NCT03116919

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

February 15, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

April 10, 2017

Last Update Submit

January 25, 2021

Conditions

Endothelial Dysfunction

Keywords

nutritionPotatoesendothelial functionfeeding trial

Outcome Measures

Primary Outcomes (1)

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

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

    1 week

Study Arms (2)

Potato arm

OTHER

One group will be fed an extra serving of boiled, baked or mashed potatoes daily for 1 week

Other: Potato

Non-starchy vegetable

OTHER

Then crossover to an extra serving of a non-starchy vegetable

Other: Non-starchy vegetable

Interventions

PotatoOTHER

Participants will be given an extra serving of potato a day

Potato arm
Non-starchy vegetableOTHER

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

Non-starchy vegetable

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • without known cardiovascular risk factor

You may not qualify if:

  • History of hypertension, diabetes or cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Study Officials

  • Lea Borgi, MD, MMSc

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Crossover feeding trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Physician, Renal Division, Department of Medicine

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 17, 2017

Study Start

February 15, 2018

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations

US(1)