Clinical trial NCT06920667: Effect of a Protein-Creatine-Omega3-Vitamin D Supplement on Glycemic Variability in Mexican Patients With Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Glycemic Variability
Recently Diagnosed Diabetes
Nutrition Intervention
Continuous Glucose Monitoring
Metabolic Biomarkers
Gut Microbiota
Type 2 Diabetes Mellitus
Lead sponsor: Universidad Nacional Autonoma de Mexico
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
First posted: 2025-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized 1:1 to either a multi-nutrient supplement group or a placebo group. Both arms will follow the same study procedures over a 12-week intervention period, with continuous glucose monitoring and clinical assessments at multiple time points.
Primary purpose: TREATMENT

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 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.

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 vitamin D-on glycemic variability in Mexican adults recently diagnosed with type 2 diabetes (diagnosis within the last 5 years, HbA1c 7.0-10.0%, treated with metformin or no pharmacologic therapy).

Forty participants will be randomized (1:1) to receive either the active supplement or placebo for 12 weeks. Glycemic variability will be assessed through five time points using continuous glucose monitoring (CGM) with FreeStyle Libre sensors. Secondary outcomes include changes in HbA1c, fasting glucose, anthropometric data (via InBody H30), metabolic and inflammatory biomarkers (Bio-Plex Pro Human Diabetes 10-Plex Assay), and gut microbiota composition (via 16S rRNA sequencing in collaboration with the University of Illinois at Chicago).

The study also includes biweekly clinical assessments to monitor adherence and safety, and a final post-intervention follow-up phase four weeks after supplementation ends. All participants will receive six months of free medical follow-up. The study is designed to explore the feasibility of using CGM and multi-nutrient supplementation as part of early, non-pharmacological strategies to improve glycemic control in Latin American populations.

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

Primary outcomes:
measure: Change in Glycemic Variability
timeFrame: Baseline, Week 4, Week 8, Week 12, and 4 weeks post-intervention (Week 16)
measure: Change in Coefficient of Variation of Glucose (%)
timeFrame: Baseline, Week 4, Week 8, Week 12, and Week 16 (4 weeks post-intervention)
measure: Change in Time in Range (TIR, % of time between 70-180 mg/dL)
timeFrame: Baseline, Week 4, Week 8, Week 12, and Week 16 (4 weeks post-intervention)
Secondary outcomes:
measure: Change in Hemoglobin A1c (HbA1c)
timeFrame: Baseline and Week 12
measure: Change in Total Fat Mass (kg)
timeFrame: Baseline and Week 12
measure: Change in Metabolic and Inflammatory Biomarkers
timeFrame: Baseline, Week 12
measure: Change in Gut Microbiota Composition
timeFrame: Baseline and Week 12
measure: Change in Skeletal Muscle Mass (kg)
timeFrame: Baseline and Week 12
measure: Change in Visceral Fat Area (cm²)
timeFrame: Baseline and Week 12
measure: Change in Plasma Insulin Levels (μIU/mL)
timeFrame: Baseline and Week 12
measure: Change in Plasma Adiponectin Levels (μg/mL)
timeFrame: Baseline and Week 12
measure: Change in Plasma Leptin Levels (ng/mL)
timeFrame: Baseline and Week 12
measure: Change in Plasma IL-6 Levels (pg/mL)
timeFrame: Baseline and Week 12
measure: Change in Plasma TNF-α Levels (pg/mL)
timeFrame: Baseline and Week 12
Other outcomes:
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