NCT06920667Not yet recruiting
Effect of a Protein-Creatine-Omega3-Vitamin D Supplement on Glycemic Variability in Mexican Patients With Type 2 Diabetes
Effect of a Combined Whey Protein, Creatine, Omega-3, and Vitamin D Supplement on Glycemic Variability in Mexican Patients With Recently Diagnosed Type 2 Diabetes: A Randomized, Double-blind Trial Using Continuous Glucose Monitoring
Source: ClinicalTrials.gov · Last updated 13 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 1 Apr 2025
- Start date
- 1 Jun 2025
- Primary completion date
- 1 May 2026
- Lead sponsor
- Héctor Iván Saldívar Cerón
- Diseases
- Type 2 diabetes
- NCT number
- NCT06920667
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Jun 2025 to the primary completion date, 1 May 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of insulin or other antidiabetic medications beyond metformin
Other illness
- History of type 1 diabetes, pancreatitis, or major GI surgery
- Severe renal, hepatic, or cardiovascular disease
- Known allergy to supplement/placebo ingredients
- Any condition that, in the investigator's judgment, may interfere with study participation
Other
- Use of supplements with whey protein, creatine, omega-3, or vitamin D in the past 3 months
- Participation in another clinical trial within the past 3 months
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.