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

Overview

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.

Interventions

• Dietary supplement Protein-Creatine-Omega-3-Vitamin D Supplement
  Participants will receive a daily powdered supplement containing 30 g of whey protein isolate, 5 g of creatine monohydrate, 1 g of omega-3 fatty acids (EPA/DHA), and 1,000 IU of vitamin D3. The supplement will be taken once daily for 12 weeks, dissolved in water. It is designed to reduce glycemic variability and improve metabolic parameters in individuals with recently diagnosed type 2 diabetes.
• Dietary supplement Placebo (Maltodextrin)
  Participants will receive a daily powdered placebo formulated with maltodextrin, without any active ingredients (no whey protein, creatine, omega-3, or vitamin D). It is identical in appearance, taste, and packaging to the active supplement. It will be taken once daily for 12 weeks and administered in the same conditions as the intervention group.

Primary outcome measures

• Change in Glycemic Variability [Time frame: Baseline, Week 4, Week 8, Week 12, and 4 weeks post-intervention (Week 16)]
• Change in Coefficient of Variation of Glucose (%) [Time frame: Baseline, Week 4, Week 8, Week 12, and Week 16 (4 weeks post-intervention)]
• Change in Time in Range (TIR, % of time between 70-180 mg/dL) [Time frame: Baseline, Week 4, Week 8, Week 12, and Week 16 (4 weeks post-intervention)]

Secondary outcome measures (11)

• Change in Hemoglobin A1c (HbA1c) [Time frame: Baseline and Week 12]
• Change in Total Fat Mass (kg) [Time frame: Baseline and Week 12]
• Change in Metabolic and Inflammatory Biomarkers [Time frame: Baseline, Week 12]
• Change in Gut Microbiota Composition [Time frame: Baseline and Week 12]
• Change in Skeletal Muscle Mass (kg) [Time frame: Baseline and Week 12]
• Change in Visceral Fat Area (cm²) [Time frame: Baseline and Week 12]
• Change in Plasma Insulin Levels (μIU/mL) [Time frame: Baseline and Week 12]
• Change in Plasma Adiponectin Levels (μg/mL) [Time frame: Baseline and Week 12]
• Change in Plasma Leptin Levels (ng/mL) [Time frame: Baseline and Week 12]
• Change in Plasma IL-6 Levels (pg/mL) [Time frame: Baseline and Week 12]
• Change in Plasma TNF-α Levels (pg/mL) [Time frame: Baseline and Week 12]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06920667 · CE/FESI/032025/1908 · FICDTEM-2023-131

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