NCT07734948

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Aug 2026

Status
not yet recruiting

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

July 24, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

12 months

First QC Date

July 24, 2026

Last Update Submit

July 24, 2026

Conditions

PRE-HYPERTENSION

Keywords

Purple flesh PotatoPre-hypertensionCardiovascular diseaseMenPotato

Outcome Measures

Primary Outcomes (1)

  • Changes in blood pressure

    8 weeks (4 weeks per treatment)

Secondary Outcomes (4)

  • Changes in lipid profile

    8 weeks (4 weeks per treatment)

  • Changes in fasting glucose

    8 weeks (4 weeks per treatment)

  • Changes in plasma antioxidant capacity

    8 weeks (4 weeks per treatment)

  • Changes in CRP

    8 weeks (4 weeks per treatment)

Other Outcomes (1)

  • Changes in oral microbiome diversity

    8 weeks (4 weeks per treatment)

Study Arms (2)

Intervention group

EXPERIMENTAL
Other: Purple flesh potato

Control group

PLACEBO COMPARATOR
Other: White flesh potato

Interventions

Purple flesh potatoOTHER

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

Intervention group
White flesh potatoOTHER

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

Control group

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PrehypertensionCardiovascular DiseasesMultiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Vascular DiseasesMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Central Study Contacts

Maria R Liria-Dominguez, PhD

CONTACT

5113496023rliria@iin.sld.pe

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2026

First Posted

July 29, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

July 29, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share