A Pilot Study Investigating the Effects of Diaplex Supplementation on Glucose Regulation in Otherwise Healthy Adults With Elevated Blood Glucose Levels
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Changes in HOMA-IR
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Changes in HOMA-IR
时间窗: Baseline to 16-weeks
To determine whether 16 weeks of intervention with Diaplex improves insulin sensitivity versus placebo.
次要结局
- 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)
- Post-prandial glucose Area Under the Curve(2 weeks)