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| Name | Class |
|---|---|
| Alliance for Potato Research and Education | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bagel diet | Sham Comparator | Bagel consumed daily for 2 weeks |
|
| Potato diet | Experimental | Potato consumed daily for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bagel | Other | A bagel will be consumed daily for 2 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Endotoxin | Fasting serum endotoxin concentration | 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) | Day 14 Postprandial (0, 30, 60, 90, 120 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Glucose Day 0 | Fasting plasma glucose | Fasting glucose on Day 0 |
| Fasting Glucose Day 14 | Fasting plasma glucose Day 14 | Fasting glucose on Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Bruno, PhD, RD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35458108 | Background | Cao S, Shaw EL, Quarles WR, Sasaki GY, Dey P, Hodges JK, Pokala A, Zeng M, Bruno RS. Daily Inclusion of Resistant Starch-Containing Potatoes in a Dietary Guidelines for Americans Dietary Pattern Does Not Adversely Affect Cardiometabolic Risk or Intestinal Permeability in Adults with Metabolic Syndrome: A Randomized Controlled Trial. Nutrients. 2022 Apr 8;14(8):1545. doi: 10.3390/nu14081545. |
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Data will be published as aggregate only. Data sharing may be possible pending institutional agreements.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bagel Diet First and Potato Diet | Participants were provided a prescribed eucaloric diet for 2-weeks that contained a bagel (comparator treatment). After a washout period of 2 weeks, they then received an identical diet for 2-weeks that contained potatoes instead of bagels (comparator arm). |
| FG001 | Potato Diet First and Bagel Diet | Participants were provided a prescribed eucaloric diet for 2-weeks that contained a potato. After a washout period of 2 weeks, they then received an identical diet for 2-weeks that contained bagels instead of a potatoes (comparator arm). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (2 Weeks) |
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| Washout (2 Weeks) |
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| Second Intervention (2 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Measures - All Participants | Baseline Measures of All Participants Prior To Randomization |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Endotoxin | Fasting serum endotoxin concentration | Posted | Mean | Standard Deviation | EU/mL | Day 14 |
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Participation in this cross-over study for each subject was approximately 8 weeks in duration.
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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 | Bagel Diet | Bagel consumed daily for 2 weeks Bagel: A bagel will be consumed daily for 2 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Bruno, Principal Investigator | The Ohio State University | 6142925522 | bruno.27@osu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2021 | Mar 4, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 9, 2018 | Mar 4, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D019446 | Endotoxemia |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D016470 | Bacteremia |
| D018805 | Sepsis |
| D007239 | Infections |
| D014115 | Toxemia |
| D018746 |
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| Potato |
| Other |
A potato will be consumed daily for 2 weeks. |
|
| Fasting Insulin Day 0 | Fasting plasma insulin | Fasting insulin on Day 0 |
| Fasting Insulin Day 14 | Fasting plasma insulin Day 14 | Fasting insulin on Day 14 |
| Postprandial Insulin | Plasma insulin concentration area under curve change from baseline | Day 14 postprandial (0, 30, 60, 90, 120 minutes) |
| Postprandial Glucose | Postprandial plasma glucose concentration area under curve change from baseline | Day 14 postprandial (0, 30, 60, 90, 120 minutes) |
| Fasting Endotoxin | Fasting serum endotoxin concentration | Day 0 |
| Postprandial Endotoxin | Postprandial serum endotoxin concentration area under curve change from baseline | Day 14 postprandial (0, 30, 60, 90, 120 minutes) |
| Lactulose/Mannitol Ratio | Urinary concentration of the non-digestible sugars lactulose/mannitol (mg/mg) | Day 14, 0-5 hours post-consumption of sugar probes |
