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PRE-HYPERTENSIONNCT07734948

Cardiovascular Effects of Purple-Fleshed Potatoes

A study testing Purple flesh potato and White flesh potato in people with PRE-HYPERTENSION, run by Instituto de Investigacion Nutricional, Peru.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study is being done to evaluate the effect on cardiovascular biomarkers and anthocyanin-derived plasma metabolites of Peruvian native purple-fleshed potato consumed over a 4-week period by prehypertensive men ages 18-40 years old. Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
PRE-HYPERTENSION
What is being tested?
Purple flesh potato and White flesh potato
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
No sites listed yet
Study dates
1 Aug 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Men aged 18-40 years.
  • BMI between 18.5 and 35 kg/m².
  • Prehypertensive individuals with systolic blood pressure (SBP) of 120-139 mmHg and/or diastolic blood pressure (DBP) of 80-89 mmHg.
  • Fasting glucose ≤125 mg/dL.
  • Willing to attend the study center for 42 days for potato consumption and measurement procedures.
  • Willing to consume the equivalent of 400 g of fresh potatoes daily during two 4-week periods, separated by a 7-day washout period.
  • Individuals who agree to and sign the informed consent form.
  • Not taking blood pressure-lowering and/or cholesterol-lowering medications. Smokers. Taking supplements containing antioxidants. Engaging in high-intensity physical activity according to the short version of the International Physical Activity Questionnaire (IPAQ).

Who cannot join

  • Individuals with chronic gastrointestinal disorders, kidney disease, or diabetes, previously diagnosed or identified through screening via a questionnaire.
  • Individuals currently taking antibiotics, nonsteroidal anti-inflammatory drugs (NSAIDs), blood pressure medications, and/or cholesterol-lowering medications.
  • Participants who do not complete the study or who develop an acute health condition during the study period.
  • Participants with C-reactive protein (CRP) levels > 10 mg/L. Smokers.
  • Taking supplements containing antioxidants.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Maria R Liria-Dominguez, PhD contact

5113496023

rliria@iin.sld.pe

About this study

Official title: Cardiovascular Biomarkers and Plasma Metabolites Variation Induced by Purple Fleshed Potatoes Consumption in Prehypertensive Men

This study is being done to evaluate the effect on cardiovascular biomarkers and anthocyanin-derived plasma metabolites of Peruvian native purple-fleshed potato consumed over a 4-week period by prehypertensive men ages 18-40 years old. Subjects will undergo blood pressure monitoring, anthropometric measurements, laboratory analysis, plasma metabolic profile assessments and microbiome metagenomic analysis before and after finishing the potato consumption period.

Hypertension is a chronic disease that affects over 20% of Peruvians aged 15+, with higher prevalence in men. Previous studies on purple flesh varieties have shown reductions in blood pressure and improvements in vascular function. Potatoes are a major dietary staple and a source of many compounds beyond carbohydrates, including vitamins, minerals, and polyphenols. Anthocyanins are polyphenol compounds that give purple potatoes their color, and are known for its antioxidant, anti-inflammatory, and vasodilatory properties. Hence, this work aims to generate novel evidence on the cardiovascular benefits of Peruvian purple flesh potatoes that could lead to its inclusion on preventive dietary strategies and enhance the value of local agriculture. Moreover, as purple flesh potatoes have unique anthocyanins such as petunidin and peonidin whose metabolization has not yet been studied, understanding their metabolization and bioavailability will aid in a better understanding of their observed impact on health.

The study is designed as a randomized, controlled, crossover nutritional intervention involving 30 male prehypertensive participants aged 18-40 (BMI < 30 kg/m2, 120-139 mmHg SBP and/or 80-89 mmHg DBP), with an expected final sample of 21. Each participant will consume a daily portion over a four-week period of potato purée of either purple- or white-fleshed varieties according to the corresponding treatment, with a one-week washout period between treatments. The portion will consist of a rehydrated purée derived from freeze-dried steamed tubers equivalent to 400 grams of fresh weight. All measurements will be taken before each treatment period beginning and after its ending. Anthropometry measurements will include waist circumference, height and weight to calculate BMI. Blood pressure will be measured at fasting and postprandial state. Blood samples will be taken at fasten state for measuring biochemical markers glucose, lipid profile, creatinine, C-reactive protein, and antioxidant capacity. Saliva samples will be taken at fasten state for microbiome analysis. Blood samples for plasma metabolomic analysis will be taken at fasten state before the intervention as a basal measurement and after potato consumption (1 postprandial hour) on the treatment last day. Dietary intake and physical activity will be monitored using 24-hour recall and IPAQ short form questionnaires.

Being tested
Purple flesh potato, White flesh potato
Keywords
Purple flesh Potato, Pre-hypertension, Cardiovascular disease, Men, Potato
Medical subject headings
Prehypertension, Cardiovascular Diseases, Multiple Endocrine Neoplasia Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Purple flesh potatoOther

    Dietary Intervention: Purple flesh potato pureé, rich in anthocyanins food Dietary Intervention: white flesh potato pureé, control

  • White flesh potatoOther

    Dietary Intervention: Purple flesh potato puree, rich in anthocyanins food Dietary Intervention: white flesh potato puree, control

Study groups in NCT07734948
Study groupRoleWhat they receive
Intervention groupExperimentalNot described
Receives: Other: Purple flesh potato
Control groupPlacebo comparatorNot described
Receives: Other: White flesh potato

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in blood pressure

    Measured: 8 weeks (4 weeks per treatment)

Secondary outcomes (4)
  1. Changes in lipid profile

    Measured: 8 weeks (4 weeks per treatment)

  2. Changes in fasting glucose

    Measured: 8 weeks (4 weeks per treatment)

  3. Changes in plasma antioxidant capacity

    Measured: 8 weeks (4 weeks per treatment)

  4. Changes in CRP

    Measured: 8 weeks (4 weeks per treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07734948
Sponsor's protocol ID
440-2026/CIEI-IIN
Status last verified
Jul 2026
First submitted
24 Jul 2026
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Purple flesh potato and White flesh potato in people with PRE-HYPERTENSION, run by Instituto de Investigacion Nutricional, Peru.

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 8 inclusion and 5 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: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maria R Liria-Dominguez, PhD (5113496023, rliria@iin.sld.pe), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in blood pressure (time frame: 8 weeks (4 weeks per treatment)). 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 29 Jul 2026.

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