Oatmeal Effect on N-acyl-phosphatidylethanolamines (NAPE)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Obesity
• Intervention / Treatment: Dietary supplement: Oatmeal

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: March 9, 2018
• First Submitted That Met QC Criteria: March 9, 2018
• First Posted (Actual): March 16, 2018

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: November 25, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Diet; N-acyl-phosphatidylethanolamine; N-acyl-ethanolamine; NAPE; NAE; Oatmeal
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: JJWPending

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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