Obesity, Cardiovascular Diseases
Conditions
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
Subjects will be fed a calculated serving of oatmeal.
Sponsors
Study design
Intervention model description
All subjects will have baseline blood drawn, fed controlled serving of oatmeal, and blood drawn sequentially over subsequent 2 hours.
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum N-acyl-phosphatidylethanolamine (NAPE) | Baseline to 120 minutes | Change in serum NAPE from baseline to 120 minutes post-oatmeal challenge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum NAPE | 30, 60, and 90 minutes | Serum NAPE Levels at 30, 60, and 90 minutes |
| Serum N-acyl-ethanolamides (NAE) | baseline 30, 60, 90 and 120 minutes | Serum NAE levels at baseline, 30, 60, 90 and 120 minutes |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 10 |
Baseline characteristics
| Characteristic | Oatmeal |
|---|---|
| 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 type | EG000 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
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oatmeal | Change in Serum N-acyl-phosphatidylethanolamine (NAPE) | -4.02 nmol/L | Standard Error 10.57 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oatmeal | Serum N-acyl-ethanolamides (NAE) | Baseline | 0.09 nmol/L | Standard Error 0.02 |
| Oatmeal | Serum N-acyl-ethanolamides (NAE) | 30 minutes | 0.08 nmol/L | Standard Error 0.012 |
| Oatmeal | Serum N-acyl-ethanolamides (NAE) | 60 minutes | 0.07 nmol/L | Standard Error 0.013 |
| Oatmeal | Serum N-acyl-ethanolamides (NAE) | 90 minutes | 0.06 nmol/L | Standard Error 0.01 |
| Oatmeal | Serum N-acyl-ethanolamides (NAE) | 120 minutes | 0.07 nmol/L | Standard Error 0.009 |
Serum NAPE
Serum NAPE Levels at 30, 60, and 90 minutes
Time frame: 30, 60, and 90 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oatmeal | Serum NAPE | 30 minutes | 3.36 nmol/L | Standard Deviation 7.38 |
| Oatmeal | Serum NAPE | 60 minutes | 2.78 nmol/L | Standard Deviation 4.17 |
| Oatmeal | Serum NAPE | 90 minutes | 4.12 nmol/L | Standard Deviation 7.71 |