Trial Outcomes & Findings for Fat Malabsorption in Chronic Pancreatitis (NCT NCT02849704)

Last Updated: 2019-05-03

Results Overview

The fat absorption pattern in CP subjects will be compared with healthy controls. Mean HA AUC will be calculated for the CP subjects and the healthy controls and compared to determine whether there is a difference in the fat absorption between the two groups.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

48 participants

Primary outcome timeframe

8 hours

Results posted on

2019-05-03

Participant Flow

Subjects were recruited from academic medical centers in the Philadelphia region between August 2016 and November 2017. For the CP cohort, subjects were diagnosed with CP by a gastroenterologist based on criteria as recommended by the American Pancreatic Association (APA) Practice Guidelines.

There were no events between enrollment and assignment in either group. All subjects enrolled were assigned to the appropriate arm.

Participant milestones

Participant milestones
Measure	Chronic Pancreatitis (CP) Subjects CP subjects will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. This visit will be repeated after initiation of Creon36™.	Healthy Controls Healthy controls will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. Controls will only have 1 study visit and receive no intervention.
Washout Period - CP Subj on PERT - 3days STARTED	11	0
Washout Period - CP Subj on PERT - 3days COMPLETED	11	0
Washout Period - CP Subj on PERT - 3days NOT COMPLETED	0	0
Baseline Assessments - All Subj - 7 Days STARTED	24	24
Baseline Assessments - All Subj - 7 Days COMPLETED	24	24
Baseline Assessments - All Subj - 7 Days NOT COMPLETED	0	0
Assessment on PERT - CP Subj - 16 Days STARTED	24	0
Assessment on PERT - CP Subj - 16 Days COMPLETED	21	0
Assessment on PERT - CP Subj - 16 Days NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Chronic Pancreatitis (CP) Subjects CP subjects will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. This visit will be repeated after initiation of Creon36™.	Healthy Controls Healthy controls will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. Controls will only have 1 study visit and receive no intervention.
Assessment on PERT - CP Subj - 16 Days Lost to Follow-up	1	0
Assessment on PERT - CP Subj - 16 Days Adverse Event	1	0
Assessment on PERT - CP Subj - 16 Days Unable to complete study procedures	1	0

Baseline Characteristics

Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 8 hours

Population: Two subjects with CP were excluded; one did not complete the study meal for a valid test, and one was a significant outlier calling into question the validity of the test. Of the 24 healthy controls, two were excluded from the study due to undisclosed chronic disease, and two subjects did not complete the study meal for a valid test.

Outcome measures

Outcome measures
Measure	Chronic Pancreatitis (CP) Subjects n=22 Participants CP subjects will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. This visit will be repeated after initiation of Creon36™.	Healthy Controls n=20 Participants Healthy controls will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. Controls will only have 1 study visit and receive no intervention.
Malabsorption Blood Test: Difference in Mean HA AUC Between Groups: Subjects With CP Compared to Healthy Subjects	8.3 mg*h/dL Standard Deviation 4.3	17.7 mg*h/dL Standard Deviation 10.3

PRIMARY outcome

Timeframe: 72 hours

Population: Four subjects with CP were excluded; two did not consume enough fat for a valid test, one subject did not have adequate stool for analysis, and one subject was excluded due to an error in the lab processing stool. Of the 24 healthy controls, two were excluded from the analysis due to undisclosed chronic disease.

The fat absorption pattern in CP subjects will be compared with healthy controls. Mean coefficient of fat absorption (% dietary fat absorbed) will be calculated for the CP subjects and the healthy controls and compared to determine whether there is a difference in the fat absorption between the two groups.

Outcome measures

Outcome measures
Measure	Chronic Pancreatitis (CP) Subjects n=20 Participants CP subjects will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. This visit will be repeated after initiation of Creon36™.	Healthy Controls n=22 Participants Healthy controls will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. Controls will only have 1 study visit and receive no intervention.
Coefficient of Fat Absorption: Difference in Mean % Dietary Fat Absorption Between Groups: Subjects With CP Compared to Healthy Subjects	90.9 % of dietary fat intake Standard Deviation 12.8	95.4 % of dietary fat intake Standard Deviation 9.3

PRIMARY outcome

Timeframe: 72 hours

Population: Three subjects with CP were excluded; two did not consume enough fat for a valid test, one subject did not have adequate stool for analysis. Of the 24 healthy controls, two were excluded from the analysis due to undisclosed chronic disease, one did not provide adequate stool for analysis, and two results failed internal the validation protocol.

The energy absorption pattern in CP subjects will be compared with healthy controls. Mean calories per gram of stool will be calculated for the CP subjects and the healthy controls and compared to determine whether there is a difference in the stool energy loss between the two groups.

