Trial Outcomes & Findings for Cardiometabolic Effects of Pecans as a Snack (NCT NCT05071807)

NCT ID: NCT05071807

Last Updated: 2025-02-25

Results Overview

Measured by brachial ultrasound and expressed as percentage points of change in arterial diameter

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 138 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2025-02-25

Participant Flow

Participant milestones

Measure	Pecan Group Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.	Usual Care Group Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.
Overall Study STARTED	69	69
Overall Study COMPLETED	62	68
Overall Study NOT COMPLETED	7	1

Reasons for withdrawal

Measure	Pecan Group Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.	Usual Care Group Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.
Overall Study Withdrawal by Subject	4	0
Overall Study Unrelated medical issues	3	0
Overall Study Relocated	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Pecan Group n=69 Participants Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.	Usual Care Group n=69 Participants Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.	Total n=138 Participants Total of all reporting groups
Age, Continuous	46 years STANDARD_DEVIATION 12 • n=69 Participants	46 years STANDARD_DEVIATION 14 • n=69 Participants	46 years STANDARD_DEVIATION 13 • n=138 Participants
Sex: Female, Male Female	45 Participants n=69 Participants	36 Participants n=69 Participants	81 Participants n=138 Participants
Sex: Female, Male Male	24 Participants n=69 Participants	33 Participants n=69 Participants	57 Participants n=138 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	69 participants n=69 Participants	69 participants n=69 Participants	138 participants n=138 Participants
Weight	84.3 kg STANDARD_DEVIATION 12.5 • n=69 Participants	85.2 kg STANDARD_DEVIATION 14.3 • n=69 Participants	84.8 kg STANDARD_DEVIATION 13.4 • n=138 Participants
Waist circumference	97.2 cm STANDARD_DEVIATION 8.8 • n=69 Participants	98.8 cm STANDARD_DEVIATION 10.8 • n=69 Participants	98.0 cm STANDARD_DEVIATION 9.9 • n=138 Participants
Pulse wave velocity	7.1 m/s STANDARD_DEVIATION 1.3 • n=69 Participants	7.2 m/s STANDARD_DEVIATION 1.2 • n=69 Participants	7.2 m/s STANDARD_DEVIATION 1.3 • n=138 Participants
Flow mediated dilation	7.2 percent point change in arterial diamete STANDARD_DEVIATION 4.0 • n=69 Participants	6.1 percent point change in arterial diamete STANDARD_DEVIATION 3.3 • n=69 Participants	6.6 percent point change in arterial diamete STANDARD_DEVIATION 3.7 • n=138 Participants
LDL-C	118 mg/dL STANDARD_DEVIATION 34 • n=69 Participants	116 mg/dL STANDARD_DEVIATION 28 • n=69 Participants	117 mg/dL STANDARD_DEVIATION 31 • n=138 Participants
HDL-C	54 mmHg STANDARD_DEVIATION 14 • n=69 Participants	52 mmHg STANDARD_DEVIATION 13 • n=69 Participants	53 mmHg STANDARD_DEVIATION 13.4 • n=138 Participants
Triglycerides	109 mmHg STANDARD_DEVIATION 67 • n=69 Participants	116 mmHg STANDARD_DEVIATION 47 • n=69 Participants	113 mmHg STANDARD_DEVIATION 58 • n=138 Participants
LDL subclasses Large	373 nmol/L STANDARD_DEVIATION 251 • n=69 Participants	329 nmol/L STANDARD_DEVIATION 194 • n=69 Participants	351 nmol/L STANDARD_DEVIATION 225 • n=138 Participants
