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.
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.
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.
- Conditions
- PRE-HYPERTENSION
- 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 group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Other: Purple flesh potato |
| Control group | Placebo comparator | Not described Receives: Other: White flesh potato |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood pressure
Measured: 8 weeks (4 weeks per treatment)
Secondary outcomes (4)
Changes in lipid profile
Measured: 8 weeks (4 weeks per treatment)
Changes in fasting glucose
Measured: 8 weeks (4 weeks per treatment)
Changes in plasma antioxidant capacity
Measured: 8 weeks (4 weeks per treatment)
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.
- First posted29 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PRE-HYPERTENSIONStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Nutricional, Peru
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Internacional de la Papa, University of California, Davis
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Biomarkers and Plasma Metabolites Variation Induced by Purple Fleshed Potatoes Consumption in Prehypertensive Men
- ClinicalTrials.gov ID
- NCT07734948
- Acronym / sponsor ID
- 440-2026/CIEI-IIN
- Conditions
- PRE-HYPERTENSION
- Keywords
- Purple flesh Potato, Pre-hypertension, Cardiovascular disease, Men, Potato
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Instituto de Investigacion Nutricional, PeruUniversity, hospital or other
- Collaborators
- Centro Internacional de la Papa, University of California, Davis
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Jul 2026 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Purple flesh potato |
| Control group | Placebo comparator | Other: White flesh potato |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Purple flesh potatoDietary Intervention: Purple flesh potato pureé, rich in anthocyanins food Dietary Intervention: white flesh potato pureé, control | Other | Intervention group |
| White flesh potatoDietary Intervention: Purple flesh potato puree, rich in anthocyanins food Dietary Intervention: white flesh potato puree, control | Other | Control group |
Primary outcome
Changes in blood pressure
Time frame: 8 weeks (4 weeks per treatment)
4 secondary outcomes
Changes in lipid profile
Time frame: 8 weeks (4 weeks per treatment)
Changes in fasting glucose
Time frame: 8 weeks (4 weeks per treatment)
Changes in plasma antioxidant capacity
Time frame: 8 weeks (4 weeks per treatment)
Changes in CRP
Time frame: 8 weeks (4 weeks per treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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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.
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.