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

Not Applicable

• Conditions: Cardiovascular Diseases; Endotoxemia; Endothelial Dysfunction; Postprandial Hyperglycemia; Gut Health
• Interventions: Other: Potato; Other: Bagel

• Registration Number: NCT03624569
• Lead Sponsor: Ohio State University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-08-02
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-10
• Study Start: 2018-08-15
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-15
• Last Update Posted: 2020-01-18
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Potato diet	Potato	Potato consumed daily for 2 weeks
Bagel diet	Bagel	Bagel consumed daily for 2 weeks

Primary Outcome Measures

Name	Time	Method
Endotoxin	Day 14	Fasting serum endotoxin concentration
Vascular endothelial function	Day 14 Postprandial (0, 30, 60, 90, 120 minutes)	Area under curve (change from baseline) for flow-mediated dilation of brachial artery

Secondary Outcome Measures

Name	Time	Method
Day 7 systolic blood pressure	Day 7	Systolic blood pressure
Day 14 systolic blood pressure	Day 14	Systolic blood pressure
Fecal acetate	Day 14	Fecal concentration of acetate
Day 0 weight	Day 0	Weight in kilograms
Fasting Malondialdehyde (MDA)	Day 14	Fasting plasma MDA concentration, biomarker of oxidative stress
Vitamin C	Day 14	Fasting vitamin C concentration, biomarker of oxidative stress
Lactulose/mannitol ratio	Day 14, 0-5 hours post-consumption of sugar probes	Urinary concentration of the non-digestible sugars lactulose/mannitol
Sucralose/erythritol ratio	Day 14, 6-24 hours post-consumption of sugar probes	Urinary concentration of the non-digestible sugars sucralose/erythritol
Fecal butyrate	Day 14	Fecal concentration of butyrate
Postprandial Gastric inhibitory peptide	Day 14 postprandial (0, 30, 60, 90, 120 minutes)	Plasma GIP area under curve change from baseline
Fasting cholecystokinin	Day 14	Fasting plasma concentration of CCK
Fasting NOx	Day 14	Fasting 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 Vascular Endothelial Function	Day 14	Fasting flow-mediated dilation of the brachial artery
Day 7 height	Day 7	Height in centimeters
Day 14 height	Day 14	Height in centimeters
Day 0 diastolic blood pressure	Day 0	Diastolic blood pressure
Postprandial Insulin	Day 14 postprandial (0, 30, 60, 90, 120 minutes)	Plasma insulin concentration area under curve change from baseline
Postprandial Endotoxin	Day 14 postprandial (0, 30, 60, 90, 120 minutes)	Postprandial serum endotoxin concentration area under curve change from baseline
Postprandial Cholecystokinin	Day 14 postprandial (0, 30, 60, 90, 120 minutes)	Plasma CCK area under curve change from baseline
Postprandial NOx	Day 14 postprandial (0, 30, 60, 90, 120 minutes)	Plasma total nitrite/nitrate area under curve change from baseline
Fasting Glucose Day 0	Fasting glucose on Day 0	Fasting plasma glucose
Postprandial Glucose	Day 14 postprandial (0, 30, 60, 90, 120 minutes)	Postprandial plasma glucose concentration area under curve change from baseline
Fasting Endotoxin	Day 0	Fasting serum endotoxin concentration
Postprandial glucagon-like peptide-1	Day 14 postprandial (0, 30, 60, 90, 120 minutes)	Plasma GLP-1 area under curve change from baseline
Fasting Gastric inhibitory peptide	Day 14	Fasting plasma concentration of GIP
Day 7 weight	Day 7	Weight in kilograms
Day 14 weight	Day 14	Weight in kilograms
Day 0 height	Day 0	Height in centimeters
Day 7 diastolic blood pressure	Day 7	Diastolic blood pressure
cIMT	Day 14	Carotid intima-media thickness
Day 7 waist circumference	Day 7	Waist circumference in centimeters
Fasting Glucose Day 14	Fasting glucose on Day 14	Fasting plasma glucose
Fasting Insulin Day 0	Fasting insulin on Day 0	Fasting plasma insulin
Fasting Insulin Day 14	Fasting insulin on Day 14	Fasting plasma insulin
Fecal propionate	Day 14	Fecal concentration of propionate
Fasting GLP-1	Day 14	Fasting plasma concentration of GLP-1
Day 0 waist circumference	Day 0	Waist circumference in centimeters
Day 14 waist circumference	Day 14	Waist circumference in centimeters
Day 14 diastolic blood pressure	Day 14	Diastolic blood pressure
Day 0 systolic blood pressure	Day 0	Systolic blood pressure

Trial Locations

Locations (1)

Ohio State University; 🇺🇸 Columbus, Ohio, United States