Trial Outcomes & Findings for Oatmeal Effect on N-acyl-phosphatidylethanolamines (NCT NCT03468179)

NCT ID: NCT03468179

Last Updated: 2019-12-13

Results Overview

Change in serum NAPE from baseline to 120 minutes post-oatmeal challenge

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: Baseline to 120 minutes
• Results posted on: 2019-12-13

Participant Flow

Participant milestones

Measure	Oatmeal Subjects will arrive for study fasting. IV access will be obtained, and baseline blood drawn. They will be fed 80gm/100kg oatmeal, and blood levels will be drawn at 30, 60, 90, and 120 minutes. Oatmeal: Subjects will be fed a calculated serving of oatmeal.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oatmeal Effect on N-acyl-phosphatidylethanolamines

Baseline characteristics by cohort

Measure	Oatmeal n=10 Participants Participants will be fed 80gm/100kg oatmeal, and blood levels will be drawn at 30, 60, 90, and 120 minutes. Oatmeal: Subjects will be fed a calculated serving of oatmeal.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 120 minutes

Change in serum NAPE from baseline to 120 minutes post-oatmeal challenge

Outcome measures

Measure	Oatmeal n=10 Participants Subjects will arrive for study fasting. IV access will be obtained, and baseline blood drawn. They will be fed 80gm/100kg oatmeal, and blood levels will be drawn at 30, 60, 90, and 120 minutes. Oatmeal: Subjects will be fed a calculated serving of oatmeal.
Change in Serum N-acyl-phosphatidylethanolamine (NAPE)	-4.02 nmol/L Standard Error 10.57

SECONDARY outcome

Timeframe: 30, 60, and 90 minutes

Serum NAPE Levels at 30, 60, and 90 minutes

Outcome measures

Measure	Oatmeal n=10 Participants Subjects will arrive for study fasting. IV access will be obtained, and baseline blood drawn. They will be fed 80gm/100kg oatmeal, and blood levels will be drawn at 30, 60, 90, and 120 minutes. Oatmeal: Subjects will be fed a calculated serving of oatmeal.
Serum NAPE 30 minutes	3.36 nmol/L Standard Deviation 7.38
Serum NAPE 60 minutes	2.78 nmol/L Standard Deviation 4.17
Serum NAPE 90 minutes	4.12 nmol/L Standard Deviation 7.71

SECONDARY outcome

Timeframe: baseline 30, 60, 90 and 120 minutes

Population: 5 participants had pre and post NAE levels below the level of detection for reasons that were unclear

Serum NAE levels at baseline, 30, 60, 90 and 120 minutes

Outcome measures

Measure	Oatmeal n=5 Participants Subjects will arrive for study fasting. IV access will be obtained, and baseline blood drawn. They will be fed 80gm/100kg oatmeal, and blood levels will be drawn at 30, 60, 90, and 120 minutes. Oatmeal: Subjects will be fed a calculated serving of oatmeal.
Serum N-acyl-ethanolamides (NAE) Baseline	0.09 nmol/L Standard Error 0.02
Serum N-acyl-ethanolamides (NAE) 30 minutes	0.08 nmol/L Standard Error 0.012
Serum N-acyl-ethanolamides (NAE) 60 minutes	0.07 nmol/L Standard Error 0.013
Serum N-acyl-ethanolamides (NAE) 90 minutes	0.06 nmol/L Standard Error 0.010
Serum N-acyl-ethanolamides (NAE) 120 minutes	0.07 nmol/L Standard Error 0.009

Adverse Events

Oatmeal

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Oatmeal n=10 participants at risk Subjects will arrive for study fasting. IV access will be obtained, and baseline blood drawn. They will be fed 80gm/100kg oatmeal, and blood levels will be drawn at 30, 60, 90, and 120 minutes. Oatmeal: Subjects will be fed a calculated serving of oatmeal.
Injury, poisoning and procedural complications light-headed / dizziness	10.0% 1/10 • Number of events 1 • Adverse event data was collected for each participant for 1 study day. Adverse events used clinical.trials.gov definitions.

Additional Information

Sean S. Davies

Vanderbilt University

Phone: 6153225049

Email: sean.davies@vanderbilt.edu

Results disclosure agreements

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