| Sucralose/Erythritol Ratio | Urinary concentration of the non-digestible sugars sucralose/erythritol | Day 14, 6-24 hours post-consumption of sugar probes |
| Fecal Butyrate | Fecal concentration of butyrate | Day 14 |
| Fecal Acetate | Fecal concentration of acetate | Day 14 |
| Fecal Propionate | Fecal concentration of propionate | Day 14 |
| Postprandial Cholecystokinin | Plasma CCK area under curve change from baseline | Day 14 postprandial (0, 30, 60, 90, 120 minutes) |
| Fasting Cholecystokinin | Fasting plasma concentration of CCK | Day 14 |
| Postprandial NOx | Plasma total nitrite/nitrate area under curve change from baseline | Day 14 postprandial (0, 30, 60, 90, 120 minutes) |
| Fasting NOx | Fasting plasma concentration of nitrite/nitrate | Day 14 |
| Postprandial Malondialdehyde (MDA) | Plasma MDA concentration, biomarker of oxidative stress area under curve change from baseline | Day 14 postprandial (0, 30, 60, 90, 120 minutes) |
| Fasting Malondialdehyde (MDA) | Fasting plasma MDA concentration, biomarker of oxidative stress | 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 | Day 14 |
| Vitamin C | Fasting vitamin C concentration, biomarker of oxidative stress | Day 14 |
| cIMT | Carotid intima-media thickness. Mean thickness of left and right carotid artery intima media. | Day 14 |
| Day 14 BMI | Body mass index calculated as kg weight per meters squared | Day 14 |
| Day 0 Waist Circumference | Waist circumference in centimeters | Day 0 |
| Day 14 Waist Circumference | Waist circumference in centimeters | Day 14 |
| Day 0 Diastolic Blood Pressure | Diastolic blood pressure on Day 0 | Day 0 |
| Day 14 Diastolic Blood Pressure | Diastolic blood pressure on Day 14 | Day 14 |
| Day 0 Systolic Blood Pressure | Systolic blood pressure on Day 0 | Day 0 |
| Day 14 Systolic Blood Pressure | Systolic blood pressure on Day 14 | Day 14 |
| Day 0 BMI | Body mass index calculated as kg weight per meters squared | Day 0 |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Body mass index (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
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| Waist Circumference (cm) | Mean | Standard Deviation | cm |
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| Systolic Blood Pressure (mmHg) | Mean | Standard Deviation | mmHg |
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| Diastolic Blood Pressure (mmHg) | Mean | Standard Deviation | mmHg |
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| Plasma Glucose (mg/dl) | Mean | Standard Deviation | mg/dL |
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| Plasma High-density Lipoprotein-Cholesterol (mg/dl) | Mean | Standard Deviation | mg/dL |
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| Plasma Triglyceride (mg/dl) | Mean | Standard Deviation | mg/dL |
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| Plasma Ascorbic Acid (umol/L) | Mean | Standard Deviation | umol/L |
|
| Participants |
|
|
| Primary | 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) | Posted | Mean | Standard Error | % x min | Day 14 Postprandial (0, 30, 60, 90, 120 minutes) |
|
|
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| Secondary | Fasting Glucose Day 0 | Fasting plasma glucose | Posted | Mean | Standard Deviation | mg/dL | Fasting glucose on Day 0 |
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|
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| Secondary | Fasting Glucose Day 14 | Fasting plasma glucose Day 14 | Posted | Mean | Standard Deviation | mg/dL | Fasting glucose on Day 14 |
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| Secondary | Fasting Insulin Day 0 | Fasting plasma insulin | Posted | Mean | Standard Error | uIU/mL | Fasting insulin on Day 0 |
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| Secondary | Fasting Insulin Day 14 | Fasting plasma insulin Day 14 | Posted | Mean | Standard Error | uIU/mL | Fasting insulin on Day 14 |
|
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| Secondary | Postprandial Insulin | Plasma insulin concentration area under curve change from baseline | Posted | Mean | Standard Error | uIU/mL x min | Day 14 postprandial (0, 30, 60, 90, 120 minutes) |
|
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| Secondary | Postprandial Glucose | Postprandial plasma glucose concentration area under curve change from baseline | Posted | Mean | Standard Error | mg/dL x min | Day 14 postprandial (0, 30, 60, 90, 120 minutes) |
|
|
