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

NCT ID: NCT06920667

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-10-25

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Supplement Group

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.

Group Type: EXPERIMENTAL

Protein-Creatine-Omega-3-Vitamin D Supplement

Intervention Type: DIETARY_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.

Placebo Group

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.

Group Type: PLACEBO_COMPARATOR

Placebo (Maltodextrin)

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: collaborator

Héctor Iván Saldívar Cerón

OTHER

Sponsor Role: lead

Responsible Party

Héctor Iván Saldívar Cerón

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Hector Ivan Saldivar Cerón, M.D., Ph.D.

Role: CONTACT

ivansaldi@iztacala.unam.mx

+525579801550

Other Identifiers

FICDTEM-2023-131

Identifier Type: OTHER

Identifier Source: secondary_id

CE/FESI/032025/1908

Identifier Type: -

Identifier Source: org_study_id