LDL subclasses Medium	366 nmol/L STANDARD_DEVIATION 267 • n=69 Participants	312 nmol/L STANDARD_DEVIATION 255 • n=69 Participants	339 nmol/L STANDARD_DEVIATION 261 • n=138 Participants
LDL subclasses Small	623 nmol/L STANDARD_DEVIATION 435 • n=69 Participants	698 nmol/L STANDARD_DEVIATION 353 • n=69 Participants	660 nmol/L STANDARD_DEVIATION 396 • n=138 Participants
LDL subclasses Total LDL particle count	1362 nmol/L STANDARD_DEVIATION 399 • n=69 Participants	1339 nmol/L STANDARD_DEVIATION 339 • n=69 Participants	1350 nmol/L STANDARD_DEVIATION 396 • n=138 Participants
HDL subclasses Large	2.5 µmol/L STANDARD_DEVIATION 1.7 • n=69 Participants	2.3 µmol/L STANDARD_DEVIATION 1.4 • n=69 Participants	2.4 µmol/L STANDARD_DEVIATION 1.6 • n=138 Participants
HDL subclasses Medium	4.0 µmol/L STANDARD_DEVIATION 1.8 • n=69 Participants	4.4 µmol/L STANDARD_DEVIATION 2.4 • n=69 Participants	4.2 µmol/L STANDARD_DEVIATION 2.1 • n=138 Participants
HDL subclasses Small	14.2 µmol/L STANDARD_DEVIATION 2.8 • n=69 Participants	14.0 µmol/L STANDARD_DEVIATION 3.4 • n=69 Participants	14.1 µmol/L STANDARD_DEVIATION 3.1 • n=138 Participants
HDL subclasses HDL total particle count	20.7 µmol/L STANDARD_DEVIATION 2.6 • n=69 Participants	20.6 µmol/L STANDARD_DEVIATION 2.9 • n=69 Participants	20.7 µmol/L STANDARD_DEVIATION 2.7 • n=138 Participants
Brachial blood pressure Systolic	124 mmHg STANDARD_DEVIATION 15 • n=69 Participants	125 mmHg STANDARD_DEVIATION 11 • n=69 Participants	124 mmHg STANDARD_DEVIATION 13 • n=138 Participants
Brachial blood pressure Diastolic	79 mmHg STANDARD_DEVIATION 8 • n=69 Participants	79 mmHg STANDARD_DEVIATION 10 • n=69 Participants	79 mmHg STANDARD_DEVIATION 9 • n=138 Participants
Central blood pressure Systolic	114 mmHg STANDARD_DEVIATION 14 • n=69 Participants	114 mmHg STANDARD_DEVIATION 14 • n=69 Participants	114 mmHg STANDARD_DEVIATION 12 • n=138 Participants
Central blood pressure Diastolic	79 mmHg STANDARD_DEVIATION 10 • n=69 Participants	80 mmHg STANDARD_DEVIATION 8 • n=69 Participants	80 mmHg STANDARD_DEVIATION 9 • n=138 Participants
Augmentation index @ 75bpm	22 percentage of aortic pulse pressure STANDARD_DEVIATION 11 • n=69 Participants	21 percentage of aortic pulse pressure STANDARD_DEVIATION 13 • n=69 Participants	22 percentage of aortic pulse pressure STANDARD_DEVIATION 12 • n=138 Participants
Plasma glucose	97 mg/dL STANDARD_DEVIATION 7 • n=69 Participants	98 mg/dL STANDARD_DEVIATION 8 • n=69 Participants	98 mg/dL STANDARD_DEVIATION 7.4 • n=138 Participants
Serum insulin	9.4 μIU/mL STANDARD_DEVIATION 5.0 • n=69 Participants	8.8 μIU/mL STANDARD_DEVIATION 3.5 • n=69 Participants	9.1 μIU/mL STANDARD_DEVIATION 4.3 • n=138 Participants
HbA1C	5.5 percentage of glycated hemoglobin STANDARD_DEVIATION 0.3 • n=69 Participants	5.5 percentage of glycated hemoglobin STANDARD_DEVIATION 0.3 • n=69 Participants	5.5 percentage of glycated hemoglobin STANDARD_DEVIATION 0.3 • n=138 Participants
Diet quality: Healthy Eating Index 2020	57.2 scores on a scale STANDARD_DEVIATION 13.4 • n=69 Participants	55.1 scores on a scale STANDARD_DEVIATION 10.7 • n=69 Participants	56.1 scores on a scale STANDARD_DEVIATION 12.1 • n=138 Participants
Total Cholesterol concentration	194 mg/dL STANDARD_DEVIATION 39 • n=69 Participants	190 mg/dL STANDARD_DEVIATION 32 • n=69 Participants	192 mg/dL STANDARD_DEVIATION 36 • n=138 Participants

