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The Effect of Potatoes on Markers of Cardiometabolic Health

Primary Purpose

Type 2 Diabetes Mellitus, Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Potato-based side dish
Refined grain-based
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes Mellitus

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pennsylvania State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Potato treatment

Refined grain treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Fasting blood glucose

Secondary Outcome Measures

Homeostasis Model of Assessment of Insulin Resistance
Peripheral blood pressure
Central blood pressure
Total cholesterol
Pulse Wave Velocity
Augmentation index
Diet quality measured by the Healthy Eating Index 2010
Change in fecal short chain fatty acid levels
Change in microbiome composition
LDL cholesterol
HDL cholesterol
Triglycerides

Full Information

First Posted
January 15, 2018
Last Updated
August 15, 2023
Sponsor
Penn State University
Collaborators
Alliance for Potato Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT03495284
Brief Title
The Effect of Potatoes on Markers of Cardiometabolic Health
Official Title
The Effect of Potatoes on Markers of Cardiometabolic Health
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 19, 2018 (Actual)
Primary Completion Date
May 19, 2019 (Actual)
Study Completion Date
January 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Penn 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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Cardiovascular Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Potato treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Refined grain treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Potato-based side dish
Intervention Description
Daily consumption of a potato-based side dish equivalent to one medium size potato for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Refined grain-based
Intervention Description
Daily consumption of an isocaloric refined grain-based side dish for 4 weeks
Primary Outcome Measure Information:
Title
Fasting blood glucose
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Homeostasis Model of Assessment of Insulin Resistance
Time Frame
4 weeks
Title
Peripheral blood pressure
Time Frame
4 weeks
Title
Central blood pressure
Time Frame
4 weeks
Title
Total cholesterol
Time Frame
4 weeks
Title
Pulse Wave Velocity
Time Frame
4 weeks
Title
Augmentation index
Time Frame
4 weeks
Title
Diet quality measured by the Healthy Eating Index 2010
Time Frame
4 weeks
Title
Change in fecal short chain fatty acid levels
Time Frame
Week 0; Week 2 of treatment period 1; Week 4 of treatment period 1; Week 2 of treatment 2; Week 4 of treatment 4
Title
Change in microbiome composition
Time Frame
Week 0; Week 2 of treatment period 1; Week 4 of treatment period 1; Week 2 of treatment 2; Week 4 of treatment 4
Title
LDL cholesterol
Time Frame
4 weeks
Title
HDL cholesterol
Time Frame
4 weeks
Title
Triglycerides
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Penny M Kris-Etherton, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennsylvania State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Potatoes on Markers of Cardiometabolic Health

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