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| Secondary | Fasting Endotoxin | Fasting serum endotoxin concentration | Posted | Mean | Standard Error | EU/mL | Day 0 |
|
|
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| Secondary | Postprandial Endotoxin | Postprandial serum endotoxin concentration area under curve change from baseline | Posted | Mean | Standard Error | EU/ml x min | Day 14 postprandial (0, 30, 60, 90, 120 minutes) |
|
|
|
| Secondary | Lactulose/Mannitol Ratio | Urinary concentration of the non-digestible sugars lactulose/mannitol (mg/mg) | Posted | Mean | Standard Error | Ratio (mg/mg) | Day 14, 0-5 hours post-consumption of sugar probes |
|
|
|
| Secondary | Sucralose/Erythritol Ratio | Urinary concentration of the non-digestible sugars sucralose/erythritol | Posted | Mean | Standard Error | Ratio (mg/mg) | Day 14, 6-24 hours post-consumption of sugar probes |
|
|
|
| Secondary | Fecal Butyrate | Fecal concentration of butyrate | Posted | Mean | Standard Error | umol/g | Day 14 |
|
|
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| Secondary | Fecal Acetate | Fecal concentration of acetate | Posted | Mean | Standard Error | umol/g | Day 14 |
|
|
|
| Secondary | Fecal Propionate | Fecal concentration of propionate | Posted | Mean | Standard Error | umol/g | Day 14 |
|
|
|
| Secondary | Postprandial Cholecystokinin | Plasma CCK area under curve change from baseline | Posted | Mean | Standard Error | pmol/L x min | Day 14 postprandial (0, 30, 60, 90, 120 minutes) |
|
|
|
| Secondary | Fasting Cholecystokinin | Fasting plasma concentration of CCK | Posted | Mean | Standard Error | pmol/L | Day 14 |
|
|
|
| Secondary | Postprandial NOx | Plasma total nitrite/nitrate area under curve change from baseline | Posted | Mean | Standard Error | umol/L x min | Day 14 postprandial (0, 30, 60, 90, 120 minutes) |
|
|
|
| Secondary | Fasting NOx | Fasting plasma concentration of nitrite/nitrate | Posted | Mean | Standard Error | umol/L x min | Day 14 |
|
|
|
| Secondary | Postprandial Malondialdehyde (MDA) | Plasma MDA concentration, biomarker of oxidative stress area under curve change from baseline | Posted | Mean | Standard Error | umol/L x min | Day 14 postprandial (0, 30, 60, 90, 120 minutes) |
|
|
|
| Secondary | Fasting Malondialdehyde (MDA) | Fasting plasma MDA concentration, biomarker of oxidative stress | Posted | Mean | Standard Error | umol/L | Day 14 |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Error | % change in blood vessel dilation | Day 14 |
|
|
|
| Secondary | Vitamin C | Fasting vitamin C concentration, biomarker of oxidative stress | Posted | Mean | Standard Error | umol/L | Day 14 |
|
|
|
| Secondary | cIMT | Carotid intima-media thickness. Mean thickness of left and right carotid artery intima media. | Posted | Mean | Standard Deviation | mm | Day 14 |
|
|
|
| Secondary | Day 14 BMI | Body mass index calculated as kg weight per meters squared | Posted | Mean | Standard Error | kg/m^2 | Day 14 |
|
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| Secondary | Day 0 Waist Circumference | Waist circumference in centimeters | Posted | Mean | Standard Error | cm | Day 0 |
|
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| Secondary | Day 14 Waist Circumference | Waist circumference in centimeters | Posted | Mean | Standard Error | mmHg | Day 14 |
|
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| Secondary | Day 0 Diastolic Blood Pressure | Diastolic blood pressure on Day 0 | Posted | Mean | Standard Error | mmHg | Day 0 |
|
|
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| Secondary | Day 14 Diastolic Blood Pressure | Diastolic blood pressure on Day 14 | Posted | Mean | Standard Error | mmHg | Day 14 |
|
|
|
| Secondary | Day 0 Systolic Blood Pressure | Systolic blood pressure on Day 0 | Posted | Mean | Standard Error | mmHg | Day 0 |
|
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| Secondary | Day 14 Systolic Blood Pressure | Systolic blood pressure on Day 14 | Posted | Mean | Standard Error | mmHg | Day 14 |
|
|
|
| Secondary | Day 0 BMI | Body mass index calculated as kg weight per meters squared | Posted | Mean | Standard Error | kg/m^2 | Day 0 |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Potato Diet | Potato consumed daily for 2 weeks Potato: A potato will be consumed daily for 2 weeks. | 0 | 29 | 0 | 29 | 0 | 29 |
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| Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |