Diaplex and Glycemic Control

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Пищевая добавка Diaplex
  Standard Process Diaplex product
• Пищевая добавка Placebo
  Placebo with no chormium ingredients

Первичные конечные точки

• Changes in HOMA-IR [Срок оценки: Baseline to 16-weeks]

Вторичные конечные точки (6)

• CGM (Weeks 15-16) [Срок оценки: 2 weeks]
• Mean glucose [Срок оценки: 2 weeks]
• Time-in-Range (70-180 mg/dL) [Срок оценки: 2 weeks]
• Time Above/Below Range [Срок оценки: 2 weeks]
• Coefficient of variation (CV) [Срок оценки: 2 weeks]
• Post-prandial glucose Area Under the Curve [Срок оценки: 2 weeks]

Критерии участия

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT07711587 · SP028

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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