Outcome measures

Outcome measures
Measure	Chronic Pancreatitis (CP) Subjects n=21 Participants CP subjects will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. This visit will be repeated after initiation of Creon36™.	Healthy Controls n=19 Participants Healthy controls will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. Controls will only have 1 study visit and receive no intervention.
Bomb Calorimetry: Difference in Mean Stool Energy Loss Between Groups: Subjects With CP Compared to Healthy Subjects	5728 calories/gram of stool Standard Deviation 717	5171 calories/gram of stool Standard Deviation 393

SECONDARY outcome

Timeframe: 72 hours

Population: Two subjects were excluded from follow-up due to inadequate stool provision. Two subjects were excluded due to failing the internal validation protocol.

The energy absorption pattern in CP subjects before and after treatment with Creon36™ will be compared. Calories per gram of stool will be calculated for the CP subjects before and after the medication and compared to determine whether there is a difference in the stool energy loss in the same subjects between the two time points.

Outcome measures

Outcome measures
Measure	Chronic Pancreatitis (CP) Subjects n=20 Participants CP subjects will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. This visit will be repeated after initiation of Creon36™.	Healthy Controls Healthy controls will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. Controls will only have 1 study visit and receive no intervention.
Bomb Calorimetry: Difference in Mean Energy Loss Between Groups: Subjects With CP Before and After Creon36™	5702 calories/gram of stool Standard Deviation 691	—

SECONDARY outcome

Timeframe: 8 hours

Population: For this paired analysis, twenty subjects had valid tests at both time points. Two subjects were excluded from baseline; one did not complete the study meal for a valid test, and one was a significant outlier calling into question the validity of the test. Two subjects were excluded from follow-up, as they did not complete the study meal or test.

The fat absorption pattern in CP subjects before and after treatment with Creon36™ will be compared. Mean HA AUC will be calculated for the CP subjects before and after the medication and compared to determine whether there is a difference in the fat absorption in the same subjects between the two time points.

Outcome measures

Outcome measures
Measure	Chronic Pancreatitis (CP) Subjects n=20 Participants CP subjects will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. This visit will be repeated after initiation of Creon36™.	Healthy Controls Healthy controls will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. Controls will only have 1 study visit and receive no intervention.
Malabsorption Blood Test: Difference in Mean HA AUC Between Groups: Subjects With CP Before and After Creon36™	9.4 mg*h/dL Standard Deviation 4.2	—

SECONDARY outcome

Timeframe: 72 hours

Population: Two subjects were excluded from baseline due to inadequate dietary fat intake for a valid test, and one was excluded for inadequate stool provision. Three subjects were excluded at follow up for inadequate dietary information and stool provision. One subject was excluded from follow up due to lab error.

The fat absorption pattern in CP subjects before and after treatment with Creon36™ will be compared. The % of dietary fat absorbed will be calculated for the CP subjects before and after the medication and compared to determine whether there is a difference in the fat absorption in the same subjects between the two time points.

Outcome measures

Outcome measures
Measure	Chronic Pancreatitis (CP) Subjects n=17 Participants CP subjects will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. This visit will be repeated after initiation of Creon36™.	Healthy Controls Healthy controls will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. Controls will only have 1 study visit and receive no intervention.
Coefficient of Fat Absorption: Difference in Mean % Dietary Fat Absorption Between Groups: Subjects With CP Before and After Creon36™	93 % of dietary fat intake Standard Deviation 8.8	—

Adverse Events

Chronic Pancreatitis (CP) Subjects

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Healthy Controls

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Chronic Pancreatitis (CP) Subjects n=24 participants at risk CP subjects will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. This visit will be repeated after initiation of Creon36™.	Healthy Controls n=24 participants at risk Healthy controls will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. Controls will only have 1 study visit and receive no intervention.
Gastrointestinal disorders Abdominal Pain/Discomfort	29.2% 7/24 • Number of events 7 • Adverse events were collected for the time period during which study procedures were undertaken. For healthy subjects, this includes the 7 days surrounding the assessment visit. For subjects with CP, this includes the 7 days surrounding the baseline assessment visit and the 9 days during which the subjects took Creon surrounding the second assessment visit. Adverse events were collected by personal interview during the visit itself, and by phone call after the completion of study procedures.	12.5% 3/24 • Number of events 3 • Adverse events were collected for the time period during which study procedures were undertaken. For healthy subjects, this includes the 7 days surrounding the assessment visit. For subjects with CP, this includes the 7 days surrounding the baseline assessment visit and the 9 days during which the subjects took Creon surrounding the second assessment visit. Adverse events were collected by personal interview during the visit itself, and by phone call after the completion of study procedures.

