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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03624569
Enrollment
32
Registered
2018-08-10
Start date
2018-08-15
Completion date
2020-07-16
Last updated
2025-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Endotoxemia, Endothelial Dysfunction, Postprandial Hyperglycemia, Gut Health

Brief 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. 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.

Interventions

OTHERBagel

A bagel will be consumed daily for 2 weeks.

OTHERPotato

A potato will be consumed daily for 2 weeks.

Sponsors

Alliance for Potato Research and Education
CollaboratorOTHER
Ohio State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
EndotoxinDay 14Fasting serum endotoxin concentration
Vascular Endothelial FunctionDay 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

MeasureTime frameDescription
Fasting Glucose Day 0Fasting glucose on Day 0Fasting plasma glucose
Fasting Glucose Day 14Fasting glucose on Day 14Fasting plasma glucose Day 14
Fasting Insulin Day 0Fasting insulin on Day 0Fasting plasma insulin
Fasting Insulin Day 14Fasting insulin on Day 14Fasting plasma insulin Day 14
Postprandial InsulinDay 14 postprandial (0, 30, 60, 90, 120 minutes)Plasma insulin concentration area under curve change from baseline
Postprandial GlucoseDay 14 postprandial (0, 30, 60, 90, 120 minutes)Postprandial plasma glucose concentration area under curve change from baseline
Fasting EndotoxinDay 0Fasting serum endotoxin concentration
Postprandial EndotoxinDay 14 postprandial (0, 30, 60, 90, 120 minutes)Postprandial serum endotoxin concentration area under curve change from baseline
Lactulose/Mannitol RatioDay 14, 0-5 hours post-consumption of sugar probesUrinary concentration of the non-digestible sugars lactulose/mannitol (mg/mg)
Sucralose/Erythritol RatioDay 14, 6-24 hours post-consumption of sugar probesUrinary concentration of the non-digestible sugars sucralose/erythritol
Fecal ButyrateDay 14Fecal concentration of butyrate
Fecal AcetateDay 14Fecal concentration of acetate
Fecal PropionateDay 14Fecal concentration of propionate
Postprandial CholecystokininDay 14 postprandial (0, 30, 60, 90, 120 minutes)Plasma CCK area under curve change from baseline
Fasting CholecystokininDay 14Fasting plasma concentration of CCK
Postprandial NOxDay 14 postprandial (0, 30, 60, 90, 120 minutes)Plasma total nitrite/nitrate area under curve change from baseline
Fasting NOxDay 14Fasting plasma concentration of nitrite/nitrate
Postprandial Malondialdehyde (MDA)Day 14 postprandial (0, 30, 60, 90, 120 minutes)Plasma MDA concentration, biomarker of oxidative stress area under curve change from baseline
Fasting Malondialdehyde (MDA)Day 14Fasting plasma MDA concentration, biomarker of oxidative stress
Fasting Vascular Endothelial FunctionDay 14Fasting 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
Vitamin CDay 14Fasting vitamin C concentration, biomarker of oxidative stress
cIMTDay 14Carotid intima-media thickness. Mean thickness of left and right carotid artery intima media.
Day 14 BMIDay 14Body mass index calculated as kg weight per meters squared
Day 0 Waist CircumferenceDay 0Waist circumference in centimeters
Day 14 Waist CircumferenceDay 14Waist circumference in centimeters
Day 0 Diastolic Blood PressureDay 0Diastolic blood pressure on Day 0
Day 14 Diastolic Blood PressureDay 14Diastolic blood pressure on Day 14
Day 0 Systolic Blood PressureDay 0Systolic blood pressure on Day 0
Day 14 Systolic Blood PressureDay 14Systolic blood pressure on Day 14
Day 0 BMIDay 0Body mass index calculated as kg weight per meters squared

Countries

United States

Participant flow

Participants by arm

ArmCount
Baseline Measures - All Participants
Baseline Measures of All Participants Prior To Randomization
27
Total27

