Who is sponsoring NCT03975556?

NCT03975556 is sponsored by Harvard School of Public Health (HSPH).

What drugs are being tested in NCT03975556?

Interventions in NCT03975556: Culturally tailored food and diet advice, Standard healthy eating advice.

What condition does NCT03975556 study?

NCT03975556 studies Diabetes Mellitus, Type 2, Obesity, Hypertension, Dyslipidemias, High Triglycerides, High Blood Glucose, Abdominal Obesity.

Is NCT03975556 still recruiting?

NCT03975556 is currently completed. Last updated 23 July 2021.

Last reviewed 2021-07-23 · How we verify

NCT03975556

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Culturally-Adapted Diet for Puerto Rican Adults

Completed NA Last updated 23 July 2021

What this trial tests

NA trial testing Culturally tailored food and diet advice in Diabetes Mellitus, Type 2 in 45 participants. Completed in 30 June 2021.

Timeline

1 July 2019

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	Harvard School of Public Health (HSPH)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	45
Start date	1 July 2019
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	1 location across Puerto Rico

Drugs / interventions tested

Culturally tailored food and diet advice
Standard healthy eating advice

Conditions studied

Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Obesity — all drugs for Obesity →
Hypertension — all drugs for Hypertension →
Dyslipidemias — all drugs for Dyslipidemias →

Sponsor

Harvard School of Public Health (HSPH)

Who can join

Adults 25 to 65, any sex, with Diabetes Mellitus, Type 2 or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This pilot project will determine whether a diet culturally-adapted to Puerto Ricans can effectively decrease cardiometabolic risk for diabetes. This will help define a culturally-appropriate, feasible, and sustainable diet intervention aimed at reducing type 2 diabetes and obesity outcomes.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Design and Implementation of a Culturally-Tailored Randomized Pilot Trial: Puerto Rican Optimized Mediterranean-Like Diet.
Mattei J, Díaz-Alvarez CB, Alfonso C, O'Neill HJ, et al · · 2023 · cited 11× · PMID 37181130 · DOI 10.1016/j.cdnut.2022.100022
Racial and Ethnic Disparities in NAFLD: Harnessing Epigenetic and Gut Microbiota Pathways for Targeted Therapeutic Approaches.
Zaiou M, Joubert O. · · 2025 · cited 2× · PMID 40427561 · DOI 10.3390/biom15050669

Verify or expand the search:

Other trials of Culturally tailored food and diet advice

Trials testing the same drug.

NCT05962372 — Culturally Adapted Dietary Clinical Trial in PR · NA · recruiting

Other recruiting trials for Diabetes Mellitus, Type 2

Currently open trials in the same condition.

NCT07415954 — A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 · Phase 2 · recruiting
NCT07532863 — A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Part · recruiting
NCT07336329 — Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use · NA · recruiting
NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) · Phase 1 · recruiting
NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0 · recruiting

Other Harvard School of Public Health (HSPH) trials

Trials by the same sponsor.

NCT07493772 — Multiple Micronutrient Supplementation With Digital Layering Among Adolescents in Tanzania · NA · not yet recruiting
NCT06982339 — Beat the Heat Boston · NA · recruiting
NCT06765863 — LIFT-UP: Randomized Controlled Trial of Fortification of Human Milk · NA · recruiting
NCT06102044 — Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania · Phase 3 · recruiting
NCT06390943 — Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package: Implementation Research · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03975556 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Harvard School of Public Health (HSPH)
Last refreshed: 23 July 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03975556.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing