An interventional study of Bagel and Potato in Cardiovascular Diseases, Endotoxemia and Endothelial Dysfunction, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-06-15.
Sponsored by Ohio State University · Not applicable, Interventional, and Prevention
This study is focused on assessing potential health benefits of daily consumption of potatoes, specifically its resistant starch content (i.e. nondigestible carbohydrate), on blood vessel and gut health function in adults with metabolic syndrome. It is expected that the daily consumption of potatoes for two weeks, within a diet that follows the Dietary Guidelines for Americans, will improve blood vessel function in association with decreasing gut permeability ("leaky gut") that results in the absorption of bacterial toxins that reside in the intestine. Outcomes will therefore support dietary recommendations for potatoes to support vascular and gastrointestinal health.
Cardiovascular disease is a major public health concern in the United States, where it accounts for 1 in 4 deaths every year. Vascular endothelial dysfunction is an early event leading to cardiovascular disease and can be caused by postprandial hyperglycemia. Cardiovascular disease is also characterized by metabolic endotoxemia. Metabolic endotoxemia describes increased circulating levels of gut-derived endotoxin (lipopolysaccharide; a bacterial product derived from Gram-negative bacteria in the intestines) that results from gut barrier dysfunction, a phenomenon that is common in metabolic syndrome. Studies in animals and humans have shown that consumption of resistant starch (a type of carbohydrate found in potatoes among other foods) can help to improve vascular and gut health. This clinical trial will therefore investigate the extent to which potatoes can improve microbiota composition, alleviate metabolic endotoxemia, and improve vascular function. It is hypothesized that 2-week daily ingestion of potatoes within a diet that meets the Dietary Guidelines for Americans will limit metabolic endotoxemia by decreasing gut barrier permeability and alleviating gut dysbiosis while separately improving vascular function by limiting postprandial hyperglycemia. This study will address the following objectives: 1) define changes in gut barrier function in association with improved gut microbiota composition, increased fecal short chain fatty acid (SCFA) production, and decreased serum endotoxin, 2) define changes in postprandial glycemic responses and endotoxemia, and 3) define changes in gut hormones that promote glycemic control and changes in markers of oxidative stress in relation to improvements in endothelial vascular function, all following 2-week potato consumption. To test the hypothesis, all participants will complete a randomized cross-over trial where they will receive a potato or bagel along with a diet that meets the Dietary Guidelines for Americans for 2 weeks. They will then undergo a 2-h postprandial study to define the influence of potato consumption on vascular function, glycemic control, and endotoxin translocation. Upon completing the intervention, participants will undergo a gut permeability test, fecal samples will be collected for microbiota composition analysis, and blood samples will be collected to assess endotoxin and inflammatory markers. Upon successfully completing this study, it is anticipated that chronic consumption of potatoes will be demonstrated to be an effective dietary strategy to reduce metabolic endotoxemia, improve gut health, and improve vascular function.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's enrollment of 32 is below the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bagel consumed daily for 2 weeks
Other: Bagel
Potato consumed daily for 2 weeks
Other: Potato
A bagel will be consumed daily for 2 weeks.
A potato will be consumed daily for 2 weeks.
Endotoxin
Fasting serum endotoxin concentration
Time frame: Day 14
Vascular Endothelial Function
Area under curve (change from baseline) for brachial artery flow-mediated dilation (FMD). The unit for FMD is %, which is calculated as: \[vessel diameter in millimeters (post-occlusion) - vessel diameter in millimeters (pre-occlusion)\] / vessel diameter in millimeters (pre-occlusion) x 100. FMD(%) is then used to caluclate area under the curve based on independent measures of FMD at 0-120 minutes)
Time frame: Day 14 Postprandial (0, 30, 60, 90, 120 minutes)
Fasting Glucose Day 0
Fasting plasma glucose
Time frame: Fasting glucose on Day 0
Fasting Glucose Day 14
Fasting plasma glucose Day 14
Time frame: Fasting glucose on Day 14
Fasting Insulin Day 0
Fasting plasma insulin
Time frame: Fasting insulin on Day 0
Fasting Insulin Day 14
Fasting plasma insulin Day 14
Time frame: Fasting insulin on Day 14
Postprandial Insulin
Plasma insulin concentration area under curve change from baseline
Time frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Postprandial Glucose
Postprandial plasma glucose concentration area under curve change from baseline
Time frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Fasting Endotoxin
Fasting serum endotoxin concentration
Time frame: Day 0
Postprandial Endotoxin
Postprandial serum endotoxin concentration area under curve change from baseline
Time frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Lactulose/Mannitol Ratio
Urinary concentration of the non-digestible sugars lactulose/mannitol (mg/mg)
Time frame: Day 14, 0-5 hours post-consumption of sugar probes
Sucralose/Erythritol Ratio
Urinary concentration of the non-digestible sugars sucralose/erythritol
Time frame: Day 14, 6-24 hours post-consumption of sugar probes
Fecal Butyrate
Fecal concentration of butyrate
Time frame: Day 14
Fecal Acetate
Fecal concentration of acetate
Time frame: Day 14
Fecal Propionate
Fecal concentration of propionate
Time frame: Day 14
Postprandial Cholecystokinin
Plasma CCK area under curve change from baseline
Time frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Fasting Cholecystokinin
Fasting plasma concentration of CCK
Time frame: Day 14
Postprandial NOx
Plasma total nitrite/nitrate area under curve change from baseline
Time frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Fasting NOx
Fasting plasma concentration of nitrite/nitrate
Time frame: Day 14
Postprandial Malondialdehyde (MDA)
Plasma MDA concentration, biomarker of oxidative stress area under curve change from baseline
Time frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Fasting Malondialdehyde (MDA)
Fasting plasma MDA concentration, biomarker of oxidative stress
Time frame: Day 14
Fasting Vascular Endothelial Function
Fasting flow-mediated dilation of the brachial artery. Measure is calculated as: \[post-occlusion vessel diameter (mm) - pre-occlusion vessel diameter (mm) / pre-occlusion vessel diameter (mm)\] x 100
Time frame: Day 14
Vitamin C
Fasting vitamin C concentration, biomarker of oxidative stress
Time frame: Day 14
cIMT
Carotid intima-media thickness. Mean thickness of left and right carotid artery intima media.
Time frame: Day 14
Day 14 BMI
Body mass index calculated as kg weight per meters squared
Time frame: Day 14
Day 0 Waist Circumference
Waist circumference in centimeters
Time frame: Day 0
Day 14 Waist Circumference
Waist circumference in centimeters
Time frame: Day 14
Day 0 Diastolic Blood Pressure
Diastolic blood pressure on Day 0
Time frame: Day 0
Day 14 Diastolic Blood Pressure
Diastolic blood pressure on Day 14
Time frame: Day 14
Day 0 Systolic Blood Pressure
Systolic blood pressure on Day 0
Time frame: Day 0
Day 14 Systolic Blood Pressure
Systolic blood pressure on Day 14
Time frame: Day 14
Day 0 BMI
Body mass index calculated as kg weight per meters squared
Time frame: Day 0
| Milestone | Bagel Diet First and Potato Diet | Potato Diet First and Bagel Diet |
|---|---|---|
| Started | 20 | 12 |
| Completed | 19 | 10 |
| Not completed | 1 | 2 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Milestone | Bagel Diet First and Potato Diet | Potato Diet First and Bagel Diet |
|---|---|---|
| Started | 19 | 10 |
| Completed | 19 | 10 |
| Not completed | 0 | 0 |
| Milestone | Bagel Diet First and Potato Diet | Potato Diet First and Bagel Diet |
|---|---|---|
