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The Effect of Potatoes on Markers of Cardiometabolic Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495284
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : March 30, 2020
Sponsor:
Collaborator:
Alliance for Potato Research and Education
Information provided by (Responsible Party):
Penny, Penn State University

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Cardiovascular Diseases Dietary Supplement: Potato-based side dish Dietary Supplement: Refined grain-based Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Potatoes on Markers of Cardiometabolic Health
Actual Study Start Date : February 19, 2018
Actual Primary Completion Date : May 19, 2019
Actual Study Completion Date : January 19, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Fasting blood glucose [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Homeostasis Model of Assessment of Insulin Resistance [ Time Frame: 4 weeks ]
  2. Peripheral blood pressure [ Time Frame: 4 weeks ]
  3. Central blood pressure [ Time Frame: 4 weeks ]
  4. Total cholesterol [ Time Frame: 4 weeks ]
  5. Pulse Wave Velocity [ Time Frame: 4 weeks ]
  6. Augmentation index [ Time Frame: 4 weeks ]
  7. Diet quality measured by the Healthy Eating Index 2010 [ Time Frame: 4 weeks ]
  8. 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 ]
  9. 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 ]
  10. LDL cholesterol [ Time Frame: 4 weeks ]
  11. HDL cholesterol [ Time Frame: 4 weeks ]
  12. Triglycerides [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495284


Locations
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United States, Pennsylvania
Pennsylvania State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
Alliance for Potato Research and Education
Investigators
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Principal Investigator: Penny M Kris-Etherton, PhD Penn State University
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Responsible Party: Penny, Distinguished Professor of Nutrition, Penn State University
ClinicalTrials.gov Identifier: NCT03495284    
Other Study ID Numbers: PKE POTATO
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases