Clinical Research Directory

Whole-Food Magnesium for Mental and Cardiometabolic Health

This randomized, double-blind, placebo-controlled clinical trial will evaluate the effects of daily supplementation with E-Z Mg™, a commercially available whole-food-based magnesium supplement, on sleep, mood, fatigue, and cardiometabolic health in adults with elevated blood glucose. The study will enroll 45 adults aged 40-70 years with HbA1c 5.7%-6.4% and BMI 18.5-29.9 kg/m². Participants will be randomized to receive low-dose E-Z Mg™ providing 70 mg elemental magnesium per day, moderate-dose E-Z Mg™ providing 140 mg elemental magnesium per day, or placebo containing no magnesium for 12 weeks. All participants will also receive standardized nutrition education. The primary outcomes are changes in subjective and objective sleep quality, mood, and fatigue. These outcomes will be assessed using PROMIS questionnaires and actigraphy. Secondary outcomes include glycemic control, insulin sensitivity, continuous glucose monitoring-derived glucose measures, lipid profile, liver enzymes, inflammatory markers, blood pressure, anthropometric measures, body composition, dietary intake, and physical activity. Study assessments will occur at baseline, Week 6, and Week 12 and will include fasting blood samples, HbA1c testing (baseline and end of the stuy), continuous glucose monitoring, actigraphy, blood pressure, anthropometric and body composition measurements, dietary and physical activity assessments, demographics and medical and medication history questionnaires, adherence monitoring, and adverse-event monitoring. This study is designed to determine whether whole-food-based magnesium supplementation, and whether different doses of E-Z Mg™, may improve sleep, mood, fatigue, and cardiometabolic outcomes in adults with elevated blood glucose.

Understanding the Paradoxical Rise in Blood Glucose in the Context of a Low-carbohydrate Diet

The purpose of this project was to elucidate the phenomenon of elevated blood glucose in the context of dietary carbohydrate restriction. Accordingly, we sought to quantify glucagon, and related hormones, between individuals that are adhering to a low-carbohydrate diet that manifests with normal vs. elevated glucose. Moreover, we sought to test the dynamic effect of macronutrients on these same outcomes. Each participant completed 3 testing periods that included the consumption of a glucose drink, protein drink, or fat (olive oil) drink in a random order and separated by at least 2 days. Each drink was matched for volume and total calories and bloodwork was taken every 30 minutes to assess the outcomes of interest.

Effects of Zinc Supplementation on Patients With Elevated Glycemic Status

The goal of this randomized, double-blind, placebo-controlled study included patients with elevated glycemic status is to investigate whether zinc supplementation (4mg per day) has beneficial effects on controlling blood glucose.