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Not yet recruiting NCT07711587

Diaplex and Glycemic Control

No phase Interventional Insulin Sensitivity Healthy Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diaplex, Placebo.
Who it may be relevant to
Registry conditions: Insulin Sensitivity, Healthy Adult. Basic parameters: 30 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Pilot Study Investigating the Effects of Diaplex Supplementation on Glucose Regulation in Otherwise Healthy Adults With Elevated Blood Glucose Levels

Overview

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.

Interventions

  • Dietary supplement Diaplex
    Standard Process Diaplex product
  • Dietary supplement Placebo
    Placebo with no chormium ingredients

Primary outcome measures

  • Changes in HOMA-IR [Time frame: Baseline to 16-weeks]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 38938494
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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).
  • 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

Identifiers

NCT: NCT07711587 · SP028

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