PRIMARY outcome

Timeframe: 12 weeks

Measured by brachial ultrasound and expressed as percentage points of change in arterial diameter

Outcome measures

Measure	Pecan Group n=62 Participants Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.	Usual Care Group n=67 Participants Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.
Flow Mediated Dilation	7.07 percent point change in arterial diamete Standard Error 0.35	7.25 percent point change in arterial diamete Standard Error 0.33

SECONDARY outcome

Timeframe: 12 weeks

Assessed from fasting blood draw expressed in mg/dL

Outcome measures

Measure	Pecan Group n=62 Participants Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.	Usual Care Group n=68 Participants Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.
LDL-cholesterol Concentration	110 mg/dL Standard Error 1.35	117 mg/dL Standard Error 1.26

SECONDARY outcome

Timeframe: 12 weeks

Assessed from fasting blood draw expressed in mg/dL

Outcome measures

Measure	Pecan Group n=62 Participants Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.	Usual Care Group n=68 Participants Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.
HDL-cholesterol Concentration	54 mg/dL Standard Error 0.47	53 mg/dL Standard Error 0.44

SECONDARY outcome

Timeframe: 12 weeks

Assessed from fasting blood draw expressed in mg/dL

Outcome measures

Measure	Pecan Group n=62 Participants Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.	Usual Care Group n=68 Participants Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.
Triglycerides	97.7 mg/dL Interval 92.6 to 103.0	108 mg/dL Interval 103.0 to 114.0

SECONDARY outcome

Timeframe: 12 weeks

Assessed from fasting blood draw expressed in nmol/L. Data were log transformed and back transformed to improve residual distribution; Measure Description: LDL particle size classifications are as follows: 22-25.5 nm is small, 25.6-26.5 nm medium, and 26.6-28.5 nm large. Typically, smaller LDL is associated with increased cardiovascular risk compared to larger.

Outcome measures

Measure	Pecan Group n=62 Participants Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.	Usual Care Group n=68 Participants Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.
LDL Lipoprotein Subclasses Large	281 nmol/L Interval 249.0 to 317.0	252 nmol/L Interval 225.0 to 281.0
LDL Lipoprotein Subclasses Total	1248 nmol/L Interval 1216.0 to 1280.0	1304 nmol/L Interval 1273.0 to 1336.0

SECONDARY outcome

Timeframe: 12 weeks

Assessed from fasting blood draw expressed in µmol/L; Measure Description: Size classifications of HDL subclasses are as follows: large (size 9.4-14.0 nm), medium (8.3-9.3 nm), and small (7.3-8.2 nm). Higher levels of large HDL may be inversely related to cardiovascular risk.

Outcome measures

Measure	Pecan Group n=62 Participants Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.	Usual Care Group n=68 Participants Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.
HDL Lipoprotein Subclasses Medium	4.1 μmol/L Standard Error 0.1	4.4 μmol/L Standard Error 0.1
HDL Lipoprotein Subclasses Small	14.1 μmol/L Standard Error 0.2	14.3 μmol/L Standard Error 0.2
HDL Lipoprotein Subclasses Total	21.0 μmol/L Standard Error 0.17	21.0 μmol/L Standard Error 0.16

SECONDARY outcome

Timeframe: 12 weeks

Blood pressure measured assessed using a SphygmoCor Xcel (Atcor Medical)

Outcome measures

Measure	Pecan Group n=62 Participants Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.	Usual Care Group n=68 Participants Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.
Brachial Systolic and Diastolic Blood Pressure Systolic	125 mmHg Standard Error 0.81	125 mmHg Standard Error 0.77
Brachial Systolic and Diastolic Blood Pressure Diastolic	79 mmHg Standard Error 0.50	79 mmHg Standard Error 0.47

SECONDARY outcome

Timeframe: 12 weeks

Blood pressure measured assessed using a SphygmoCor Xcel (Atcor Medical)

Outcome measures

Measure	Pecan Group n=62 Participants Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.	Usual Care Group n=68 Participants Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.
Central Systolic and Diastolic Blood Pressure Systolic	114 mmHg Standard Error 0.70	115 mmHg Standard Error 0.69
Central Systolic and Diastolic Blood Pressure Diastolic	80 mmHg Standard Error 0.50	80 mmHg Standard Error 0.48

SECONDARY outcome

Timeframe: 12 weeks

A measure of arterial stiffness assessed using a SphygmoCor Xcel (Atcor Medical). Expressed in meters/second. Higher values indicate greater arterial stiffness

Outcome measures

Measure	Pecan Group n=62 Participants Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.	Usual Care Group n=68 Participants Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.
Carotid-femoral Pulse Wave Velocity	7.1 m/s Standard Deviation 1.3	7.3 m/s Standard Deviation 1.3

SECONDARY outcome

Timeframe: 12 weeks

A measure of arterial stiffness assessed using a SphygmoCor Xcel (Atcor Medical). Expressed as a percentage. A higher percentage value is indicative of greater arterial stiffness. Measure Description: Augmentation index is a measure of arterial stiffening that correlates with CVD risk. Higher augmentation index, used as a surrogate for wave reflection, is indicative of additional load on the left ventricle. Augmentation index is calculated as augmentation pressure/pulse pressure*100 to provide a percent. We utilized the Sphymocor Xcel for this measure. We used standardized augmentation index at 75 bpm for heart rate.

