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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Change in Glycemic Variability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Glycemic Variability
时间窗: 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 (%)
时间窗: 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)
时间窗: 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.
次要结局
- Change in Plasma Adiponectin Levels (μg/mL)(Baseline and Week 12)
- Change in Plasma Leptin Levels (ng/mL)(Baseline and Week 12)
- Change in Plasma IL-6 Levels (pg/mL)(Baseline and Week 12)
- Change in Plasma TNF-α Levels (pg/mL)(Baseline and Week 12)
- Change in Total Fat Mass (kg)(Baseline and Week 12)
- Change in Metabolic and Inflammatory Biomarkers(Baseline, Week 12)
- Change in Gut Microbiota Composition(Baseline and Week 12)
- Change in Skeletal Muscle Mass (kg)(Baseline and Week 12)
- Change in Visceral Fat Area (cm²)(Baseline and Week 12)
- Change in Plasma Insulin Levels (μIU/mL)(Baseline and Week 12)
- Change in Hemoglobin A1c (HbA1c)(Baseline and Week 12)
研究者
Héctor Iván Saldívar Cerón
Principal Investigator
Universidad Nacional Autonoma de Mexico