Type 2 Diabetes Mellitus
Conditions
Keywords
Glycemic Variability, Recently Diagnosed Diabetes, Nutrition Intervention, Continuous Glucose Monitoring, Metabolic Biomarkers, Gut Microbiota, Type 2 Diabetes Mellitus
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.
Interventions
DIETARY_SUPPLEMENTProtein-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_SUPPLEMENTPlacebo (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.
Sponsors
University of Illinois at Chicago
Héctor Iván Saldívar Cerón
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This is a quadruple-blind study. Participants, clinical staff, study investigators, and outcomes assessors will all be blinded to group allocation. Supplement and placebo sachets will be identical in appearance, taste, and packaging, and will be prepared by an external manufacturer (O'HERVANARIO).
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycemic Variability | Baseline, Week 4, Week 8, Week 12, and 4 weeks post-intervention (Week 16) | Change in Standard Deviation of Glucose Values (mg/dL) |
| Change in Coefficient of Variation of Glucose (%) | Baseline, Week 4, Week 8, Week 12, and Week 16 (4 weeks post-intervention) | The coefficient of variation (CV) of glucose levels will be calculated from CGM data to evaluate glycemic variability, reflecting the ratio between the SD and the mean glucose concentration during the monitoring period. |
| Change in Time in Range (TIR, % of time between 70-180 mg/dL) | Baseline, Week 4, Week 8, Week 12, and Week 16 (4 weeks post-intervention) | Time in Range (TIR) will be defined as the percentage of time that CGM glucose readings remain within the target range of 70-180 mg/dL. This measure will help assess overall glycemic control during and after the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gut Microbiota Composition | Baseline and Week 12 | Microbiota diversity and relative abundance will be assessed by 16S rRNA sequencing of stool samples. |
| Change in Skeletal Muscle Mass (kg) | Baseline and Week 12 | Skeletal muscle mass will be assessed via bioelectrical impedance analysis using the InBody H30. The difference in muscle mass from baseline to Week 12 will reflect changes in lean tissue due to the intervention. |
| Change in Visceral Fat Area (cm²) | Baseline and Week 12 | Visceral fat area will be calculated using the InBody H30 bioimpedance analyzer. The change in cm² from baseline to Week 12 will be used to evaluate the effect of the supplement on abdominal fat. |
| Change in Plasma Insulin Levels (μIU/mL) | Baseline and Week 12 | Plasma insulin concentrations will be measured using the Bio-Plex Pro Human Diabetes 10-Plex Assay. The change from baseline to Week 12 will help evaluate insulin sensitivity and pancreatic function. |
| Change in Hemoglobin A1c (HbA1c) | Baseline and Week 12 | Glycated hemoglobin (HbA1c) levels will be measured at baseline and post-intervention to assess long-term glycemic control. |
| Change in Plasma Leptin Levels (ng/mL) | Baseline and Week 12 | Leptin concentrations will be assessed in plasma using the Bio-Plex platform to evaluate changes in energy balance and adipose tissue signaling during the intervention. |
| Change in Plasma IL-6 Levels (pg/mL) | Baseline and Week 12 | Plasma levels of interleukin-6 (IL-6), a key inflammatory cytokine, will be measured to assess systemic inflammation. The change between baseline and Week 12 will be used as an indicator of intervention impact. |
| Change in Plasma TNF-α Levels (pg/mL) | Baseline and Week 12 | Plasma tumor necrosis factor alpha (TNF-α) will be quantified to evaluate pro-inflammatory status. The change from baseline to Week 12 will indicate potential anti-inflammatory effects of the intervention. |
| Change in Plasma Adiponectin Levels (μg/mL) | Baseline and Week 12 | Plasma adiponectin levels will be determined using a multiplex assay to assess anti-inflammatory and insulin-sensitizing effects. Changes from baseline to Week 12 will be compared between groups. |
| Change in Total Fat Mass (kg) | Baseline and Week 12 | Total fat mass will be measured by bioelectrical impedance analysis (BIA) using the InBody H30 device. The change in fat mass in kilograms will be evaluated from baseline to Week 12 to assess the effect of the intervention on body composition. |
| Change in Metabolic and Inflammatory Biomarkers | Baseline, Week 12 | Plasma levels of selected biomarkers (e.g., insulin, adiponectin, leptin, IL-6, TNF-α) will be measured using Bio-Plex Pro Human Diabetes 10-Plex Assay. |
Contacts
Primary ContactHector Ivan Saldivar Cerón, M.D., Ph.D.
Outcome results
None listed