Cardiometabolic Benefits of Potatoes Mediated Along the Gut-Vessel Axis in Adults With Metabolic Syndrome
Primary Purpose
Cardiovascular Diseases, Endotoxemia, Endothelial Dysfunction
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bagel
Potato
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases
Eligibility Criteria
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
Sites / Locations
- Ohio State UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Bagel diet
Potato diet
Arm Description
Bagel consumed daily for 2 weeks
Potato consumed daily for 2 weeks
Outcomes
Primary Outcome Measures
Endotoxin
Fasting serum endotoxin concentration
Vascular endothelial function
Area under curve (change from baseline) for flow-mediated dilation of brachial artery
Secondary Outcome Measures
Fasting Glucose Day 0
Fasting plasma glucose
Fasting Glucose Day 14
Fasting plasma glucose
Fasting Insulin Day 0
Fasting plasma insulin
Fasting Insulin Day 14
Fasting plasma insulin
Postprandial Insulin
Plasma insulin concentration area under curve change from baseline
Postprandial Glucose
Postprandial plasma glucose concentration area under curve change from baseline
Fasting Endotoxin
Fasting serum endotoxin concentration
Postprandial Endotoxin
Postprandial serum endotoxin concentration area under curve change from baseline
Lactulose/mannitol ratio
Urinary concentration of the non-digestible sugars lactulose/mannitol
Sucralose/erythritol ratio
Urinary concentration of the non-digestible sugars sucralose/erythritol
Fecal butyrate
Fecal concentration of butyrate
Fecal acetate
Fecal concentration of acetate
Fecal propionate
Fecal concentration of propionate
Postprandial Cholecystokinin
Plasma CCK area under curve change from baseline
Postprandial glucagon-like peptide-1
Plasma GLP-1 area under curve change from baseline
Postprandial Gastric inhibitory peptide
Plasma GIP area under curve change from baseline
Fasting cholecystokinin
Fasting plasma concentration of CCK
Fasting GLP-1
Fasting plasma concentration of GLP-1
Fasting Gastric inhibitory peptide
Fasting plasma concentration of GIP
Postprandial NOx
Plasma total nitrite/nitrate area under curve change from baseline
Fasting NOx
Fasting plasma concentration of nitrite/nitrate
Postprandial Malondialdehyde (MDA)
Plasma MDA concentration, biomarker of oxidative stress area under curve change from baseline
Fasting Malondialdehyde (MDA)
Fasting plasma MDA concentration, biomarker of oxidative stress
Fasting Vascular Endothelial Function
Fasting flow-mediated dilation of the brachial artery
Vitamin C
Fasting vitamin C concentration, biomarker of oxidative stress
cIMT
Carotid intima-media thickness
Day 0 weight
Weight in kilograms
Day 7 weight
Weight in kilograms
Day 14 weight
Weight in kilograms
Day 0 height
Height in centimeters
Day 7 height
Height in centimeters
Day 14 height
Height in centimeters
Day 0 waist circumference
Waist circumference in centimeters
Day 7 waist circumference
Waist circumference in centimeters
Day 14 waist circumference
Waist circumference in centimeters
Day 0 diastolic blood pressure
Diastolic blood pressure
Day 7 diastolic blood pressure
Diastolic blood pressure
Day 14 diastolic blood pressure
Diastolic blood pressure
Day 0 systolic blood pressure
Systolic blood pressure
Day 7 systolic blood pressure
Systolic blood pressure
Day 14 systolic blood pressure
Systolic blood pressure
Full Information
NCT ID
NCT03624569
First Posted
August 2, 2018
Last Updated
January 15, 2020
Sponsor
Ohio State University
Collaborators
Alliance for Potato Research and Education
1. Study Identification
Unique Protocol Identification Number
NCT03624569
Brief Title
Cardiometabolic Benefits of Potatoes Mediated Along the Gut-Vessel Axis in Adults With Metabolic Syndrome
Official Title
Cardiometabolic Benefits of Potatoes Mediated Along the Gut-Vessel Axis in Adults With Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
Alliance for Potato Research and Education
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Endotoxemia, Endothelial Dysfunction, Postprandial Hyperglycemia, Gut Health
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bagel diet
Arm Type
Sham Comparator
Arm Description
Bagel consumed daily for 2 weeks
Arm Title
Potato diet
Arm Type
Experimental
Arm Description
Potato consumed daily for 2 weeks
Intervention Type
Other
Intervention Name(s)
Bagel
Intervention Description
A bagel will be consumed daily for 2 weeks.
Intervention Type
Other
Intervention Name(s)
Potato
Intervention Description
A potato will be consumed daily for 2 weeks.
