Oatmeal Effect on N-acyl-phosphatidylethanolamines

Not Applicable

Completed

• Conditions: Obesity; Cardiovascular Diseases
• Interventions: Dietary Supplement: Oatmeal

• Registration Number: NCT03468179
• Lead Sponsor: Vanderbilt University Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-03-09
• Study First Posted: 2018-03-16
• Study Start: 2018-10-07
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Results First Submitted: 2019-09-23
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-25
• Last Update Submitted: 2019-11-25
• Results First Posted: 2019-12-13
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Adult
• non-pregnant
• normal BMI (20-25)

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Exclusion Criteria

• Obese
• underweight
• diabetes mellitus
• coronary artery disease
• oatmeal allergies
• hyper/hypocoagulability
• food intolerances
• Irritable bowel syndrome
• Inflammatory bowel disease
• Celiac disease
• pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oatmeal	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Serum N-acyl-ethanolamides (NAE)	baseline 30, 60, 90 and 120 minutes	Serum NAE levels at baseline, 30, 60, 90 and 120 minutes
Serum NAPE	30, 60, and 90 minutes	Serum NAPE Levels at 30, 60, and 90 minutes

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States