The Effect of Potatoes on Markers of Cardiometabolic Health

A 2-period randomized cross-over trial will be conducted to determine the effect of incorporating 1 medium size potato, compared to an isocaloric portion of refined grains, on fasting glucose levels, insulin sensitivity, blood pressure, lipids and lipoproteins, arterial stiffness, body weight, gut microbiome, and dietary intake.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Type 2 Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: Potato-based side dish; Dietary supplement: Refined grain-based

Detailed Description

A 2-period randomized cross-over study will be conducted. Free-living subjects will be provided with a potato based side dish (equivalent to one medium sized potato) or an isocaloric refined grain based side dish every day for 4 weeks, in random order. The treatment periods will be separated by a minimum two-week break. Endpoint testing will be conducted over two days at baseline and the end of each diet period.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Pennsylvania State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Non-smoking
• BMI > 20 and <40 kg/m2
• Male or female

Exclusion Criteria:

• Diagnosed diabetes or fasting glucose >126 mg/dl
• Hypertension (systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg)
• Prescribed anti-hypertensive, lipid lowering or glucose lowering drugs
• Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease or inflammatory conditions
• Use of supplements (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals and not willing to cease for the duration of the study
• Pregnancy or lactation
• Weight loss of >=10% of body weight within the 6 months prior to enrolling in the study
• Smoking or use of any tobacco products

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Potato treatment; Participants will be provided with one potato-based side dish, equivalent to one medium sized potato, every day for 4 weeks for incorporation into their self-selected diet. The potato-based side dish will be prepared at the Penn State Metabolic Kitchen. The potato side dish will consist of commonly consumed potato-based sides in the U.S. and there will be limited inclusion of ingredients high in saturated fat, refined sugars or sodium. French fries will not be provided. The variety of potatoes will represent consumption patterns in the U.S. including white, russet, yellow and red potatoes.	Dietary supplement: Potato-based side dish; Daily consumption of a potato-based side dish equivalent to one medium size potato for 4 weeks
Active Comparator: Refined grain treatment; Participants will be provided with a calorie-matched refined grain-based side dish every day for 4 weeks for incorporation into their self-selected diet. The refined grain-based side dishes will be prepared at the Penn State Metabolic Kitchen and ingredients high in saturated fat, refined sugar or sodium will not be used. These will be sides commonly eaten in the U.S. (e.g. pasta made with white flour and white rice, white bread rolls). During this treatment, participants will be told not to consume potatoes.	Dietary supplement: Refined grain-based; Daily consumption of an isocaloric refined grain-based side dish for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fasting blood glucose	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Triglycerides	4 weeks
Total cholesterol	4 weeks
LDL cholesterol	4 weeks
Homeostasis Model of Assessment of Insulin Resistance	4 weeks
Peripheral blood pressure	4 weeks
Central blood pressure	4 weeks
Pulse Wave Velocity	4 weeks
Augmentation index	4 weeks
Diet quality measured by the Healthy Eating Index 2010	4 weeks
Change in fecal short chain fatty acid levels	Week 0; Week 2 of treatment period 1; Week 4 of treatment period 1; Week 2 of treatment 2; Week 4 of treatment 4
Change in microbiome composition	Week 0; Week 2 of treatment period 1; Week 4 of treatment period 1; Week 2 of treatment 2; Week 4 of treatment 4
HDL cholesterol	4 weeks

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: Alliance for Potato Research and Education
• Investigators: Principal Investigator: Penny M Kris-Etherton, PhD, Penn State University

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2018
• Primary Completion (Actual): May 19, 2019
• Study Completion (Actual): January 19, 2020

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: April 4, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Cardiovascular Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: PKE POTATO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No