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

NCT06920667 | Not Yet Recruiting

• 2 other identifiers: CE/FESI/032025/1908FICDTEM-2023-131
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Glycemic Variability; Recently Diagnosed Diabetes; Nutrition Intervention; Continuous Glucose Monitoring; Metabolic Biomarkers; Gut Microbiota; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Change in Glycemic Variability

  Change in Standard Deviation of Glucose Values (mg/dL)

  Baseline, Week 4, Week 8, Week 12, and 4 weeks post-intervention (Week 16)

• Change in Coefficient of Variation of Glucose (%)

  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.

  Baseline, Week 4, Week 8, Week 12, and Week 16 (4 weeks post-intervention)

• Change in Time in Range (TIR, % of time between 70-180 mg/dL)

  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.

  Baseline, Week 4, Week 8, Week 12, and Week 16 (4 weeks post-intervention)

Secondary Outcomes (11)

• Change in Hemoglobin A1c (HbA1c)

  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

Study Arms (2)

Supplement Group

EXPERIMENTAL

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.

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

Placebo Group

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo (Maltodextrin)

Interventions

Protein-Creatine-Omega-3-Vitamin D Supplement 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.

Supplement Group

Placebo (Maltodextrin) 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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Héctor Iván Saldívar Cerón: lead
• University of Illinois at Chicago: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

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

CONTACT

+525579801550; ivansaldi@iztacala.unam.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 10, 2025
• Study Start: June 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): October 25, 2026
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting information will be made available beginning 6 months after publication of the main results and will remain available for 5 years, or until depletion of data access capacity.
• Access Criteria: Access will be granted to qualified researchers affiliated with academic or health institutions, upon submission of a methodologically sound proposal. Requests will be reviewed by the principal investigator and ethics committee. Data will be shared through secure institutional platforms or upon direct contact with the research team.