Cardiovascular DiseasesNCT03624569
Cardiometabolic Benefits of Potatoes Mediated Along the Gut-Vessel Axis in Adults With Metabolic Syndrome
A study testing Bagel and Potato in people with Cardiovascular Diseases and Endotoxemia, run by Ohio State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cardiovascular Diseases, Endotoxemia, Endothelial Dysfunction
- What is being tested?
- Bagel and Potato
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2018to 16 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Fasting glucose 100-125 mg/dL
- Waist circumference >102 cm (men), >88 cm (women)
- Fasting triglyceride >150 mg/dL
- Fasting HDL cholesterol <40 mg/dL (men), <50 mg/dL (women)
- Non-smoker
- Non-dietary supplement user (>1-mo)
- Free of gastrointestinal disorders, cardiovascular disease, cancer
- No recent use of antibiotics or any medications affecting glycemia, lipidemia, or blood pressure
Who cannot join
- Use of anti-inflammatory agents or probiotics
- Vegetarian, gluten-intolerant, carbohydrate-restricted diet
- Alcohol intake >2 drinks/d
- >7 hours/week of aerobic activity
- Women who are pregnant or lactating or have initiated or changed birth control in the past 3-months
- Taking medications that affect blood sugar, blood pressure, blood vessel health, or inflammation
Show all 11Show fewer
- High blood pressure or any vascular diseases
- HIV, hepatitis, or blood disorders such as hemophilia
- Gastrointestinal disorders
- Cancer (current or past history)
- Anemia
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Cardiovascular Diseases, Endotoxemia, Endothelial Dysfunction, Postprandial Hyperglycemia, Gut Health
- Being tested
- Bagel, Potato
- Medical subject headings
- Cardiovascular Diseases, Endotoxemia, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BagelOther
A bagel will be consumed daily for 2 weeks.
PotatoOther
A potato will be consumed daily for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bagel diet | Sham comparator | Bagel consumed daily for 2 weeks Receives: Other: Bagel |
| Potato diet | Experimental | Potato consumed daily for 2 weeks Receives: Other: Potato |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotoxin
Fasting serum endotoxin concentration
Measured: 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)
Measured: Day 14 Postprandial (0, 30, 60, 90, 120 minutes)
Secondary outcomes (30)
Fasting Glucose Day 0
Fasting plasma glucose
Measured: Fasting glucose on Day 0
Fasting Glucose Day 14
Fasting plasma glucose Day 14
Measured: Fasting glucose on Day 14
Fasting Insulin Day 0
Fasting plasma insulin
Measured: Fasting insulin on Day 0
Fasting Insulin Day 14
Fasting plasma insulin Day 14
Measured: Fasting insulin on Day 14
Postprandial Insulin
Plasma insulin concentration area under curve change from baseline
Measured: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Postprandial Glucose
Postprandial plasma glucose concentration area under curve change from baseline
Measured: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Fasting Endotoxin
Fasting serum endotoxin concentration
Measured: Day 0
Postprandial Endotoxin
Postprandial serum endotoxin concentration area under curve change from baseline
Measured: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Lactulose/Mannitol Ratio
Urinary concentration of the non-digestible sugars lactulose/mannitol (mg/mg)
Measured: Day 14, 0-5 hours post-consumption of sugar probes
Sucralose/Erythritol Ratio
Urinary concentration of the non-digestible sugars sucralose/erythritol
Measured: Day 14, 6-24 hours post-consumption of sugar probes
Fecal Butyrate
Fecal concentration of butyrate
Measured: Day 14
Fecal Acetate
Fecal concentration of acetate
Measured: Day 14
Fecal Propionate
Fecal concentration of propionate
Measured: Day 14
Postprandial Cholecystokinin
Plasma CCK area under curve change from baseline
Measured: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Fasting Cholecystokinin
Fasting plasma concentration of CCK
Measured: Day 14
Postprandial NOx
Plasma total nitrite/nitrate area under curve change from baseline
Measured: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Fasting NOx
Fasting plasma concentration of nitrite/nitrate
Measured: Day 14
Postprandial Malondialdehyde (MDA)
Plasma MDA concentration, biomarker of oxidative stress area under curve change from baseline
Measured: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Fasting Malondialdehyde (MDA)
Fasting plasma MDA concentration, biomarker of oxidative stress
Measured: 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
Measured: Day 14
Vitamin C
Fasting vitamin C concentration, biomarker of oxidative stress
Measured: Day 14
cIMT
Carotid intima-media thickness. Mean thickness of left and right carotid artery intima media.