| Started | 19 | 10 |
| Completed | 18 | 9 |
| Not completed | 1 | 1 |
| Withdrew: Protocol violation | 1 | 1 |
Fasting serum endotoxin concentration
| EU/mL | Bagel Diet | Potato Diet |
|---|---|---|
| Endotoxin | 21.2 ± 3.0 | 23.3 ± 3.0 |
Area under curve (change from baseline) for brachial artery flow-mediated dilation (FMD). The unit for FMD is %, which is calculated as: \[vessel diameter in millimeters (post-occlusion) - vessel diameter in millimeters (pre-occlusion)\] / vessel diameter in millimeters (pre-occlusion) x 100. FMD(%) is then used to caluclate area under the curve based on independent measures of FMD at 0-120 minutes)
| % x min | Bagel Diet | Potato Diet |
|---|---|---|
| Vascular Endothelial Function | -259 ± 75 | -198 ± 71 |
Fasting plasma glucose
| mg/dL | Bagel Diet | Potato Diet |
|---|---|---|
| Fasting Glucose Day 0 | 104 ± 13.5 | 109.5 ± 14.6 |
Fasting plasma glucose Day 14
| mg/dL | Bagel Diet | Potato Diet |
|---|---|---|
| Fasting Glucose Day 14 | 101.9 ± 12.3 | 102.3 ± 13.5 |
Fasting plasma insulin
| uIU/mL | Bagel Diet | Potato Diet |
|---|---|---|
| Fasting Insulin Day 0 | 21.1 ± 5.5 | 17.0 ± 2.0 |
Fasting plasma insulin Day 14
| uIU/mL | Bagel Diet | Potato Diet |
|---|---|---|
| Fasting Insulin Day 14 | 14.2 ± 2.0 | 14.9 ± 2.4 |
Plasma insulin concentration area under curve change from baseline
| uIU/mL x min | Bagel Diet | Potato Diet |
|---|---|---|
| Postprandial Insulin | 5940 ± 670 | 7086 ± 1372 |
Postprandial plasma glucose concentration area under curve change from baseline
| mg/dL x min | Bagel Diet | Potato Diet |
|---|---|---|
| Postprandial Glucose | 2649 ± 499 | 2808 ± 565 |
Fasting serum endotoxin concentration
| EU/mL | Bagel Diet | Potato Diet |
|---|---|---|
| Fasting Endotoxin | 26.6 ± 2.0 | 22.3 ± 2.1 |
Postprandial serum endotoxin concentration area under curve change from baseline
| EU/ml x min | Bagel Diet | Potato Diet |
|---|---|---|
| Postprandial Endotoxin | 450 ± 249 | -120 ± 176 |
Urinary concentration of the non-digestible sugars lactulose/mannitol (mg/mg)
| Ratio (mg/mg) | Bagel Diet | Potato Diet |
|---|---|---|
| Lactulose/Mannitol Ratio | .154 ± .013 | .151 ± 0.1 |
Urinary concentration of the non-digestible sugars sucralose/erythritol
| Ratio (mg/mg) | Bagel Diet | Potato Diet |
|---|---|---|
| Sucralose/Erythritol Ratio | .0148 ± 0.002 | 0.01667 ± 0.001925 |
Fecal concentration of butyrate
| umol/g | Bagel Diet | Potato Diet |
|---|---|---|
| Fecal Butyrate | 21.3 ± 2.7 | 17.9 ± 2.6 |
Fecal concentration of acetate
| umol/g | Bagel Diet | Potato Diet |
|---|---|---|
| Fecal Acetate | 52.3 ± 4.7 | 46.6 ± 3.9 |
Fecal concentration of propionate
| umol/g | Bagel Diet | Potato Diet |
|---|---|---|
| Fecal Propionate | 23.1 ± 2.2 | 19.3 ± 2.1 |
Plasma CCK area under curve change from baseline
| pmol/L x min | Bagel Diet | Potato Diet |
|---|---|---|
| Postprandial Cholecystokinin | -196 ± 266 | -67 ± 344 |
Fasting plasma concentration of CCK
| pmol/L | Bagel Diet | Potato Diet |
|---|---|---|
| Fasting Cholecystokinin | 14.3 ± 3.1 | 14.2 ± 3.4 |
Plasma total nitrite/nitrate area under curve change from baseline
| umol/L x min | Bagel Diet | Potato Diet |
|---|---|---|
| Postprandial NOx | -240 ± 88 | -433 ± 48 |
Fasting plasma concentration of nitrite/nitrate
| umol/L x min | Bagel Diet | Potato Diet |
|---|---|---|
| Fasting NOx | 29.8 ± 3.7 | 30.1 ± 2.3 |
Plasma MDA concentration, biomarker of oxidative stress area under curve change from baseline
| umol/L x min | Bagel Diet | Potato Diet |
|---|---|---|
| Postprandial Malondialdehyde (MDA) | 57.2 ± 6.8 | 45.4 ± 7.2 |
Fasting plasma MDA concentration, biomarker of oxidative stress
| umol/L | Bagel Diet | Potato Diet |
|---|---|---|
| Fasting Malondialdehyde (MDA) | 1.78 ± .1 | 1.93 ± .1 |
Fasting flow-mediated dilation of the brachial artery. Measure is calculated as: \[post-occlusion vessel diameter (mm) - pre-occlusion vessel diameter (mm) / pre-occlusion vessel diameter (mm)\] x 100
| % change in blood vessel dilation | Bagel Diet | Potato Diet |
|---|---|---|
| Fasting Vascular Endothelial Function | 7.2 ± 1.3 | 8.7 ± 1.3 |
Fasting vitamin C concentration, biomarker of oxidative stress
| umol/L | Bagel Diet | Potato Diet |
|---|---|---|
| Vitamin C | 47.5 ± 2.9 | 52.5 ± 4.8 |
Carotid intima-media thickness. Mean thickness of left and right carotid artery intima media.
