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Completed

NCT Number: NCT03116919

Potatoes, Hypertension RIsk and Endothelial Function Study

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-45 years of age
  • without known cardiovascular risk factor

Exclusion criteria

  • History of hypertension, diabetes or cardiovascular disease

Treatment and study plan

Potato

Other

Participants will be given an extra serving of potato a day

Non-starchy vegetable

Other

Participants will be given an extra serving of a non-starchy vegetable

Primary outcomes

  1. Endothelial function assessed by endothelium-dependent vasodilation using brachial artery ultrasonography

    Time frame: 1 week

    Change in endothelial function after eating potato or non-starchy vegetable

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Acronym: PHRIES

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 17, 2017
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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