Healthy Adult, Insulin Sensitivity
Conditions
Keywords
Supplement, Chromium, Glycemic Index
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
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_SUPPLEMENTDiaplex
Standard Process Diaplex product
DIETARY_SUPPLEMENTPlacebo
Placebo with no chormium ingredients
Sponsors
Standard Process Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in HOMA-IR | Baseline to 16-weeks | To determine whether 16 weeks of intervention with Diaplex improves insulin sensitivity versus placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CGM (Weeks 15-16) | 2 weeks | To characterize end-of-intervention glycemic patterns using CGM. |
| Mean glucose | 2 weeks | To characterize end-of-intervention glycemic patterns using CGM. |
| Time-in-Range (70-180 mg/dL) | 2 weeks | To characterize end-of-intervention glycemic patterns using CGM. |
| Time Above/Below Range | 2 weeks | To characterize end-of-intervention glycemic patterns using CGM. |
| Coefficient of variation (CV) | 2 weeks | To characterize end-of-intervention glycemic patterns using CGM. |
| Post-prandial glucose Area Under the Curve | 2 weeks | To characterize end-of-intervention glycemic patterns using CGM. |
Contacts
CONTACTChinmayee Panda, PhD
CONTACTBrea Nance
STUDY_DIRECTORShirin Pourafshar, PhD
Clinical Study Manager
Outcome results
None listed