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

NCT03624569 | Completed Results

• 1 other identifier: 2018H0265
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Endotoxin

  Fasting serum endotoxin concentration

  Day 14

• 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)

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

Secondary Outcomes (30)

• Fasting Glucose Day 0

  Fasting glucose on Day 0

• Fasting Glucose Day 14

  Fasting glucose on Day 14

• Fasting Insulin Day 0

  Fasting insulin on Day 0

• Fasting Insulin Day 14

  Fasting insulin on Day 14

• Postprandial Insulin

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

Study Arms (2)

Bagel diet

SHAM COMPARATOR

Bagel consumed daily for 2 weeks

Other: Bagel

Potato diet

EXPERIMENTAL

Potato consumed daily for 2 weeks

Other: Potato

Interventions

Bagel OTHER

A bagel will be consumed daily for 2 weeks.

Bagel diet

Potato OTHER

A potato will be consumed daily for 2 weeks.

Potato diet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• Alliance for Potato Research and Education: collaborator

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Cao S, Shaw EL, Quarles WR, Sasaki GY, Dey P, Hodges JK, Pokala A, Zeng M, Bruno RS. Daily Inclusion of Resistant Starch-Containing Potatoes in a Dietary Guidelines for Americans Dietary Pattern Does Not Adversely Affect Cardiometabolic Risk or Intestinal Permeability in Adults with Metabolic Syndrome: A Randomized Controlled Trial. Nutrients. 2022 Apr 8;14(8):1545. doi: 10.3390/nu14081545.

  PMID: 35458108 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Endotoxemia; Hyperglycemia

Condition Hierarchy (Ancestors)

Bacteremia; Sepsis; Infections; Toxemia; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Richard Bruno, Principal Investigator
• Organization: The Ohio State University

bruno.27@osu.edu

6142925522

Study Officials

• Richard Bruno, PhD, RD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 10, 2018
• Study Start: August 15, 2018
• Primary Completion: July 16, 2020
• Study Completion: July 16, 2020
• Last Updated: June 15, 2025
• Results First Posted: June 15, 2025

Record last verified: 2025-06

Locations

US (1)