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The goal of this 16-week double-blind, placebo-controlled pilot study is to determine whether daily Diaplex supplementation improves insulin sensitivity and glycemic control in adults with elevated blood glucose levels, while generating high-quality preliminary data on metabolic effects, glycemic patterns, and safety to inform future trials
This 16-week, double-blind, placebo-controlled pilot trial will evaluate whether daily supplementation with Standard Process Diaplex (three capsules per meal (nine capsules total), corresponding to a chromium dose of 250 mcg/day), improves insulin sensitivity and glycemic patterns in otherwise healthy adults with elevated blood glucose levels. The study combines robust fasting laboratory endpoints such as glucose, insulin, HOMA-IR, HbA1c, lipids, and ALT/AST, with a single high-quality continuous glucose monitoring (CGM) window during the final 10 -14 days, when chromium's cumulative metabolic effects are expected to be most detectable. Participants are carefully monitored throughout, with standardized tracking of diet, activity, and sleep to reduce variability, and the placebo-controlled design strengthens internal validity for detecting chromium's modest but clinically meaningful effects. This streamlined approach balances scientific precision with participant feasibility, producing high-value pilot data to guide a future definitive randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | No chromium ingredients |
|
| Diaplex | Active Comparator | Chromium ingredients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diaplex | Dietary Supplement | Standard Process Diaplex product |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in HOMA-IR | To determine whether 16 weeks of intervention with Diaplex improves insulin sensitivity versus placebo. | Baseline to 16-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| CGM (Weeks 15-16) | To characterize end-of-intervention glycemic patterns using CGM. | 2 weeks |
| Mean glucose | To characterize end-of-intervention glycemic patterns using CGM. |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting glucose | To evaluate changes in standard metabolic laboratory markers. | baseline to 16-weeks |
| Fasting insulin | To evaluate changes in standard metabolic laboratory markers. |
Inclusion Criteria • Adults 30-65 years old with elevated average blood glucose levels (100-125 mg/dL), confirmed at screening (HbA1c 5.7-6.4%)
• BMI 18.5-29.9 kg/m² (normal to overweight)
• Generally healthy individuals with no metabolic or endocrine disorders besides elevated blood glucose levels, meaning no metabolic syndrome, insulin resistance diagnosis, dyslipidemia diagnosis requiring treatment, thyroid disorders, etc.
• Stable weight for the past 3 months (±5%)
• Sedentary or lightly active baseline lifestyle (Light activity ≤3 times/week (e.g., walking, yoga, casual biking)
• Willingness to maintain usual diet, activity, and sleep patterns for 16 weeks
• Able and willing to wear a CGM for the final 10-14 days
• Willing to complete 3-day dietary recalls, sleep and activity logs
• Not taking or willing to stop taking supplements containing chromium, vitamin A, vitamin B6, iodine, and niacin
• Able and willing to provide informed consent and complete all study visits 6 Exclusion Criteria
• Any diagnosed metabolic/endocrine disorder, other than elevated blood glucose levels, such as metabolic syndrome, insulin resistance diagnosis, clinically significant dyslipidemia, thyroid dysfunction or use of thyroid medication, or obesity-related endocrine dysfunction
• Medications and supplements use of glucose-lowering medications within the past 3 months, including use of weight-loss drugs or metabolic agents, such asGLP-1 RAs (Ozempic, Wegovy, Rybelsus, Trulicity, Victoza, Saxenda) or GIP/GLP-1 RAas (Mounjaro, Zepbound)
• Use of supplements within the last 30 days containing chromium, vitamin A, vitamin B6, niacin, iodine
• Unwilling to discontinue prohibited supplements
