Endothelial DysfunctionPHRIESNCT03116919
Potatoes, Hypertension RIsk and Endothelial Function Study
A study testing Potato and Non-starchy vegetable in people with Endothelial Dysfunction, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- Potato and Non-starchy vegetable
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2018to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 years of age
- without known cardiovascular risk factor
Who cannot join
- History of hypertension, diabetes or cardiovascular disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this 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.
Read the detailed 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.
- Conditions
- Endothelial Dysfunction
- Being tested
- Potato, Non-starchy vegetable
- Keywords
- nutrition, Potatoes, endothelial function, feeding trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PotatoOther
Participants will be given an extra serving of potato a day
Non-starchy vegetableOther
Participants will be given an extra serving of a non-starchy vegetable
| Study group | Role | What they receive |
|---|---|---|
| Potato arm | Other | One group will be fed an extra serving of boiled, baked or mashed potatoes daily for 1 week Receives: Other: Potato |
| Non-starchy vegetable | Other | Then crossover to an extra serving of a non-starchy vegetable Receives: Other: Non-starchy vegetable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function assessed by endothelium-dependent vasodilation using brachial artery ultrasonography
Change in endothelial function after eating potato or non-starchy vegetable
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start15 Feb 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover feeding trial
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lea Borgi, Brigham and Women's Hospital
- Investigators
- Lea Borgi, MD, MMSc, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116919
- Sponsor's protocol ID
- 2017P000405
- Acronym
- PHRIES
- Status last verified
- Jan 2021
- First submitted
- 10 Apr 2017
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potatoes, Hypertension RIsk and Endothelial Function Study
- ClinicalTrials.gov ID
- NCT03116919
- Acronym / sponsor ID
- PHRIES / 2017P000405
- Conditions
- Endothelial Dysfunction
- Keywords
- nutrition, Potatoes, endothelial function, feeding trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 17 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossover feeding trial
| Arm | Type | Receives |
|---|---|---|
| Potato arm | Other | Other: PotatoOne group will be fed an extra serving of boiled, baked or mashed potatoes daily for 1 week |
| Non-starchy vegetable | Other | Other: Non-starchy vegetableThen crossover to an extra serving of a non-starchy vegetable |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-45 years of age
- without known cardiovascular risk factor
Key exclusion criteria (1 listed)
- History of hypertension, diabetes or cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PotatoParticipants will be given an extra serving of potato a day | Other | Potato arm |
| Non-starchy vegetableParticipants will be given an extra serving of a non-starchy vegetable | Other | Non-starchy vegetable |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lea Borgi, MD, MMSc principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Potato and Non-starchy vegetable in people with Endothelial Dysfunction, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial function assessed by endothelium-dependent vasodilation using brachial artery ultrasonography (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.