Measured: Day 14
Day 14 BMI
Body mass index calculated as kg weight per meters squared
Measured: Day 14
Day 0 Waist Circumference
Waist circumference in centimeters
Measured: Day 0
Day 14 Waist Circumference
Waist circumference in centimeters
Measured: Day 14
Day 0 Diastolic Blood Pressure
Diastolic blood pressure on Day 0
Measured: Day 0
Day 14 Diastolic Blood Pressure
Diastolic blood pressure on Day 14
Measured: Day 14
Day 0 Systolic Blood Pressure
Systolic blood pressure on Day 0
Measured: Day 0
Day 14 Systolic Blood Pressure
Systolic blood pressure on Day 14
Measured: Day 14
Day 0 BMI
Body mass index calculated as kg weight per meters squared
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start15 Aug 2018
- Primary completion16 Jul 2020
- Study completion16 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Alliance for Potato Research and Education
- Responsible party
- Principal investigator, Richard Bruno, Ohio State University
- Investigators
- Richard Bruno, PhD, RD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624569
- Sponsor's protocol ID
- 2018H0265
- Status last verified
- Jun 2025
- First submitted
- 2 Aug 2018
- Last updated
- 15 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be published as aggregate only. Data sharing may be possible pending institutional agreements.
Publications
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.
PubMed 35458108
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Benefits of Potatoes Mediated Along the Gut-Vessel Axis in Adults With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03624569
- Acronym / sponsor ID
- 2018H0265
- Conditions
- Cardiovascular Diseases, Endotoxemia, Endothelial Dysfunction, Postprandial Hyperglycemia, Gut Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Alliance for Potato Research and Education
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 16 Jul 2020 (actual)
- Study completion
- 16 Jul 2020 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Posted 15 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bagel diet | Sham comparator | Other: BagelBagel consumed daily for 2 weeks |
| Potato diet | Experimental | Other: PotatoPotato consumed daily for 2 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Fasting glucose 100-125 mg/dL
- Waist circumference >102 cm (men), >88 cm (women)
- Fasting triglyceride >150 mg/dL
- Fasting HDL cholesterol <40 mg/dL (men), <50 mg/dL (women)
- Non-smoker
Key exclusion criteria (11 listed)
- Use of anti-inflammatory agents or probiotics
- Vegetarian, gluten-intolerant, carbohydrate-restricted diet
- Alcohol intake >2 drinks/d
- >7 hours/week of aerobic activity
- Women who are pregnant or lactating or have initiated or changed birth control in the past 3-months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BagelA bagel will be consumed daily for 2 weeks. | Other | Bagel diet |
| PotatoA potato will be consumed daily for 2 weeks. | Other | Potato diet |
Primary outcome
Endotoxin
Time frame: Day 14
Fasting serum endotoxin concentration
Vascular Endothelial Function
Time frame: Day 14 Postprandial (0, 30, 60, 90, 120 minutes)
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)
30 secondary outcomes
Fasting Glucose Day 0
Time frame: Fasting glucose on Day 0
Fasting Glucose Day 14
Time frame: Fasting glucose on Day 14
Fasting Insulin Day 0
Time frame: Fasting insulin on Day 0
Fasting Insulin Day 14
Time frame: Fasting insulin on Day 14
Postprandial Insulin
Time frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Postprandial Glucose
Time frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Fasting Endotoxin
Time frame: Day 0
Postprandial Endotoxin
Time frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Lactulose/Mannitol Ratio
Time frame: Day 14, 0-5 hours post-consumption of sugar probes
Sucralose/Erythritol Ratio
Time frame: Day 14, 6-24 hours post-consumption of sugar probes
Fecal Butyrate
Time frame: Day 14
Fecal Acetate
Time frame: Day 14
Fecal Propionate
Time frame: Day 14
Postprandial Cholecystokinin
Time frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Fasting Cholecystokinin
Time frame: Day 14
Postprandial NOx
Time frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Fasting NOx
Time frame: Day 14
Postprandial Malondialdehyde (MDA)
Time frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Fasting Malondialdehyde (MDA)
Time frame: Day 14
Fasting Vascular Endothelial Function
Time frame: Day 14
Vitamin C
Time frame: Day 14
cIMT
Time frame: Day 14
Day 14 BMI
Time frame: Day 14
Day 0 Waist Circumference
Time frame: Day 0
Day 14 Waist Circumference
Time frame: Day 14
Day 0 Diastolic Blood Pressure
Time frame: Day 0
Day 14 Diastolic Blood Pressure
Time frame: Day 14
Day 0 Systolic Blood Pressure
Time frame: Day 0
Day 14 Systolic Blood Pressure
Time frame: Day 14
Day 0 BMI
Time frame: Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35458108Cao 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.
- Individual participant dataSharing planned: Undecided. Data will be published as aggregate only. Data sharing may be possible pending institutional agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Bruno, PhD, RD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bagel and Potato in people with Cardiovascular Diseases and Endotoxemia, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endotoxin (time frame: Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03624569, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.