Clinical Trial

Effect of a Protein-Creatine-Omega3-Vitamin D Supplement on Glycemic Variability in Mexican Patients With Type 2 Diabetes

Study acronym: PROVID-DM
Not Yet Recruiting
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Record status
This record was last updated April 13, 2025 (before its estimated May 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
This study aims to evaluate the effect of a daily nutritional supplement containing whey protein, creatine, omega-3 fatty acids, and vitamin D on blood sugar fluctuations in adults with recently diagnosed type 2 diabetes. Forty participants will be enrolled in a 12-week, double-blind, randomized clinical trial. Half of the participants will receive the supplement, while the other half will receive a placebo. Blood sugar levels will be monitored using continuous glucose monitoring (CGM) devices placed at five different time points during and after the intervention. The study will also measure changes in HbA1c, body composition, metabolic biomarkers, and gut microbiota. Participants will receive medical follow-up and support for six months after the study. The goal is to explore whether this supplement can help stabilize glucose levels and support early management of diabetes.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-07.
Trial Details
NCT Number NCT06920667
Lead Sponsor Héctor Iván Saldívar Cerón
Collaborators: University of Illinois at Chicago
Conditions Type 2 Diabetes Mellitus
Enrollment 40 participants
Start Date 2025-06-01
Primary Completion 2026-05-01 (estimated)
Study Completion 2026-10-25 (estimated)
Updated on ClinicalTrials.gov 2025-04-13