Oatmeal Effect on N-acyl-phosphatidylethanolamines

NCT ID: NCT03468179

Last Updated: 2019-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-07
• Study Completion Date: 2018-12-31

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.

Conditions

Obesity; Cardiovascular Diseases

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Oatmeal

Intervention Type: DIETARY_SUPPLEMENT

Subjects will be fed a calculated serving of oatmeal.

Interventions

Oatmeal

Subjects will be fed a calculated serving of oatmeal.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sean Davies

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sean Davies, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

JJWPending

Identifier Type: -

Identifier Source: org_study_id