Type 2 Diabetes MellitusPROVID-DMNCT06920667
Effect of a Protein-Creatine-Omega3-Vitamin D Supplement on Glycemic Variability in Mexican Patients With Type 2 Diabetes
A study testing Protein-Creatine-Omega-3-Vitamin D Supplement in people with Type 2 Diabetes Mellitus, run by Héctor Iván Saldívar Cerón.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Protein-Creatine-Omega-3-Vitamin D Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 25 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the 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
- Being tested
- Protein-Creatine-Omega-3-Vitamin D Supplement, Placebo (Maltodextrin)
- Keywords
- Glycemic Variability, Recently Diagnosed Diabetes, Nutrition Intervention, Continuous Glucose Monitoring, Metabolic Biomarkers, Gut Microbiota, Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein-Creatine-Omega-3-Vitamin D SupplementDietary 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 (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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo (Maltodextrin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycemic Variability
Change in Standard Deviation of Glucose Values (mg/dL)
Measured: 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.
Measured: 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.
Measured: Baseline, Week 4, Week 8, Week 12, and Week 16 (4 weeks post-intervention)
Secondary outcomes (11)
Change in Hemoglobin A1c (HbA1c)
Glycated hemoglobin (HbA1c) levels will be measured at baseline and post-intervention to assess long-term glycemic control.
Measured: Baseline and Week 12
Change in Total Fat Mass (kg)
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.
Measured: Baseline and Week 12
Change in Metabolic and Inflammatory Biomarkers
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.
Measured: Baseline, Week 12
Change in Gut Microbiota Composition
Microbiota diversity and relative abundance will be assessed by 16S rRNA sequencing of stool samples.
Measured: Baseline and Week 12
Change in Skeletal Muscle Mass (kg)
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.
Measured: Baseline and Week 12
Change in Visceral Fat Area (cm²)
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.
Measured: Baseline and Week 12
Change in Plasma Insulin Levels (μIU/mL)
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.
Measured: Baseline and Week 12
Change in Plasma Adiponectin Levels (μg/mL)
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.
Measured: Baseline and Week 12
Change in Plasma Leptin Levels (ng/mL)
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.
Measured: Baseline and Week 12
Change in Plasma IL-6 Levels (pg/mL)
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.
Measured: Baseline and Week 12
Change in Plasma TNF-α Levels (pg/mL)
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.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion25 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Héctor Iván Saldívar Cerón
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago
- Responsible party
- Sponsor-investigator, Héctor Iván Saldívar Cerón, Universidad Nacional Autonoma de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920667
- Sponsor's protocol ID
- CE/FESI/032025/1908
- Other IDs
- FICDTEM-2023-131
- Acronym
- PROVID-DM
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) to be shared will include baseline and post-intervention values of glycemic variability (CGM metrics), HbA1c, fasting glucose, anthropometric data (body composition, grip strength), inflammatory and metabolic biomarkers, and gut microbiota profiles.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06920667
- Acronym / sponsor ID
- PROVID-DM / CE/FESI/032025/1908
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Glycemic Variability, Recently Diagnosed Diabetes, Nutrition Intervention, Continuous Glucose Monitoring, Metabolic Biomarkers, Gut Microbiota, Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Héctor Iván Saldívar CerónUniversity, hospital or other
- Collaborators
- University of Illinois Chicago
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 25 Oct 2026 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Supplement Group | Experimental | Dietary Supplement: Protein-Creatine-Omega-3-Vitamin D SupplementParticipants 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. |
| Placebo Group | Placebo comparator | Dietary Supplement: Placebo (Maltodextrin)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein-Creatine-Omega-3-Vitamin D SupplementParticipants 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. | Dietary supplement | Supplement Group |
| 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. | Dietary supplement | Placebo Group |
Primary outcome
Change in Glycemic Variability
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)
Change in Coefficient of Variation of Glucose (%)
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.
Change in Time in Range (TIR, % of time between 70-180 mg/dL)
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.
11 secondary outcomes
Change in Hemoglobin A1c (HbA1c)
Time frame: Baseline and Week 12
Change in Total Fat Mass (kg)
Time frame: Baseline and Week 12
Change in Metabolic and Inflammatory Biomarkers
Time frame: Baseline, Week 12
Change in Gut Microbiota Composition
Time frame: Baseline and Week 12
Change in Skeletal Muscle Mass (kg)
Time frame: Baseline and Week 12
Change in Visceral Fat Area (cm²)
Time frame: Baseline and Week 12
Change in Plasma Insulin Levels (μIU/mL)
Time frame: Baseline and Week 12
Change in Plasma Adiponectin Levels (μg/mL)
Time frame: Baseline and Week 12
Change in Plasma Leptin Levels (ng/mL)
Time frame: Baseline and Week 12
Change in Plasma IL-6 Levels (pg/mL)
Time frame: Baseline and Week 12
Change in Plasma TNF-α Levels (pg/mL)
Time frame: Baseline and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) to be shared will include baseline and post-intervention values of glycemic variability (CGM metrics), HbA1c, fasting glucose, anthropometric data (body composition, grip strength), inflammatory and metabolic biomarkers, and gut microbiota profiles.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Protein-Creatine-Omega-3-Vitamin D Supplement in people with Type 2 Diabetes Mellitus, run by Héctor Iván Saldívar Cerón.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hector Ivan Saldivar Cerón, M.D., Ph.D. (+525579801550, ivansaldi@iztacala.unam.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycemic Variability (time frame: Baseline, Week 4, Week 8, Week 12, and 4 weeks post-intervention (Week 16)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.