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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oatmeal | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oatmeal | Dietary Supplement | Subjects will be fed a calculated serving of oatmeal. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
5 Male, 5 female
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| Name | Affiliation | Role |
|---|---|---|
| Sean Davies, PhD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Oatmeal: Subjects will be fed a calculated serving of oatmeal. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Serum N-acyl-phosphatidylethanolamine (NAPE) | Change in serum NAPE from baseline to 120 minutes post-oatmeal challenge | Posted | Mean | Standard Error | nmol/L | Baseline to 120 minutes |
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Adverse event data was collected for each participant for 1 study day.
Adverse events used clinical.trials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Oatmeal: Subjects will be fed a calculated serving of oatmeal. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| light-headed / dizziness | Injury, poisoning and procedural complications | Non-systematic Assessment | patient became lightheaded during IV placement, resolved with rest, able to complete study. |
Limitation of this study was that only 1 dose of oatmeal was used and the study group was relatively small.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sean S. Davies | Vanderbilt University | 6153225049 | sean.davies@vanderbilt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 2, 2018 | Sep 10, 2019 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2018 | Sep 10, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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All subjects will have baseline blood drawn, fed controlled serving of oatmeal, and blood drawn sequentially over subsequent 2 hours.
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| baseline 30, 60, 90 and 120 minutes |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Serum NAPE | Serum NAPE Levels at 30, 60, and 90 minutes | Posted | Mean | Standard Deviation | nmol/L | 30, 60, and 90 minutes |
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| Secondary | Serum N-acyl-ethanolamides (NAE) | Serum NAE levels at baseline, 30, 60, 90 and 120 minutes | 5 participants had pre and post NAE levels below the level of detection for reasons that were unclear | Posted | Mean | Standard Error | nmol/L | baseline 30, 60, 90 and 120 minutes |
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| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Title | Measurements |
|---|---|
|
| 90 minutes |
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| 120 minutes |
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