Effect of a Protein-Creatine-Omega3-Vitamin D Supplement on Glycemic Variability in Mexican Patients With Type 2 Diabetes (PROVID-DM)

Héctor Iván Saldívar Cerón

Status: Begins enrollment in 1 month

Conditions: Type 2 Diabetes Mellitus

Treatments: Dietary Supplement: Protein-Creatine-Omega-3-Vitamin D Supplement; Dietary Supplement: Placebo (Maltodextrin)

Study type: Interventional

Funder types: Other

Identifiers

NCT06920667

CE/FESI/032025/1908

FICDTEM-2023-131 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Supplement Group

Experimental group

Description:

Participants assigned to this arm will receive a daily nutritional supplement for 12 weeks. The supplement will be provided in powdered sachets 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. Participants will dissolve the sachet in water and consume it once daily. Glycemic variability will be assessed through continuous glucose monitoring at five time points, and clinical evaluations will be performed biweekly.

Treatment:

Dietary Supplement: Protein-Creatine-Omega-3-Vitamin D Supplement

Placebo Group

Placebo Comparator group

Description:

Participants in this arm will receive a daily placebo for 12 weeks. The placebo will be formulated with maltodextrin and will be identical in appearance, taste, and packaging to the active supplement. It will not contain whey protein, creatine, omega-3, or vitamin D. Participants will dissolve the sachet in water and consume it once daily. Glycemic variability and all other outcome measures will be assessed in the same schedule and manner as in the intervention group.

Treatment:

Dietary Supplement: Placebo (Maltodextrin)