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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03624569
• Other study ID #: 2018H0265
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: July 2020

Study information

• Verified date: January 2020
• Source: Ohio State University
• Contact: Richard Bruno, PhD, RD
• Phone: 6142921698
• Email: bruno.27[@]osu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Endothelial Dysfunction
• Endotoxemia
• Gut Health
• Hyperglycemia
• Metabolic Syndrome
• Postprandial Hyperglycemia

Intervention

Other:
• Bagel
A bagel will be consumed daily for 2 weeks.
• Potato
A potato will be consumed daily for 2 weeks.

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Alliance for Potato Research and Education

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Review. — View 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. — View Citation

Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Després 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. Erratum in: Circulation. 2015 Jun 16;131(24):e535. Circulation. 2016 Feb 23;133(8):e417. — View Citation

Outcome

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