Withdrawals & dropouts

PeriodReasonFG000FG001
First Intervention (2 Weeks)Withdrawal by Subject12
Second Intervention (2 Weeks)Protocol Violation11

Baseline characteristics

CharacteristicBaseline Measures - All Participants
Age, Continuous32.5 years
STANDARD_DEVIATION 6.8
Body mass index (kg/m^2)35 kg/m^2
STANDARD_DEVIATION 5.1
Diastolic Blood Pressure (mmHg)82.9 mmHg
STANDARD_DEVIATION 5.6
Plasma Ascorbic Acid (umol/L)40.4 umol/L
STANDARD_DEVIATION 21.2
Plasma Glucose (mg/dl)103.7 mg/dL
STANDARD_DEVIATION 8.1
Plasma High-density Lipoprotein-Cholesterol (mg/dl)36.7 mg/dL
STANDARD_DEVIATION 7.4
Plasma Triglyceride (mg/dl)127.6 mg/dL
STANDARD_DEVIATION 80.4
Race and Ethnicity Not Collected— Participants
Region of Enrollment
United States
27 participants
Sex: Female, Male
Female
14 Participants
Sex: Female, Male
Male
13 Participants
Systolic Blood Pressure (mmHg)120.5 mmHg
STANDARD_DEVIATION 8.4
Waist Circumference (cm)109.8 cm
STANDARD_DEVIATION 12.2

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 290 / 29
other
Total, other adverse events
0 / 290 / 29
serious
Total, serious adverse events
0 / 290 / 29

Outcome results

Primary

Endotoxin

Fasting serum endotoxin concentration

Time frame: Day 14

ArmMeasureValue (MEAN)Dispersion
Bagel DietEndotoxin21.2 EU/mLStandard Deviation 3
Potato DietEndotoxin23.3 EU/mLStandard Deviation 3
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)

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

ArmMeasureValue (MEAN)Dispersion
Bagel DietVascular Endothelial Function-259 % x minStandard Error 75
Potato DietVascular Endothelial Function-198 % x minStandard Error 71
Secondary

cIMT

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

Time frame: Day 14

ArmMeasureValue (MEAN)Dispersion
Bagel DietcIMT0.603 mmStandard Deviation 0.109
Potato DietcIMT0.609 mmStandard Deviation 0.114
Secondary

Day 0 BMI

Body mass index calculated as kg weight per meters squared

Time frame: Day 0

ArmMeasureValue (MEAN)Dispersion
Bagel DietDay 0 BMI35.6 kg/m^2Standard Error 1.2
Potato DietDay 0 BMI35.7 kg/m^2Standard Error 1.2
Secondary

Day 0 Diastolic Blood Pressure

Diastolic blood pressure on Day 0

Time frame: Day 0

ArmMeasureValue (MEAN)Dispersion
Bagel DietDay 0 Diastolic Blood Pressure81.5 mmHgStandard Error 1.3
Potato DietDay 0 Diastolic Blood Pressure81.9 mmHgStandard Error 1.5
Secondary

Day 0 Systolic Blood Pressure

Systolic blood pressure on Day 0

Time frame: Day 0

ArmMeasureValue (MEAN)Dispersion
Bagel DietDay 0 Systolic Blood Pressure123.1 mmHgStandard Error 1.9
Potato DietDay 0 Systolic Blood Pressure119.1 mmHgStandard Error 2.2
Secondary

Day 0 Waist Circumference

Waist circumference in centimeters

Time frame: Day 0

ArmMeasureValue (MEAN)Dispersion
Bagel DietDay 0 Waist Circumference108.5 cmStandard Error 2.2
Potato DietDay 0 Waist Circumference119.1 cmStandard Error 2.2
Secondary

Day 14 BMI

Body mass index calculated as kg weight per meters squared

Time frame: Day 14

ArmMeasureValue (MEAN)Dispersion
Bagel DietDay 14 BMI35.1 kg/m^2Standard Error 1.1
Potato DietDay 14 BMI35.2 kg/m^2Standard Error 1.1
Secondary