Additional Information

Virginia Stallings, MD

Children's Hospital of Philadelphia

Phone: 267.425.1633

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Chronic Pancreatitis (CP) Subjects n=24 Participants CP subjects will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. This visit will be repeated after initiation of Creon36™.	Healthy Controls n=24 Participants Healthy controls will fast for 12 hours prior to the malabsorption blood test (MBT) testing, consume the MBT breakfast meal following this fast, have blood drawn (MBT, vitamins A, D, E and K, zinc, selenium, and prealbumin) prior to MBT breakfast consumption and each hour for 8 hours after consumption, consume a low-fat study lunch, eat a moderate fat diet for 4 days during home diet and stool collection, maintain a 3-day food record, collect stool over 72 hours, have body size and composition assessment, complete quality of life questionnaires, home environment and health questionnaires, and adverse events diary. Controls will only have 1 study visit and receive no intervention.	Total n=48 Participants Total of all reporting groups
Age, Continuous	50.7 years STANDARD_DEVIATION 9.6 • n=24 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	43.4 years STANDARD_DEVIATION 10 • n=22 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	47.1 years STANDARD_DEVIATION 10.4 • n=46 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.
Sex: Female, Male Female	11 Participants n=24 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	15 Participants n=22 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	26 Participants n=46 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.
Sex: Female, Male Male	13 Participants n=24 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	7 Participants n=22 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	20 Participants n=46 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=24 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	1 Participants n=22 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	2 Participants n=46 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=24 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	21 Participants n=22 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	44 Participants n=46 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=24 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	0 Participants n=22 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	0 Participants n=46 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=24 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	0 Participants n=22 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	0 Participants n=46 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.
Race (NIH/OMB) Asian	2 Participants n=24 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	1 Participants n=22 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	3 Participants n=46 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=24 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	0 Participants n=22 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	0 Participants n=46 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.
Race (NIH/OMB) Black or African American	9 Participants n=24 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	9 Participants n=22 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	18 Participants n=46 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.
Race (NIH/OMB) White	13 Participants n=24 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	12 Participants n=22 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	25 Participants n=46 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.
Race (NIH/OMB) More than one race	0 Participants n=24 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	0 Participants n=22 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	0 Participants n=46 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=24 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	0 Participants n=22 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	0 Participants n=46 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.
BMI	23.9 kg/m^2 STANDARD_DEVIATION 3.6 • n=24 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	25.6 kg/m^2 STANDARD_DEVIATION 4.4 • n=22 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.	24.7 kg/m^2 STANDARD_DEVIATION 4.0 • n=46 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis.
Fecal Elastase	169 ug/g stool STANDARD_DEVIATION 172 • n=24 Participants • This measure was only baseline for the CP group.	—	169 ug/g stool STANDARD_DEVIATION 172 • n=24 Participants • This measure was only baseline for the CP group.
Coefficient of Fat Absorption	90.9 % of dietary fat absorbed STANDARD_DEVIATION 12.8 • n=20 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis. Four subjects with CP did not have adequate stool collection (n=2) or fat intake (n=2) for a valid CFA test.	95.4 % of dietary fat absorbed STANDARD_DEVIATION 9.3 • n=22 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis. Four subjects with CP did not have adequate stool collection (n=2) or fat intake (n=2) for a valid CFA test.	93.2 % of dietary fat absorbed STANDARD_DEVIATION 9.2 • n=42 Participants • Two healthy subjects were found after completion of assessments to have chronic illnesses not initially disclosed upon enrollment. Since they did not meet original inclusion criteria, they were dropped from analysis. Four subjects with CP did not have adequate stool collection (n=2) or fat intake (n=2) for a valid CFA test.
Bomb Calorimetry	5728 cal/g stool STANDARD_DEVIATION 717 • n=21 Participants • 2 healthy subjects were found after assessment to have chronic illnesses not initially disclosed; they were dropped from analysis. 3 subjects were excluded from analysis due to uncertainty in test result (high variability in test runs). 1 subject with CP was excluded due to uncertainty, 2 were excluded due to inadequate stool collection.	5171 cal/g stool STANDARD_DEVIATION 393 • n=19 Participants • 2 healthy subjects were found after assessment to have chronic illnesses not initially disclosed; they were dropped from analysis. 3 subjects were excluded from analysis due to uncertainty in test result (high variability in test runs). 1 subject with CP was excluded due to uncertainty, 2 were excluded due to inadequate stool collection.	5463 cal/g stool STANDARD_DEVIATION 635 • n=40 Participants • 2 healthy subjects were found after assessment to have chronic illnesses not initially disclosed; they were dropped from analysis. 3 subjects were excluded from analysis due to uncertainty in test result (high variability in test runs). 1 subject with CP was excluded due to uncertainty, 2 were excluded due to inadequate stool collection.
HA AUC	8.3 mg*h/dL STANDARD_DEVIATION 4.3 • n=22 Participants • Of the subjects with CP, one did not complete the study meal for a valid test, and one was a significant outlier. Of the healthy subjects, two were deemed not healthy as previously explained, and two did not complete the study meal for a valid test.	17.7 mg*h/dL STANDARD_DEVIATION 10.3 • n=20 Participants • Of the subjects with CP, one did not complete the study meal for a valid test, and one was a significant outlier. Of the healthy subjects, two were deemed not healthy as previously explained, and two did not complete the study meal for a valid test.	12.7 mg*h/dL STANDARD_DEVIATION 9.1 • n=42 Participants • Of the subjects with CP, one did not complete the study meal for a valid test, and one was a significant outlier. Of the healthy subjects, two were deemed not healthy as previously explained, and two did not complete the study meal for a valid test.