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Oatmeal Effect on N-acyl-phosphatidylethanolamines

Acute Effects of Dietary Oatmeal on Serum Levels of N-acyl-phosphatidylethanolamines and Their Metabolites.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03468179
Acronym
NAPE
Enrollment
10
Registered
2018-03-16
Start date
2018-10-07
Completion date
2018-12-31
Last updated
2019-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Cardiovascular Diseases

Keywords

Diet, N-acyl-phosphatidylethanolamine, N-acyl-ethanolamine, NAPE, NAE, Oatmeal

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.

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.

Interventions

DIETARY_SUPPLEMENTOatmeal

Subjects will be fed a calculated serving of oatmeal.

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

All subjects will have baseline blood drawn, fed controlled serving of oatmeal, and blood drawn sequentially over subsequent 2 hours.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change in Serum N-acyl-phosphatidylethanolamine (NAPE)Baseline to 120 minutesChange in serum NAPE from baseline to 120 minutes post-oatmeal challenge

Secondary

MeasureTime frameDescription
Serum NAPE30, 60, and 90 minutesSerum NAPE Levels at 30, 60, and 90 minutes
Serum N-acyl-ethanolamides (NAE)baseline 30, 60, 90 and 120 minutesSerum NAE levels at baseline, 30, 60, 90 and 120 minutes

Countries

United States

Participant flow

Participants by arm

ArmCount
Oatmeal
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.
10
Total10

Baseline characteristics

CharacteristicOatmeal
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
9 Participants
Region of Enrollment
United States
10 participants
Sex: Female, Male
Female
5 Participants
Sex: Female, Male
Male
5 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 10
other
Total, other adverse events
1 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

Primary

Change in Serum N-acyl-phosphatidylethanolamine (NAPE)

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

Time frame: Baseline to 120 minutes

ArmMeasureValue (MEAN)Dispersion
OatmealChange in Serum N-acyl-phosphatidylethanolamine (NAPE)-4.02 nmol/LStandard Error 10.57
Secondary

Serum N-acyl-ethanolamides (NAE)

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

Time frame: 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

ArmMeasureGroupValue (MEAN)Dispersion
OatmealSerum N-acyl-ethanolamides (NAE)Baseline0.09 nmol/LStandard Error 0.02
OatmealSerum N-acyl-ethanolamides (NAE)30 minutes0.08 nmol/LStandard Error 0.012
OatmealSerum N-acyl-ethanolamides (NAE)60 minutes0.07 nmol/LStandard Error 0.013
OatmealSerum N-acyl-ethanolamides (NAE)90 minutes0.06 nmol/LStandard Error 0.01
OatmealSerum N-acyl-ethanolamides (NAE)120 minutes0.07 nmol/LStandard Error 0.009
Secondary

Serum NAPE

Serum NAPE Levels at 30, 60, and 90 minutes

Time frame: 30, 60, and 90 minutes

ArmMeasureGroupValue (MEAN)Dispersion
OatmealSerum NAPE30 minutes3.36 nmol/LStandard Deviation 7.38
OatmealSerum NAPE60 minutes2.78 nmol/LStandard Deviation 4.17
OatmealSerum NAPE90 minutes4.12 nmol/LStandard Deviation 7.71

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026