Day 14 Diastolic Blood Pressure

Diastolic blood pressure on Day 14

Time frame: Day 14

ArmMeasureValue (MEAN)Dispersion
Bagel DietDay 14 Diastolic Blood Pressure75.9 mmHgStandard Error 1.7
Potato DietDay 14 Diastolic Blood Pressure77.7 mmHgStandard Error 1.4
Secondary

Day 14 Systolic Blood Pressure

Systolic blood pressure on Day 14

Time frame: Day 14

ArmMeasureValue (MEAN)Dispersion
Bagel DietDay 14 Systolic Blood Pressure113.6 mmHgStandard Error 1.9
Potato DietDay 14 Systolic Blood Pressure114.6 mmHgStandard Error 1.8
Secondary

Day 14 Waist Circumference

Waist circumference in centimeters

Time frame: Day 14

ArmMeasureValue (MEAN)Dispersion
Bagel DietDay 14 Waist Circumference107.8 mmHgStandard Error 2.4
Potato DietDay 14 Waist Circumference107.5 mmHgStandard Error 2.4
Secondary

Fasting Cholecystokinin

Fasting plasma concentration of CCK

Time frame: Day 14

ArmMeasureValue (MEAN)Dispersion
Bagel DietFasting Cholecystokinin14.3 pmol/LStandard Error 3.1
Potato DietFasting Cholecystokinin14.2 pmol/LStandard Error 3.4
Secondary

Fasting Endotoxin

Fasting serum endotoxin concentration

Time frame: Day 0

ArmMeasureValue (MEAN)Dispersion
Bagel DietFasting Endotoxin26.6 EU/mLStandard Error 2
Potato DietFasting Endotoxin22.3 EU/mLStandard Error 2.1
Secondary

Fasting Glucose Day 0

Fasting plasma glucose

Time frame: Fasting glucose on Day 0

ArmMeasureValue (MEAN)Dispersion
Bagel DietFasting Glucose Day 0104 mg/dLStandard Deviation 13.5
Potato DietFasting Glucose Day 0109.5 mg/dLStandard Deviation 14.6
Secondary

Fasting Glucose Day 14

Fasting plasma glucose Day 14

Time frame: Fasting glucose on Day 14

ArmMeasureValue (MEAN)Dispersion
Bagel DietFasting Glucose Day 14101.9 mg/dLStandard Deviation 12.3
Potato DietFasting Glucose Day 14102.3 mg/dLStandard Deviation 13.5
Secondary

Fasting Insulin Day 0

Fasting plasma insulin

Time frame: Fasting insulin on Day 0

ArmMeasureValue (MEAN)Dispersion
Bagel DietFasting Insulin Day 021.1 uIU/mLStandard Error 5.5
Potato DietFasting Insulin Day 017.0 uIU/mLStandard Error 2
Secondary

Fasting Insulin Day 14

Fasting plasma insulin Day 14

Time frame: Fasting insulin on Day 14

ArmMeasureValue (MEAN)Dispersion
Bagel DietFasting Insulin Day 1414.2 uIU/mLStandard Error 2
Potato DietFasting Insulin Day 1414.9 uIU/mLStandard Error 2.4
Secondary

Fasting Malondialdehyde (MDA)

Fasting plasma MDA concentration, biomarker of oxidative stress

Time frame: Day 14

ArmMeasureValue (MEAN)Dispersion
Bagel DietFasting Malondialdehyde (MDA)1.78 umol/LStandard Error 0.1
Potato DietFasting Malondialdehyde (MDA)1.93 umol/LStandard Error 0.1
Secondary

Fasting NOx

Fasting plasma concentration of nitrite/nitrate

Time frame: Day 14

ArmMeasureValue (MEAN)Dispersion
Bagel DietFasting NOx29.8 umol/L x minStandard Error 3.7
Potato DietFasting NOx30.1 umol/L x minStandard Error 2.3
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

