Diaplex and Glycemic Control

NCT07711587 | Not Yet Recruiting

• 1 other identifier: SP028
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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 to inform future trials

Conditions

Insulin Sensitivity; Healthy Adult

Keywords

Supplement; Chromium; Glycemic Index

Outcome Measures

Primary Outcomes (1)

• Changes in HOMA-IR

  To determine whether 16 weeks of intervention with Diaplex improves insulin sensitivity versus placebo.

  Baseline to 16-weeks

Secondary Outcomes (6)

• CGM (Weeks 15-16)

  2 weeks

• Mean glucose

  2 weeks

• Time-in-Range (70-180 mg/dL)

  2 weeks

• Time Above/Below Range

  2 weeks

• Coefficient of variation (CV)

  2 weeks

Other Outcomes (6)

• Fasting glucose

  baseline to 16-weeks

• Fasting insulin

  baseline to 16-weeks

• HbA1c

  baseline to 16-weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

No chromium ingredients

Dietary Supplement: Placebo

Diaplex

ACTIVE COMPARATOR

Chromium ingredients

Dietary Supplement: Diaplex

Interventions

Diaplex DIETARY_SUPPLEMENT

Standard Process Diaplex product

Diaplex

Placebo DIETARY_SUPPLEMENT

Placebo with no chormium ingredients

Placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Standard Process Inc.: lead

Related Publications (9)

• 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.

  PMID: 38938494 BACKGROUND

• 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.

  PMID: 21695082 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.

  PMID: 25451926 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.

  PMID: 32456137 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.

  PMID: 22423897 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.

  PMID: 24725432 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).

  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.

  PMID: 32585827 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.

  PMID: 37960324 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Shirin Pourafshar, PhD

  Clinical Study Manager

  STUDY DIRECTOR

Central Study Contacts

Chinmayee Panda, PhD

CONTACT

262-495-6410; cpanda@standardprocess.com

Brea Nance

CONTACT

262-495-6410; bnance@standardprocess.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 17, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share