The Effect of Potatoes on Markers of Cardiometabolic Health

Cardiovascular Diseases Clinical Trial

Official title:

The Effect of Potatoes on Markers of Cardiometabolic Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03495284
• Other study ID #: PKE POTATO
• Status: Completed
• Phase: N/A
• Start date: February 19, 2018
• Est. completion date: January 19, 2020

Study information

• Verified date: August 2023
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 19, 2020
• Est. primary completion date: May 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Potato-based side dish
Daily consumption of a potato-based side dish equivalent to one medium size potato for 4 weeks
• Refined grain-based
Daily consumption of an isocaloric refined grain-based side dish for 4 weeks

Locations

Country	Name	City	State
United States	Pennsylvania State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	Alliance for Potato Research and Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting blood glucose		4 weeks
Secondary	Homeostasis Model of Assessment of Insulin Resistance		4 weeks
Secondary	Peripheral blood pressure		4 weeks
Secondary	Central blood pressure		4 weeks
Secondary	Total cholesterol		4 weeks
Secondary	Pulse Wave Velocity		4 weeks
Secondary	Augmentation index		4 weeks
Secondary	Diet quality measured by the Healthy Eating Index 2010		4 weeks
Secondary	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
Secondary	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
Secondary	LDL cholesterol		4 weeks
Secondary	HDL cholesterol		4 weeks
Secondary	Triglycerides		4 weeks