Time frame: Day 14

ArmMeasureValue (MEAN)Dispersion
Bagel DietFasting Vascular Endothelial Function7.2 % change in blood vessel dilationStandard Error 1.3
Potato DietFasting Vascular Endothelial Function8.7 % change in blood vessel dilationStandard Error 1.3
Secondary

Fecal Acetate

Fecal concentration of acetate

Time frame: Day 14

ArmMeasureValue (MEAN)Dispersion
Bagel DietFecal Acetate52.3 umol/gStandard Error 4.7
Potato DietFecal Acetate46.6 umol/gStandard Error 3.9
Secondary

Fecal Butyrate

Fecal concentration of butyrate

Time frame: Day 14

ArmMeasureValue (MEAN)Dispersion
Bagel DietFecal Butyrate21.3 umol/gStandard Error 2.7
Potato DietFecal Butyrate17.9 umol/gStandard Error 2.6
Secondary

Fecal Propionate

Fecal concentration of propionate

Time frame: Day 14

ArmMeasureValue (MEAN)Dispersion
Bagel DietFecal Propionate23.1 umol/gStandard Error 2.2
Potato DietFecal Propionate19.3 umol/gStandard Error 2.1
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Bagel DietLactulose/Mannitol Ratio.154 Ratio (mg/mg)Standard Error 0.013
Potato DietLactulose/Mannitol Ratio.151 Ratio (mg/mg)Standard Error 0.1
Secondary

Postprandial Cholecystokinin

Plasma CCK area under curve change from baseline

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

ArmMeasureValue (MEAN)Dispersion
Bagel DietPostprandial Cholecystokinin-196 pmol/L x minStandard Error 266
Potato DietPostprandial Cholecystokinin-67 pmol/L x minStandard Error 344
Secondary

Postprandial Endotoxin

Postprandial serum endotoxin concentration area under curve change from baseline

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

ArmMeasureValue (MEAN)Dispersion
Bagel DietPostprandial Endotoxin450 EU/ml x minStandard Error 249
Potato DietPostprandial Endotoxin-120 EU/ml x minStandard Error 176
Secondary

Postprandial Glucose

Postprandial plasma glucose concentration area under curve change from baseline

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

ArmMeasureValue (MEAN)Dispersion
Bagel DietPostprandial Glucose2649 mg/dL x minStandard Error 499
Potato DietPostprandial Glucose2808 mg/dL x minStandard Error 565
Secondary

Postprandial Insulin

Plasma insulin concentration area under curve change from baseline

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

ArmMeasureValue (MEAN)Dispersion
Bagel DietPostprandial Insulin5940 uIU/mL x minStandard Error 670
Potato DietPostprandial Insulin7086 uIU/mL x minStandard Error 1372
Secondary

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)

ArmMeasureValue (MEAN)Dispersion
Bagel DietPostprandial Malondialdehyde (MDA)57.2 umol/L x minStandard Error 6.8
Potato DietPostprandial Malondialdehyde (MDA)45.4 umol/L x minStandard Error 7.2
Secondary

Postprandial NOx

Plasma total nitrite/nitrate area under curve change from baseline

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

ArmMeasureValue (MEAN)Dispersion
Bagel DietPostprandial NOx-240 umol/L x minStandard Error 88
Potato DietPostprandial NOx-433 umol/L x minStandard Error 48
Secondary

Sucralose/Erythritol Ratio

Urinary concentration of the non-digestible sugars sucralose/erythritol

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

ArmMeasureValue (MEAN)Dispersion
Bagel DietSucralose/Erythritol Ratio.0148 Ratio (mg/mg)Standard Error 0.002
Potato DietSucralose/Erythritol Ratio0.01667 Ratio (mg/mg)Standard Error 0.001925
Secondary

Vitamin C

Fasting vitamin C concentration, biomarker of oxidative stress

Time frame: Day 14

ArmMeasureValue (MEAN)Dispersion
Bagel DietVitamin C47.5 umol/LStandard Error 2.9
Potato DietVitamin C52.5 umol/LStandard Error 4.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026