The Effect of Potatoes on Markers of Cardiometabolic Health

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Potatoes on Markers of Cardiometabolic Health

Conditions
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Type 2 Diabetes Mellitus, Cardiovascular Diseases

Intervention / Treatment
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* Dietary Supplement: Potato-based side dish
* Dietary Supplement: Refined grain-based


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Potato treatment<br>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<br>* Daily consumption of a potato-based side dish equivalent to one medium size potato for 4 weeks<br>|
| Active Comparator: Refined grain treatment<br>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<br>* Daily consumption of an isocaloric refined grain-based side dish for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood glucose |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homeostasis Model of Assessment of Insulin Resistance |  | 4 weeks | 
| Peripheral blood pressure |  | 4 weeks | 
| Central blood pressure |  | 4 weeks | 
| Total cholesterol |  | 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 | 
| LDL cholesterol |  | 4 weeks | 
| HDL cholesterol |  | 4 weeks | 
| Triglycerides |  | 4 weeks |