The Effect of Potatoes on Markers of Cardiometabolic Health

Penn State University51 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Type 2 Diabetes Mellitus Cardiovascular Diseases

Interventions

Potato-based side dishDIETARY_SUPPLEMENT

Daily consumption of a potato-based side dish equivalent to one medium size potato for 4 weeks

Refined grain-basedDIETARY_SUPPLEMENT

Daily consumption of an isocaloric refined grain-based side dish for 4 weeks

Eligibility

Sex: ALLMin age: 25 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pennsylvania State University

University Park, Pennsylvania, United States

Outcomes

Primary Outcomes

Fasting blood glucose

Time frame: 4 weeks

Secondary Outcomes

Homeostasis Model of Assessment of Insulin Resistance

Time frame: 4 weeks

Peripheral blood pressure

Time frame: 4 weeks

Central blood pressure

Time frame: 4 weeks

Total cholesterol

Time frame: 4 weeks

Pulse Wave Velocity

Time frame: 4 weeks

Augmentation index

Time frame: 4 weeks

Diet quality measured by the Healthy Eating Index 2010

Time frame: 4 weeks

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

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

LDL cholesterol

Time frame: 4 weeks

HDL cholesterol

Time frame: 4 weeks

Data from ClinicalTrials.gov

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