Primary Outcome Measure Information:
Title
Endotoxin
Description
Fasting serum endotoxin concentration
Time Frame
Day 14
Title
Vascular endothelial function
Description
Area under curve (change from baseline) for flow-mediated dilation of brachial artery
Time Frame
Day 14 Postprandial (0, 30, 60, 90, 120 minutes)
Secondary Outcome Measure Information:
Title
Fasting Glucose Day 0
Description
Fasting plasma glucose
Time Frame
Fasting glucose on Day 0
Title
Fasting Glucose Day 14
Description
Fasting plasma glucose
Time Frame
Fasting glucose on Day 14
Title
Fasting Insulin Day 0
Description
Fasting plasma insulin
Time Frame
Fasting insulin on Day 0
Title
Fasting Insulin Day 14
Description
Fasting plasma insulin
Time Frame
Fasting insulin on Day 14
Title
Postprandial Insulin
Description
Plasma insulin concentration area under curve change from baseline
Time Frame
Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Title
Postprandial Glucose
Description
Postprandial plasma glucose concentration area under curve change from baseline
Time Frame
Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Title
Fasting Endotoxin
Description
Fasting serum endotoxin concentration
Time Frame
Day 0
Title
Postprandial Endotoxin
Description
Postprandial serum endotoxin concentration area under curve change from baseline
Time Frame
Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Title
Lactulose/mannitol ratio
Description
Urinary concentration of the non-digestible sugars lactulose/mannitol
Time Frame
Day 14, 0-5 hours post-consumption of sugar probes
Title
Sucralose/erythritol ratio
Description
Urinary concentration of the non-digestible sugars sucralose/erythritol
Time Frame
Day 14, 6-24 hours post-consumption of sugar probes
Title
Fecal butyrate
Description
Fecal concentration of butyrate
Time Frame
Day 14
Title
Fecal acetate
Description
Fecal concentration of acetate
Time Frame
Day 14
Title
Fecal propionate
Description
Fecal concentration of propionate
Time Frame
Day 14
Title
Postprandial Cholecystokinin
Description
Plasma CCK area under curve change from baseline
Time Frame
Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Title
Postprandial glucagon-like peptide-1
Description
Plasma GLP-1 area under curve change from baseline
Time Frame
Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Title
Postprandial Gastric inhibitory peptide
Description
Plasma GIP area under curve change from baseline
Time Frame
Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Title
Fasting cholecystokinin
Description
Fasting plasma concentration of CCK
Time Frame
Day 14
Title
Fasting GLP-1
Description
Fasting plasma concentration of GLP-1
Time Frame
Day 14
Title
Fasting Gastric inhibitory peptide
Description
Fasting plasma concentration of GIP
Time Frame
Day 14
Title
Postprandial NOx
Description
Plasma total nitrite/nitrate area under curve change from baseline
Time Frame
Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Title
Fasting NOx
Description
Fasting plasma concentration of nitrite/nitrate
Time Frame
Day 14
Title
Postprandial Malondialdehyde (MDA)
Description
Plasma MDA concentration, biomarker of oxidative stress area under curve change from baseline
Time Frame
Day 14 postprandial (0, 30, 60, 90, 120 minutes)
Title
Fasting Malondialdehyde (MDA)
Description
Fasting plasma MDA concentration, biomarker of oxidative stress
Time Frame
Day 14
Title
Fasting Vascular Endothelial Function
Description
Fasting flow-mediated dilation of the brachial artery
Time Frame
Day 14
Title
Vitamin C
Description
Fasting vitamin C concentration, biomarker of oxidative stress
Time Frame
Day 14
Title
cIMT
Description
Carotid intima-media thickness
Time Frame
Day 14
Title
Day 0 weight
Description
Weight in kilograms
Time Frame
Day 0
Title
Day 7 weight
Description
Weight in kilograms
Time Frame
Day 7
Title
Day 14 weight
Description
Weight in kilograms
Time Frame
Day 14
Title
Day 0 height
Description
Height in centimeters
Time Frame
Day 0
Title
Day 7 height
Description
Height in centimeters
Time Frame
Day 7
Title
Day 14 height
Description
Height in centimeters
Time Frame
Day 14
Title
Day 0 waist circumference
Description
Waist circumference in centimeters
Time Frame
Day 0
Title
Day 7 waist circumference
Description
Waist circumference in centimeters
Time Frame
Day 7
Title
Day 14 waist circumference
Description
Waist circumference in centimeters
Time Frame
Day 14
Title
Day 0 diastolic blood pressure
Description
Diastolic blood pressure
Time Frame
Day 0
Title
Day 7 diastolic blood pressure
Description
Diastolic blood pressure
Time Frame
Day 7
Title
Day 14 diastolic blood pressure
Description
Diastolic blood pressure
Time Frame
Day 14
Title
Day 0 systolic blood pressure
Description
Systolic blood pressure
Time Frame
Day 0
Title
Day 7 systolic blood pressure
Description
Systolic blood pressure
Time Frame
Day 7
Title
Day 14 systolic blood pressure
Description
Systolic blood pressure
Time Frame
Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Bruno, PhD, RD
Phone
6142921698
Email
bruno.27@osu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Shaw, BS
Phone
5736737269
Email
shaw.876@buckeyemail.osu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Bruno, PhD, RD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Bruno, PhD, RD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data will be published as aggregate only. Data sharing may be possible pending institutional agreements.
Citations:
PubMed Identifier
11176766
Citation
DECODE Study Group, the European Diabetes Epidemiology Group.. Glucose tolerance and cardiovascular mortality: comparison of fasting and 2-hour diagnostic criteria. Arch Intern Med. 2001 Feb 12;161(3):397-405. doi: 10.1001/archinte.161.3.397.
Results Reference
background
PubMed Identifier
25520374
Citation
Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available. Erratum In: Circulation. 2015 Jun 16;131(24):e535. Circulation. 2016 Feb 23;133(8):e417.
Results Reference
background
PubMed Identifier
19960391
Citation
Camire ME, Kubow S, Donnelly DJ. Potatoes and human health. Crit Rev Food Sci Nutr. 2009 Nov;49(10):823-40. doi: 10.1080/10408390903041996.
Results Reference
background
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Cardiometabolic Benefits of Potatoes Mediated Along the Gut-Vessel Axis in Adults With Metabolic Syndrome
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