Status:
NOT_YET_RECRUITING
Effect of a Protein-Creatine-Omega3-Vitamin D Supplement on Glycemic Variability in Mexican Patients With Type 2 Diabetes
Lead Sponsor:
Héctor Iván Saldívar Cerón
Collaborating Sponsors:
University of Illinois at Chicago
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 diagn...
Detailed Description
This randomized, double-blind, placebo-controlled clinical trial will evaluate the impact of a combined supplement-composed of whey protein, creatine monohydrate, omega-3 fatty acids (EPA/DHA), and vi...
Eligibility Criteria
Inclusion
- Adults aged 18-65 years
- Diagnosis of type 2 diabetes mellitus within the past 5 years
- HbA1c between 7.0% and 10.0%
- BMI between 25 and 40 kg/m²
- On metformin monotherapy or no glucose-lowering medications
- Willing to follow study instructions and attend all scheduled visits
- Able to provide written informed consent
Exclusion
- Use of insulin or other antidiabetic medications beyond metformin
- History of type 1 diabetes, pancreatitis, or major GI surgery
- Severe renal, hepatic, or cardiovascular disease
- Use of supplements with whey protein, creatine, omega-3, or vitamin D in the past 3 months
- Known allergy to supplement/placebo ingredients
- Participation in another clinical trial within the past 3 months
- Pregnancy or breastfeeding
- Any condition that, in the investigator's judgment, may interfere with study participation
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 25 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06920667
Start Date
June 1 2025
End Date
October 25 2026
Last Update
April 13 2025
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