Cardiometabolic Benefits of Potatoes Mediated Along the Gut-Vessel Axis in Adults With Metabolic Syndrome

June 12, 2025 updated by: Richard Bruno, Ohio State University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • High blood pressure or any vascular diseases
  • HIV, hepatitis, or blood disorders such as hemophilia
  • Gastrointestinal disorders
  • Cancer (current or past history)
  • Anemia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Bagel diet
Bagel consumed daily for 2 weeks
Other: Bagel
A bagel will be consumed daily for 2 weeks.
Experimental: Potato diet
Potato consumed daily for 2 weeks
Other: Potato
A potato will be consumed daily for 2 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Endotoxin
Time Frame: Day 14
Fasting serum endotoxin concentration
Day 14
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)
Day 14 Postprandial (0, 30, 60, 90, 120 minutes)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fasting Glucose Day 0
Time Frame: Fasting glucose on Day 0
Fasting plasma glucose
Fasting glucose on Day 0
Fasting Insulin Day 0
Time Frame: Fasting insulin on Day 0
Fasting plasma insulin
Fasting insulin on Day 0
Postprandial Insulin
Time Frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Plasma insulin concentration area under curve change from baseline
Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Postprandial Glucose
Time Frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Postprandial plasma glucose concentration area under curve change from baseline
Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Fasting Endotoxin
Time Frame: Day 0
Fasting serum endotoxin concentration
Day 0
Postprandial Endotoxin
Time Frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Postprandial serum endotoxin concentration area under curve change from baseline
Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Postprandial Cholecystokinin
Time Frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Plasma CCK area under curve change from baseline
Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Postprandial NOx
Time Frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Plasma total nitrite/nitrate area under curve change from baseline
Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Fasting NOx
Time Frame: Day 14
Fasting plasma concentration of nitrite/nitrate
Day 14
Postprandial Malondialdehyde (MDA)
Time Frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
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)
Time Frame: Day 14
Fasting plasma MDA concentration, biomarker of oxidative stress
Day 14
Vitamin C
Time Frame: Day 14
Fasting vitamin C concentration, biomarker of oxidative stress
Day 14
Fasting Glucose Day 14
Time Frame: Fasting glucose on Day 14
Fasting plasma glucose Day 14
Fasting glucose on Day 14
Fasting Insulin Day 14
Time Frame: Fasting insulin on Day 14
Fasting plasma insulin Day 14
Fasting insulin on Day 14
Lactulose/Mannitol Ratio
Time Frame: Day 14, 0-5 hours post-consumption of sugar probes
Urinary concentration of the non-digestible sugars lactulose/mannitol (mg/mg)
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
Urinary concentration of the non-digestible sugars sucralose/erythritol
Day 14, 6-24 hours post-consumption of sugar probes
Fecal Butyrate
Time Frame: Day 14
Fecal concentration of butyrate
Day 14
Fecal Acetate
Time Frame: Day 14
Fecal concentration of acetate
Day 14
Fecal Propionate
Time Frame: Day 14
Fecal concentration of propionate
Day 14
Fasting Cholecystokinin
Time Frame: Day 14
Fasting plasma concentration of CCK
Day 14
Fasting Vascular Endothelial Function
Time Frame: Day 14
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
cIMT
Time Frame: Day 14
Carotid intima-media thickness. Mean thickness of left and right carotid artery intima media.
Day 14
Day 14 BMI
Time Frame: Day 14
Body mass index calculated as kg weight per meters squared
Day 14
Day 0 Waist Circumference
Time Frame: Day 0
Waist circumference in centimeters
Day 0
Day 14 Waist Circumference
Time Frame: Day 14
Waist circumference in centimeters
Day 14
Day 0 Diastolic Blood Pressure
Time Frame: Day 0
Diastolic blood pressure on Day 0
Day 0
Day 14 Diastolic Blood Pressure
Time Frame: Day 14
Diastolic blood pressure on Day 14
Day 14
Day 0 Systolic Blood Pressure
Time Frame: Day 0
Systolic blood pressure on Day 0
Day 0
Day 14 Systolic Blood Pressure
Time Frame: Day 14
Systolic blood pressure on Day 14
Day 14
Day 0 BMI
Time Frame: Day 0
Body mass index calculated as kg weight per meters squared
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alliance for Potato Research and Education

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard Bruno, PhD, RD, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 16, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 16, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 10, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018H0265

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will be published as aggregate only. Data sharing may be possible pending institutional agreements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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