Insulin SensitivityNCT07711587
Diaplex and Glycemic Control
A study testing Diaplex in people with Insulin Sensitivity and Healthy Adult, run by Standard Process Inc..
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity, Healthy Adult
- What is being tested?
- Diaplex
- 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 Sep 2026to 15 Dec 2027
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
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: A Pilot Study Investigating the Effects of Diaplex Supplementation on Glucose Regulation in Otherwise Healthy Adults With Elevated Blood Glucose Levels
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
Read the detailed description
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.
- Conditions
- Insulin Sensitivity, Healthy Adult
- Being tested
- Diaplex, Placebo
- Keywords
- Supplement, Chromium, Glycemic Index
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiaplexDietary supplement
Standard Process Diaplex product
PlaceboDietary supplement
Placebo with no chormium ingredients
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | No chromium ingredients Receives: Dietary Supplement: Placebo |
| Diaplex | Active comparator | Chromium ingredients Receives: Dietary Supplement: Diaplex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HOMA-IR
To determine whether 16 weeks of intervention with Diaplex improves insulin sensitivity versus placebo.
Measured: Baseline to 16-weeks
Secondary outcomes (6)
CGM (Weeks 15-16)
To characterize end-of-intervention glycemic patterns using CGM.
Measured: 2 weeks
Mean glucose
To characterize end-of-intervention glycemic patterns using CGM.
Measured: 2 weeks
Time-in-Range (70-180 mg/dL)
To characterize end-of-intervention glycemic patterns using CGM.
Measured: 2 weeks
Time Above/Below Range
To characterize end-of-intervention glycemic patterns using CGM.
Measured: 2 weeks
Coefficient of variation (CV)
To characterize end-of-intervention glycemic patterns using CGM.
Measured: 2 weeks
Post-prandial glucose Area Under the Curve
To characterize end-of-intervention glycemic patterns using CGM.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Insulin SensitivityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Standard Process Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shirin Pourafshar, PhD, Study director, Clinical Study Manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711587
- Sponsor's protocol ID
- SP028
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All participant data will be de-identified and saved
Publications
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.
PubMed 38938494Qu 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.
PubMed 21695082Trasino 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.
PubMed 25451926Mascolo 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.
PubMed 32456137Hua 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.
PubMed 22423897Hoffman 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.
PubMed 24725432Amer, 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).
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.
PubMed 32585827Yang 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.
PubMed 37960324
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Investigating the Effects of Diaplex Supplementation on Glucose Regulation in Otherwise Healthy Adults With Elevated Blood Glucose Levels
- ClinicalTrials.gov ID
- NCT07711587
- Acronym / sponsor ID
- SP028
- Conditions
- Insulin Sensitivity, Healthy Adult
- Keywords
- Supplement, Chromium, Glycemic Index
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Standard Process Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 17 Jul 2026 (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.
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
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboNo chromium ingredients |
| Diaplex | Active comparator | Dietary Supplement: DiaplexChromium ingredients |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| DiaplexStandard Process Diaplex product | Dietary supplement | Diaplex |
| PlaceboPlacebo with no chormium ingredients | Dietary supplement | Placebo |
Primary outcome
Changes in HOMA-IR
Time frame: Baseline to 16-weeks
To determine whether 16 weeks of intervention with Diaplex improves insulin sensitivity versus placebo.
6 secondary outcomes
CGM (Weeks 15-16)
Time frame: 2 weeks
Mean glucose
Time frame: 2 weeks
Time-in-Range (70-180 mg/dL)
Time frame: 2 weeks
Time Above/Below Range
Time frame: 2 weeks
Coefficient of variation (CV)
Time frame: 2 weeks
Post-prandial glucose Area Under the Curve
Time frame: 2 weeks
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 17 Jul 2026.
- Background: PubMed 38938494Wan 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.
- Background: PubMed 21695082Qu 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.
- Background: PubMed 25451926Trasino 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.
- Background: PubMed 32456137Mascolo 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.
- Background: PubMed 22423897Hua 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.
- Background: PubMed 24725432Hoffman 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.
- BackgroundAmer, 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).
- Background: PubMed 32585827Dubey 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.
- Background: PubMed 37960324Yang 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.
- Individual participant dataSharing planned: No. All participant data will be de-identified and saved
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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.
Shirin Pourafshar, PhD study director
Clinical Study Manager
Questions about this trial
What is this clinical trial studying?
A study testing Diaplex in people with Insulin Sensitivity and Healthy Adult, run by Standard Process Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 17 Jul 2026. 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 Chinmayee Panda, PhD (262-495-6410, cpanda@standardprocess.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in HOMA-IR (time frame: Baseline to 16-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07711587, which also lists 9 linked publications.
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 17 Jul 2026.