study start15 Nov 2010
- Primary completion7 Dec 2011
- Study completion7 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- Arkansas Children's Hospital Research Institute, University of Arkansas
- Responsible party
- Principal investigator, Marielle PKJ Engelen, PhD, Texas A&M University
- Investigators
- Nicolaas EP Deutz, MD, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494909
- Sponsor's protocol ID
- 113047
- Status last verified
- Sep 2025
- First submitted
- 15 Dec 2011
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Engelen MP, Com G, Anderson PJ, Deutz NE. New stable isotope method to measure protein digestibility and response to pancreatic enzyme intake in cystic fibrosis. Clin Nutr. 2014 Dec;33(6):1024-32. doi: 10.1016/j.clnu.2013.11.004. Epub 2013 Nov 9.
PubMed 24268783
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development Of An Innovative Panel of Methods To Measure Intestinal Macronutrient Digestion, Absorption, and Function
- ClinicalTrials.gov ID
- NCT01494909
- Acronym / sponsor ID
- 113047
- Conditions
- Cystic Fibrosis
- Keywords
- protein digestion, fat absorption, gut function, glucose absorption, CF, pancreatic intake, feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- Arkansas Children's Hospital Research Institute, University of Arkansas
- Study start
- 15 Nov 2010 (actual)
- Primary completion
- 7 Dec 2011 (actual)
- Study completion
- 7 Dec 2011 (actual)
- First posted
- 19 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Malnutrition is a significant problem in children and adults with Cystic fibrosis (CF). An impaired intestinal digestion and absorption capacity is one of the main factors responsible for the malnutrition in CF. This impairment starts early in life, leading to malnutrition, muscle weakness, impaired immune and lung function associated with poor prognosis. As low BMI and body weight is strongly associated with morbidity and mortality, a reduction in weight loss in CF and its manifestations would save the healthcare system substantially per year. Simple methods to measure the digested portions and utilization of nutrients and the effectiveness of pancreatic enzyme preparations and medications in CF are not available. Developing a panel of methods to accurately measure gut digestion, absorption and function will lead to studies optimizing nutritional regimen and pancreatic enzyme replacement therapy in CF. Furthermore, it will provide detailed insight in the disease and age related mechanisms of gut dysfunction in CF. Finally, it will provide required information that will lead to implement new strategies to improve gut health in order to enhance nutritional status, quality of life and survival.
The hypothesis is that intestinal macronutrient digestion, absorption and function in CF can be quantified by an innovative panel of methods using stable isotopes. With this panel of methods, information can be obtained on the effect of disease progression on lipid, protein and glucose digestion and absorption and on gut function in CF as well as in other diseases and conditions characterized by a compromised gut. Furthermore, the optimal nutritional regimen and pancreatic enzyme therapy if applicable can be evaluated in these diseases. In the present study the investigators will study: 1. Pediatric patients with CF at Arkansas Children's Hospital; 2. Adult patients with CF at University of Arkansas for Medical Sciences. 3. Healthy control subjects. Diagnosis of CF is made based on universal diagnostic criteria. All CF patients are characterized by abnormal lipid digestion based on clinical and or laboratory (72 hour fat analysis or fecal elastase measurement) diagnosis, and requiring pancreatic enzyme replacement therapy, and no presence of unstable metabolic diseases. Additional criteria for the CF pediatric inpatients are: admitted to ACH for treatment of exacerbations of CF disease, clinically stable. The CF outpatients are stable outpatients with pancreatic insufficiency.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ensure plus | Experimental | Dietary Supplement: Ensure plusEnsure sip feeds during 6 hours. After 2 hours pancreatic intake |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Adult subjects with CF
- Diagnosis of CF based on universal diagnostic criteria
- Pancreatic insufficiency based on clinical diagnosis
- Abnormal lipid digestion requiring pancreatic enzyme replacement therapy
- Age is 18 years and older.
Key exclusion criteria (13 listed)
- Pediatric and adult CF groups
- Unstable metabolic diseases including liver (cirrhosis) or renal disease
- Chronic respiratory failure with cor pulmonale
- Any other condition according to the principle investigator or study physician would interfere with proper conduct of study / safety of the patient
- Failure to give assent / informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ensure plusEnsure plus sip feeds every 20 min during 6 hours. After 2 hour pancreatic enzyme intake in CF | Dietary supplement | Ensure plus |
Primary outcome
Fatty acid absorption during feeding and effect pancreatic enzyme intake
Time frame: 8 hours
Enrichment in palmitic acid and tripalmitin fatty acids in plasma
2 secondary outcomes
Protein digestion during feeding and effect pancreatic enzyme intake
Time frame: 8 hours
Glucose absorption during feeding and effect pancreatic enzyme intake
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Derived from this study: PubMed 24268783Engelen MP, Com G, Anderson PJ, Deutz NE. New stable isotope method to measure protein digestibility and response to pancreatic enzyme intake in cystic fibrosis. Clin Nutr. 2014 Dec;33(6):1024-32. doi: 10.1016/j.clnu.2013.11.004. Epub 2013 Nov 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolaas EP Deutz, MD, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ensure plus in people with Cystic Fibrosis, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatty acid absorption during feeding and effect pancreatic enzyme intake (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01494909, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.