| mm | Bagel Diet | Potato Diet |
|---|---|---|
| cIMT | 0.603 ± 0.109 | 0.609 ± 0.114 |
Body mass index calculated as kg weight per meters squared
| kg/m^2 | Bagel Diet | Potato Diet |
|---|---|---|
| Day 14 BMI | 35.1 ± 1.1 | 35.2 ± 1.1 |
Waist circumference in centimeters
| cm | Bagel Diet | Potato Diet |
|---|---|---|
| Day 0 Waist Circumference | 108.5 ± 2.2 | 119.1 ± 2.2 |
Waist circumference in centimeters
| mmHg | Bagel Diet | Potato Diet |
|---|---|---|
| Day 14 Waist Circumference | 107.8 ± 2.4 | 107.5 ± 2.4 |
Diastolic blood pressure on Day 0
| mmHg | Bagel Diet | Potato Diet |
|---|---|---|
| Day 0 Diastolic Blood Pressure | 81.5 ± 1.3 | 81.9 ± 1.5 |
Diastolic blood pressure on Day 14
| mmHg | Bagel Diet | Potato Diet |
|---|---|---|
| Day 14 Diastolic Blood Pressure | 75.9 ± 1.7 | 77.7 ± 1.4 |
Systolic blood pressure on Day 0
| mmHg | Bagel Diet | Potato Diet |
|---|---|---|
| Day 0 Systolic Blood Pressure | 123.1 ± 1.9 | 119.1 ± 2.2 |
Systolic blood pressure on Day 14
| mmHg | Bagel Diet | Potato Diet |
|---|---|---|
| Day 14 Systolic Blood Pressure | 113.6 ± 1.9 | 114.6 ± 1.8 |
Body mass index calculated as kg weight per meters squared
| kg/m^2 | Bagel Diet | Potato Diet |
|---|---|---|
| Day 0 BMI | 35.6 ± 1.2 | 35.7 ± 1.2 |
Collected over Participation in this cross-over study for each subject was approximately 8 weeks in duration.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bagel Diet | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Potato Diet | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Age, Continuous(years) | Baseline Measures - All Participants |
|---|---|
| Mean | 32.5 ± 6.8 |
| Sex: Female, Male(Participants) | Baseline Measures - All Participants |
|---|---|
| Female | 14 |
| Male | 13 |
| Race and Ethnicity Not Collected(Participants) | Baseline Measures - All Participants |
|---|
| Region of Enrollment(participants) | Baseline Measures - All Participants |
|---|---|
| United States | 27 |
| Body mass index (kg/m^2)(kg/m^2) | Baseline Measures - All Participants |
|---|---|
| Mean | 35 ± 5.1 |
| Waist Circumference (cm)(cm) | Baseline Measures - All Participants |
|---|---|
| Mean | 109.8 ± 12.2 |
| Systolic Blood Pressure (mmHg)(mmHg) | Baseline Measures - All Participants |
|---|---|
| Mean | 120.5 ± 8.4 |
| Diastolic Blood Pressure (mmHg)(mmHg) | Baseline Measures - All Participants |
|---|---|
| Mean | 82.9 ± 5.6 |
4 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Data will be published as aggregate only. Data sharing may be possible pending institutional agreements.
This study is completed, as verified in Jun 2025. 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.