Potatoes, Hypertension RIsk and Endothelial Function Study

Endothelial Dysfunction Clinical Trial

— PHRIES  

Official title:

Potatoes, Hypertension RIsk and Endothelial Function Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03116919
• Other study ID #: 2017P000405
• Status: Completed
• Phase: N/A
• Start date: February 15, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: January 2021
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

White potatoes have recently been allowed back in the cash value voucher of the government food stamp program after it was stated that there were no known adverse health effects of potatoes. However, the association of potatoes with heart health, especially elevated blood pressure is not known. This study will examine the effects of potatoes on blood pressure in different populations of adults and children, and assess, in a feeding trial, the effects of an additional serving of potatoes per day on the possible mechanisms that link potatoes to high blood pressure. The investigators will also analyze the intake of potatoes in participants of the government food stamp program.

Description:

Potatoes are one of the most consumed vegetables in the US and the world. In recent years, several changes have been made to government sponsored food programs with respect to potatoes, such as lifting the restriction on the number of servings of starchy vegetables (including potatoes) established by the Healthy Hunger-Free Act, and re-allowing white potatoes in the cash-value voucher for fruits and vegetables of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), after the Institute of Medicine asserted that there was insufficient evidence that white potatoes had adverse health effects. However, the investigators recently reported an increased incidence of hypertension with increasing potato consumption in three large prospective US cohort studies after adjusting for sodium intake and other potential confounders. The investigators also analyzed the association of short-term potato intake from a 24-hr dietary recall with endothelial-dependent vasodilation measured by brachial artery ultrasonography in the Modifiable Effectors of Renin System Activation Treatment Evaluation (MODERATE) trial. Participants who consumed one or more than one serving of boiled, baked or mashed potatoes during the previous day had a 1.7% lower endothelial-dependent vasodilation when compared with participants with no potato intake (p-value= 0.01) after adjusting for other factors. This is a relevant difference in endothelial function - by comparison, every 10 year increase in age was associated with a 1.2% lower endothelial function. Therefore, the investigators plan to analyze the effect of one serving of boiled, baked or mashed potato per day on endothelial function in a crossover feeding trial of healthy adult men and women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 18-45 years of age

• without known cardiovascular risk factor

Exclusion Criteria:

• History of hypertension, diabetes or cardiovascular disease

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Hypertension

Intervention

Other:
• Potato
Participants will be given an extra serving of potato a day
• Non-starchy vegetable
Participants will be given an extra serving of a non-starchy vegetable

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial function assessed by endothelium-dependent vasodilation using brachial artery ultrasonography	Change in endothelial function after eating potato or non-starchy vegetable	1 week