Effect of a Protein-Creatine-Omega3-Vitamin D Supplement on Glycemic Variability in Mexican Patients With Type 2 Diabetes
Launched by HÉCTOR IVÁN SALDÍVAR CERÓN · Apr 7, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the effects of a daily nutritional supplement on blood sugar stability in adults with type 2 diabetes. The supplement contains whey protein, creatine, omega-3 fatty acids, and vitamin D, and the goal is to see if it can help reduce fluctuations in blood sugar levels. Forty participants aged 18 to 65, who have been diagnosed with type 2 diabetes in the last five years and are either taking metformin or no diabetes medications, may qualify for this study.
Participants will be divided into two groups: one will receive the supplement, while the other will get a placebo (a non-active treatment). Over 12 weeks, researchers will monitor blood sugar levels using special devices and will also look at other health markers, body composition, and gut health. Participants will get medical follow-up and support for six months after the study ends. This trial is currently not recruiting, but it aims to explore new ways to help manage diabetes early on.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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
About Héctor Iván Saldívar Cerón
Héctor Iván Saldívar Cerón is a dedicated clinical trial sponsor committed to advancing medical research and innovation. With a focus on enhancing patient outcomes, he oversees the design, implementation, and management of clinical studies, ensuring adherence to regulatory standards and ethical guidelines. His expertise encompasses a range of therapeutic areas, facilitating collaborations between research institutions and healthcare providers. Through a patient-centered approach, Saldívar Cerón aims to contribute significantly to the development of effective treatments and therapeutic solutions in the clinical landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported