NAPE: Oatmeal Effect on N-acyl-phosphatidylethanolamines

• Sponsor: Vanderbilt University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03468179
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.8
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

N-acyl-phosphatidylethanolamine (NAPEs) and their active metabolites, N-acyl-ethanolamides (NAEs) are lipid satiety factors that are normally biosynthesized in the intestinal tract in response to food intake. Reduced levels of NAPEs and NAEs have been found in obese individuals, and increasing plasma NAPE and NAEs levels may be beneficial to obese individuals trying to lose weight or to keep off weight gain after losing weight. We have found that oatmeal has large amounts of NAPEs, and based on previous mouse studies, we hypothesize that a single dose of dietary oatmeal is sufficient to double plasma NAE from baseline, possibly inducing satiety and increasing basal metabolic rate. To test this hypothesis, we will feed volunteers a single weight-based serving of oatmeal while monitoring its effects on serum glucose, NAPE and NAE levels as well as on subjective satiety.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Cardiovascular Diseases	Dietary Supplement: Oatmeal	N/A

Detailed Description

N-acyl-phosphatidylethanolamine (NAPEs) and their active metabolites, N-acyl-ethanolamides (NAEs) are lipid satiety factors that are normally biosynthesized in the intestinal tract in response to food intake. Reduced levels of NAPEs and NAEs have been found in obese individuals, so that increasing plasma NAPE and NAEs levels may be beneficial to obese individuals trying to lose weight or to keep off weight gain after losing weight. While NAPEs are endogenously synthesized by mammals in their intestinal tract, many other organisms, including plants, also biosynthesize NAPEs. Recent screening of a wide range of foods by our lab demonstrated that oatmeal (Regular Instant Oatmeal) had very large amounts of NAPEs (0.17 mg NAPE / g dry oatmeal), suggesting that consumption of oatmeal may be a straightforward mechanism for elevating plasma NAPE and NAE levels in obese individuals. Based on our previous mouse studies with synthetic NAPE and with bacteria biosynthesizing NAPE, we hypothesize that a dose of oatmeal sufficient to deliver 0.135 mg NAPE per kg body should be sufficient to double plasma NAE levels from baseline, thereby inducing satiety and increasing basal metabolic rate. For a 100 kg person, 80 grams of dry regular instant oatmeal (2 servings) provides this 0.135 mg / kg dose. (The dose of dry oatmeal per person = (body weight in kg / 100 kg)* 80 g dry oatmeal. Thus for 50 kg person, 40 g dry oatmeal (1 serving) provides the required dose.) This amount of dry oatmeal is converted to the test meal by adding sufficient water to overtop oatmeal by about 1 cm (or to consistency desired by volunteer) and then microwaving for ~3-4 minutes on high. In the initial testing, no additives such as butter, cream, or brown sugar should be used in preparation or serving oatmeal. Water can be consumed ad lib.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All subjects will have baseline blood drawn, fed controlled serving of oatmeal, and blood drawn sequentially over subsequent 2 hours.All subjects will have baseline blood drawn, fed controlled serving of oatmeal, and blood drawn sequentially over subsequent 2 hours.
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Acute Effects of Dietary Oatmeal on Serum Levels of N-acyl-phosphatidylethanolamines and Their Metabolites.
• Actual Study Start Date: Oct 7, 2018
• Actual Primary Completion Date: Dec 31, 2018
• Actual Study Completion Date: Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Dietary Supplement: Oatmeal; Subjects will be fed a calculated serving of oatmeal.

Outcome Measures

Primary Outcome Measures

1. Change in Serum N-acyl-phosphatidylethanolamine (NAPE) [Baseline to 120 minutes]

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

Secondary Outcome Measures

1. Serum NAPE [30, 60, and 90 minutes]

   Serum NAPE Levels at 30, 60, and 90 minutes

2. Serum N-acyl-ethanolamides (NAE) [baseline 30, 60, 90 and 120 minutes]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Adult

• non-pregnant

• normal BMI (20-25)

Exclusion Criteria:

• Obese

• underweight

• diabetes mellitus

• coronary artery disease

• oatmeal allergies

• hyper/hypocoagulability

• food intolerances

• Irritable bowel syndrome

• Inflammatory bowel disease

• Celiac disease

• pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

• Vanderbilt University Medical Center

Investigators

• Principal Investigator: Sean Davies, PhD, Vanderbilt University Medical Center

Study Documents (Full-Text)

• Informed Consent Form - Jul 2, 2018
• Study Protocol and Statistical Analysis Plan - Jul 6, 2018

More Information

Publications

None provided.

• Responsible Party: Sean Davies, Associate Professor, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT03468179
• Other Study ID Numbers: JJWPending
• First Posted: Mar 16, 2018
• Last Update Posted: Dec 13, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Sean Davies, Associate Professor, Vanderbilt University Medical Center: Diet; N-acyl-phosphatidylethanolamine; N-acyl-ethanolamine; NAPE; NAE; Oatmeal
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

Participant Flow

Arm/Group Title	Oatmeal
Arm/Group Description	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.
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Oatmeal
Arm/Group Description	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.
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	10 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	5 50%
Male	5 50%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 10%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	9 90%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%

Outcome Measures

1. Primary Outcome

Title	Change in Serum N-acyl-phosphatidylethanolamine (NAPE)
Description	Change in serum NAPE from baseline to 120 minutes post-oatmeal challenge
Time Frame	Baseline to 120 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oatmeal
Arm/Group Description	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.
Measure Participants	10
Mean (Standard Error) [nmol/L]	-4.02 (10.57)

2. Secondary Outcome

Title	Serum NAPE
Description	Serum NAPE Levels at 30, 60, and 90 minutes
Time Frame	30, 60, and 90 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oatmeal
Arm/Group Description	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.
Measure Participants	10
30 minutes	3.36 (7.38)
60 minutes	2.78 (4.17)
90 minutes	4.12 (7.71)

3. Secondary Outcome

Title	Serum N-acyl-ethanolamides (NAE)
Description	Serum NAE levels at baseline, 30, 60, 90 and 120 minutes
Time Frame	baseline 30, 60, 90 and 120 minutes

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Oatmeal
Arm/Group Description	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.
Measure Participants	5
Baseline	0.09 (0.02)
30 minutes	0.08 (0.012)
60 minutes	0.07 (0.013)
90 minutes	0.06 (0.010)
120 minutes	0.07 (0.009)

Adverse Events

Time Frame	Adverse event data was collected for each participant for 1 study day.
Adverse Event Reporting Description	Adverse events used clinical.trials.gov definitions.
Arm/Group Title	Oatmeal
Arm/Group Description	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.
All Cause Mortality
	Oatmeal
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Oatmeal
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Oatmeal
	Affected / at Risk (%)	# Events
Total	1/10 (10%)
Injury, poisoning and procedural complications
light-headed / dizziness	1/10 (10%)	1

Limitations/Caveats

Limitation of this study was that only 1 dose of oatmeal was used and the study group was relatively small.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.