• Health Conditions & safety such as elevated ALT/AST more than 2× the upper limit or known chronic liver disease or diagnosed renal impairment (eGFR <45 mL/min/1.73 m²), uncontrolled hypertension (>160/100 mmHg)
• Pregnant, breastfeeding, or planning pregnancy
• Allergy or sensitivity to study ingredients or CGM adhesives
• Lifestyle and compliance (>30 minutes/day of intense physical activity (active adults or athletes))
• Participation in another investigational trial in the past 30 days
• Any condition that may interfere with participation or data quality (per investigator guidance)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chinmayee Panda, PhD | Contact | 262-495-6410 | cpanda@standardprocess.com | |
| Brea Nance | Contact | 262-495-6410 | bnance@standardprocess.com |
| Name | Affiliation | Role |
|---|---|---|
| Shirin Pourafshar, PhD | Clinical Study Manager | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38938494 | Background | Wan S, He J, Simoes EJ, Mechanick JI, Wu WC, An P, Liu S. Chromium Supplementation to Reduce Cardiometabolic Risk Factors: A Novel Dose-Response Meta-Analysis of Randomized Clinical Trials. JACC Adv. 2023 Nov 23;2(10):100729. doi: 10.1016/j.jacadv.2023.100729. eCollection 2023 Dec. No abstract available. | |
| 21695082 | Background |
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All participant data will be de-identified and saved
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo |
| Dietary Supplement |
Placebo with no chormium ingredients |
|
| 2 weeks |
| Time-in-Range (70-180 mg/dL) | To characterize end-of-intervention glycemic patterns using CGM. | 2 weeks |
| Time Above/Below Range | To characterize end-of-intervention glycemic patterns using CGM. | 2 weeks |
| Coefficient of variation (CV) | To characterize end-of-intervention glycemic patterns using CGM. | 2 weeks |
| Post-prandial glucose Area Under the Curve | To characterize end-of-intervention glycemic patterns using CGM. | 2 weeks |
| baseline to 16-weeks |
| HbA1c | To evaluate changes in standard metabolic laboratory markers. | baseline to 16-weeks |
| Lipid profile | To evaluate changes in standard metabolic laboratory markers. | baseline to 16-weeks |
| Safety | To assess safety and tolerability in ALT and AST | baseline to 16-weeks |
| Adverse events | To assess safety and tolerability. | baseline to 16-weeks |
| Qu HQ, Li Q, Rentfro AR, Fisher-Hoch SP, McCormick JB. The definition of insulin resistance using HOMA-IR for Americans of Mexican descent using machine learning. PLoS One. 2011;6(6):e21041. doi: 10.1371/journal.pone.0021041. Epub 2011 Jun 14. |
| 25451926 | Background | Trasino SE, Benoit YD, Gudas LJ. Vitamin A deficiency causes hyperglycemia and loss of pancreatic beta-cell mass. J Biol Chem. 2015 Jan 16;290(3):1456-73. doi: 10.1074/jbc.M114.616763. Epub 2014 Dec 1. |
| 32456137 | Background | Mascolo E, Verni F. Vitamin B6 and Diabetes: Relationship and Molecular Mechanisms. Int J Mol Sci. 2020 May 23;21(10):3669. doi: 10.3390/ijms21103669. |
| 22423897 | Background | Hua Y, Clark S, Ren J, Sreejayan N. Molecular mechanisms of chromium in alleviating insulin resistance. J Nutr Biochem. 2012 Apr;23(4):313-9. doi: 10.1016/j.jnutbio.2011.11.001. |
| 24725432 | Background | Hoffman NJ, Penque BA, Habegger KM, Sealls W, Tackett L, Elmendorf JS. Chromium enhances insulin responsiveness via AMPK. J Nutr Biochem. 2014 May;25(5):565-72. doi: 10.1016/j.jnutbio.2014.01.007. Epub 2014 Feb 20. |
| Background | Amer, H.M., Mohamed, S.A., Elshafeey, F. et al. Health implications of prediabetes and the role of trace elements in insulin resistance. Futur J Pharm Sci 11, 59 (2025). |
| 32585827 | Background | Dubey P, Thakur V, Chattopadhyay M. Role of Minerals and Trace Elements in Diabetes and Insulin Resistance. Nutrients. 2020 Jun 23;12(6):1864. doi: 10.3390/nu12061864. |
| 37960324 | Background | Yang W, Jiang W, Guo S. Regulation of Macronutrients in Insulin Resistance and Glucose Homeostasis during Type 2 Diabetes Mellitus. Nutrients. 2023 Nov 4;15(21):4671. doi: 10.3390/nu15214671. |