NCT Number: NCT06920667
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline, Week 4, Week 8, Week 12, and 4 weeks post-intervention (Week 16)
Change in Standard Deviation of Glucose Values (mg/dL)
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 12
Glycated hemoglobin (HbA1c) levels will be measured at baseline and post-intervention to assess long-term glycemic control.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 12
Microbiota diversity and relative abundance will be assessed by 16S rRNA sequencing of stool samples.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Héctor Iván Saldívar Cerón
Other
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
Acronym: PROVID-DM
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