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A diet designed for puerto rico: can traditional foods fight heart disease and diabetes?

NCT ID NCT05962372

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This trial tests whether a diet adapted to Puerto Rican culture can lower the risk of heart disease, type 2 diabetes, and obesity. Researchers will compare culturally tailored nutrition advice—emphasizing traditional healthy foods and limiting unhealthy ones—with standard healthy eating guidelines. The study enrolls 250 adults aged 30–65 in Puerto Rico who have at least one risk factor like high blood pressure, high blood sugar, or excess weight.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
culturally tailored food and diet advice
What this could lead to
If it works, this could point toward a practical, culturally appropriate diet plan that reduces heart disease, diabetes, and obesity risks in Puerto Rican adults.
What could go wrong
This is a behavioral intervention trial with 250 participants, so results may not apply broadly. Diet changes can be hard to sustain long-term, and the study relies on self-reported data.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 30-65y old at the time of enrollment 2. Non-institutionalized 3. Living in PR at the time of recruitment and for at least the previous year and not planning to move from the island within the next 3 years 4. Able to answer questions without assistance 5. Having a cellphone with the capacity to receive text messages and be willing to receive daily text messages from the study on the designated cellphone number 6. Having at least one of the following: 1. elevated BMI 2. elevated waist circumference 3. self-reported physician-diagnosed hypertension or use of hypertension medication or measured high blood pressure at the baseline visit 4. self-reported physician-diagnosed pre-diabetes or measured pre-diabetes at the baseline visit 5. self-reported physician-diagnosed dyslipidemia or use of lipid-lowering agents or laboratory values confirming dyslipidemia Exclusion Criteria: 1. Under 30 or over 65 years of age (on the day of the interview). 2. Currently not living in Puerto Rico or not lived on the island for at least 1 year or planning to move within 3 years 3. Institutionalized 4. Not able to answer questions without assistance 5. Not having at least 1 of the five listed metabolic criteria 6. Self-reported physician-diagnosed type 1 or type 2 diabetes or use of diabetes medication (including insulin) or diabetes-diagnosis values confirmed by laboratory 7. Self-reported pregnancy 8. Gastrointestinal or chronic condition that would impact eating behaviors or nutritional status 9. Intolerance or allergies to legumes (i.e.: beans and nuts), vegetable oils (i.e.: corn, olive, canola), or fresh produce 10. Living with another person participating in the study 11. Participating in another research study that conflicts with PRECISION

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Puerto Rico Consortium for Clinical Investigation

    RECRUITING

    San Juan, 00926, Puerto Rico

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