Ohio State University
Columbus, Ohio, 43210, United States
NCT Number: NCT03624569
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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Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Columbus, Ohio, 43210, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A bagel will be consumed daily for 2 weeks.
A potato will be consumed daily for 2 weeks.
Time frame: Day 14
Fasting serum endotoxin concentration
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)
Time frame: Fasting glucose on Day 0
Fasting plasma glucose
Time frame: Fasting glucose on Day 14
Fasting plasma glucose Day 14
Time frame: Fasting insulin on Day 0
Fasting plasma insulin
Time frame: Fasting insulin on Day 14
Fasting plasma insulin Day 14
Time frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Plasma insulin concentration area under curve change from baseline
Time frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Postprandial plasma glucose concentration area under curve change from baseline
Time frame: Day 0
Fasting serum endotoxin concentration
Time frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Postprandial serum endotoxin concentration area under curve change from baseline
Time frame: Day 14, 0-5 hours post-consumption of sugar probes
Urinary concentration of the non-digestible sugars lactulose/mannitol (mg/mg)
Time frame: Day 14, 6-24 hours post-consumption of sugar probes
Urinary concentration of the non-digestible sugars sucralose/erythritol
Time frame: Day 14
Fecal concentration of butyrate
Time frame: Day 14
Fecal concentration of acetate
Time frame: Day 14
Fecal concentration of propionate
Time frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Plasma CCK area under curve change from baseline
Time frame: Day 14
Fasting plasma concentration of CCK
Time frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Plasma total nitrite/nitrate area under curve change from baseline
Time frame: Day 14
Fasting plasma concentration of nitrite/nitrate
Time frame: Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Plasma MDA concentration, biomarker of oxidative stress area under curve change from baseline
Time frame: Day 14
Fasting plasma MDA concentration, biomarker of oxidative stress
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
Time frame: Day 14
Fasting vitamin C concentration, biomarker of oxidative stress
Time frame: Day 14
Carotid intima-media thickness. Mean thickness of left and right carotid artery intima media.
Time frame: Day 14
Body mass index calculated as kg weight per meters squared
Time frame: Day 0
Waist circumference in centimeters
Time frame: Day 14
Waist circumference in centimeters
Time frame: Day 0
Diastolic blood pressure on Day 0
Time frame: Day 14
Diastolic blood pressure on Day 14
Time frame: Day 0
Systolic blood pressure on Day 0
Time frame: Day 14
Systolic blood pressure on Day 14
Time frame: Day 0
Body mass index calculated as kg weight per meters squared
Ohio State University
Other
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