An interventional study of Oatmeal in Obesity and Cardiovascular Diseases, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-13.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Basic science
Among 40 studies in Obesity by Vanderbilt University Medical Center — 7 open to participants now, 12 under way, 1 of them phase 3. Obesity · Vanderbilt University Medical Center.
Among the 40 studies in Obesity by Vanderbilt University Medical Center, this one is the 27th largest by enrollment of the 33 interventional ones that give a count, is one of 4 that started in 2018, is one of 9 with no phase, and was the 22nd registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 10 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →7 of the 40 studies in Obesity by Vanderbilt University Medical Center are open now, in 1 country. Each count lists the studies.
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →40 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 15 · Phase 3 1 · Phase 4 1
First in 2005; this study’s year is marked. 4 started in 2018.
Median enrollment 29 across the 33 interventional studies, 75 across the 7 observational. Of the 24 that completed or were terminated, 12 (50%) have results posted.
Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 155 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.
4 of the studies in Obesity by Vanderbilt University Medical Center that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03318094Vanderbilt University Medical CenterRole of Sympathetic Vasoconstriction on Insulin-Mediated Microvascular Recruitment and Glucose Uptake in Obesity | 2026-11-30 |
| NCT07115069Vanderbilt University Medical CenterComparison of Body Composition Changes With Weight Loss Interventions | 2027-06 |
| NCT05972564Vanderbilt University Medical CenterThe Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function | 2027-06-30 |
| NCT07011628Vanderbilt University Medical CenterTransition to Ambulatory Bariatric Surgery (TABS) Trial | 2027-10-01 |
Among the 40 studies in Obesity by Vanderbilt University Medical Center, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Serum NAPE
Serum NAPE Levels at 30, 60, and 90 minutes
Time frame: 30, 60, and 90 minutes
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
| Milestone | Oatmeal |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
Change in serum NAPE from baseline to 120 minutes post-oatmeal challenge
| nmol/L | Oatmeal |
|---|---|
| Change in Serum N-acyl-phosphatidylethanolamine (NAPE) | -4.02 ± 10.57 |
Serum NAPE Levels at 30, 60, and 90 minutes
| nmol/L | Oatmeal |
|---|---|
| 30 minutes | 3.36 ± 7.38 |
| 60 minutes | 2.78 ± 4.17 |
| 90 minutes | 4.12 ± 7.71 |
Serum NAE levels at baseline, 30, 60, 90 and 120 minutes
| nmol/L | Oatmeal |
|---|---|
| Baseline | 0.09 ± 0.02 |
| 30 minutes | 0.08 ± 0.012 |
| 60 minutes | 0.07 ± 0.013 |
| 90 minutes | 0.06 ± 0.010 |
| 120 minutes | 0.07 ± 0.009 |
Collected over Adverse event data was collected for each participant for 1 study day.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oatmeal | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) |
| Event | Oatmeal |
|---|---|
| light-headed / dizzinessInjury, poisoning and procedural complications | 1/10 |
| Age, Categorical(Participants) | Oatmeal |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Oatmeal |
|---|---|
| Female | 5 |
| Male | 5 |
| Race (NIH/OMB)(Participants) | Oatmeal |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 9 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Oatmeal |
|---|---|
| United States | 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2018 to primary completion in Dec 2018, 2 months.
Results were first posted in Dec 2019, 11 months after primary completion.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 2 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Oatmeal
Vanderbilt University Medical Center →