Outcome measures

Measure	Pecan Group n=62 Participants Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.	Usual Care Group n=68 Participants Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.
Augmentation Index@75bpm	21 percentage of aortic pulse pressure Standard Error 0.65	22 percentage of aortic pulse pressure Standard Error 0.65

SECONDARY outcome

Timeframe: 12 weeks

Fasting blood glucose assessed by blood draw and expressed in mg/dL

Outcome measures

Measure	Pecan Group n=62 Participants Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.	Usual Care Group n=68 Participants Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.
Fasting Plasma Glucose Concentration	97.7 mg/dL Standard Error 0.48	96.7 mg/dL Standard Error 0.45

SECONDARY outcome

Timeframe: 12 weeks

Fasting serum insulin levels assessed by blood draw and expressed in micro IU/m

Outcome measures

Measure	Pecan Group n=62 Participants Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.	Usual Care Group n=68 Participants Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.
Serum Insulin Concentration	8.42 μIU/mL Interval 7.92 to 8.95	8.33 μIU/mL Interval 7.87 to 8.83

SECONDARY outcome

Timeframe: 12-weeks

HbA1c assessed in whole blood collected during fasting

Outcome measures

Measure	Pecan Group n=62 Participants Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.	Usual Care Group n=68 Participants Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.
HbA1c	5.53 percentage of glycated hemoglobin Standard Error 0.01	5.49 percentage of glycated hemoglobin Standard Error 0.01

SECONDARY outcome

Timeframe: 12-weeks

Diet quality measured by 24-hour recalls will be assessed using Health Eating Index 2020 (HEI-2020) scores range from 0-100 with 100 indicating perfect adherence to dietary guidelines and 0 indicating no adherence. The HEI-2020 includes 13 components; 9 components are adequacy (i.e., consuming more results in a higher score), and 4 are moderation (i.e., consuming less results in a higher score). The HEI-2020 was calculated with the Statistical Analysis System (SAS) code from the National Cancer Institute.

Outcome measures

Measure	Pecan Group n=65 Participants Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.	Usual Care Group n=67 Participants Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.
Diet Quality: Healthy Eating Index 2020	60.8 scores on a scale Standard Error 1.1	51.5 scores on a scale Standard Error 1.0

SECONDARY outcome

Timeframe: 12-weeks

Assessed from fasting blood draw expressed in mg/dL

Outcome measures

Measure	Pecan Group n=62 Participants Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.	Usual Care Group n=68 Participants Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.
Total Cholesterol Concentration	185 mg/dL Standard Error 1.69	193 mg/dL Standard Error 1.59

SECONDARY outcome

Timeframe: 12 weeks

LDL subclasses with normal distribution; Measure Description: LDL particle size classifications are as follows: 22-25.5 nm is small, 25.6-26.5 nm medium, and 26.6-28.5 nm large. Typically, smaller LDL is associated with increased cardiovascular risk compared to larger.

Outcome measures

Measure	Pecan Group n=62 Participants Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.	Usual Care Group n=68 Participants Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.
LDL Subclasses Medium	297 nmol/L Standard Error 20.2	337 nmol/L Standard Error 19.1
LDL Subclasses Small	684 nmol/L Standard Error 24.5	677 nmol/L Standard Error 23.2

SECONDARY outcome

Timeframe: 12 weeks

Measure was log transformed and back transformed to improve distribution; results for large HDL subclass are presented; Measure Description: Size classifications of HDL subclasses are as follows: large (size 9.4-14.0 nm), medium (8.3-9.3 nm), and small (7.3-8.2 nm). Higher levels of large HDL may be inversely related to cardiovascular risk.

Outcome measures

Measure	Pecan Group n=62 Participants Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.	Usual Care Group n=68 Participants Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.
HDL Subclass-Large	2.2 μmol/L Interval 2.0 to 2.3	2.0 μmol/L Interval 1.8 to 2.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Abundance measured using 16 s rRNA sequencing

Outcome measures

Outcome data not reported

Adverse Events

Pecan Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Usual Care Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pecan Group n=69 participants at risk Participants will consume their usual diet, but replace one snack with unsalted raw pecans incorporated as a snack Pecans: Participants will receive 2 oz of pecans daily to replace a typical snack and continue consuming their usual diet for 12 weeks.	Usual Care Group n=69 participants at risk Participants will consume their usual diet devoid of nuts Usual Care: Participants will receive grocery vouchers and continue consuming their usual diet for 12 weeks.
Gastrointestinal disorders Appendectomy	1.4% 1/69 • Number of events 1 • 3 months No deaths occurred no serious adverse events occurred.	0.00% 0/69 • 3 months No deaths occurred no serious adverse events occurred.
Gastrointestinal disorders Gastric resection	1.4% 1/69 • Number of events 1 • 3 months No deaths occurred no serious adverse events occurred.	0.00% 0/69 • 3 months No deaths occurred no serious adverse events occurred.

Additional Information

DCH Lab

Penn State University

Phone: 8148638056

Email: dchlab@psu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place