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Completed

NCT Number: NCT03624569

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bagel

Other

A bagel will be consumed daily for 2 weeks.

Potato

Other

A potato will be consumed daily for 2 weeks.

Primary outcomes

  1. Endotoxin

    Time frame: Day 14

    Fasting serum endotoxin concentration

  2. 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)

Secondary outcomes

  1. Fasting Glucose Day 0

    Time frame: Fasting glucose on Day 0

    Fasting plasma glucose

  2. Fasting Glucose Day 14

    Time frame: Fasting glucose on Day 14

    Fasting plasma glucose Day 14

  3. Fasting Insulin Day 0

    Time frame: Fasting insulin on Day 0

    Fasting plasma insulin

  4. Fasting Insulin Day 14

    Time frame: Fasting insulin on Day 14

    Fasting plasma insulin Day 14

  5. Postprandial Insulin

    Time frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)

    Plasma insulin concentration area under curve change from baseline

  6. Postprandial Glucose

    Time frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)

    Postprandial plasma glucose concentration area under curve change from baseline

  7. Fasting Endotoxin

    Time frame: Day 0

    Fasting serum endotoxin concentration

  8. Postprandial Endotoxin

    Time frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)

    Postprandial serum endotoxin concentration area under curve change from baseline

  9. 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)

  10. Sucralose/Erythritol Ratio

    Time frame: Day 14, 6-24 hours post-consumption of sugar probes

    Urinary concentration of the non-digestible sugars sucralose/erythritol

  11. Fecal Butyrate

    Time frame: Day 14

    Fecal concentration of butyrate

  12. Fecal Acetate

    Time frame: Day 14

    Fecal concentration of acetate

  13. Fecal Propionate

    Time frame: Day 14

    Fecal concentration of propionate

  14. Postprandial Cholecystokinin

    Time frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)

    Plasma CCK area under curve change from baseline

  15. Fasting Cholecystokinin

    Time frame: Day 14

    Fasting plasma concentration of CCK

  16. Postprandial NOx

    Time frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)

    Plasma total nitrite/nitrate area under curve change from baseline

  17. Fasting NOx

    Time frame: Day 14

    Fasting plasma concentration of nitrite/nitrate

  18. 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

  19. Fasting Malondialdehyde (MDA)

    Time frame: Day 14

    Fasting plasma MDA concentration, biomarker of oxidative stress

  20. 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

  21. Vitamin C

    Time frame: Day 14

    Fasting vitamin C concentration, biomarker of oxidative stress

  22. cIMT

    Time frame: Day 14

    Carotid intima-media thickness. Mean thickness of left and right carotid artery intima media.

  23. Day 14 BMI

    Time frame: Day 14

    Body mass index calculated as kg weight per meters squared

  24. Day 0 Waist Circumference

    Time frame: Day 0

    Waist circumference in centimeters

  25. Day 14 Waist Circumference

    Time frame: Day 14

    Waist circumference in centimeters

  26. Day 0 Diastolic Blood Pressure

    Time frame: Day 0

    Diastolic blood pressure on Day 0

  27. Day 14 Diastolic Blood Pressure

    Time frame: Day 14

    Diastolic blood pressure on Day 14

  28. Day 0 Systolic Blood Pressure

    Time frame: Day 0

    Systolic blood pressure on Day 0

  29. Day 14 Systolic Blood Pressure

    Time frame: Day 14

    Systolic blood pressure on Day 14

  30. Day 0 BMI

    Time frame: Day 0

    Body mass index calculated as kg weight per meters squared

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Alliance for Potato Research and Education

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 10, 2018
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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