The Impact of a Daily Dietary Supplement on Glycemic Control in Individuals With Overweight or Obesity

Participants will enroll in this randomized, double-blind, placebo-controlled, parallel-group trial in which they will consume the assigned intervention daily, 15 minutes before their largest meal. Continuous glucose monitoring will be used to characterize glucose responses under real-world conditions. Repeated blood draws will quantify changes in metabolic hormones and inflammatory biomarkers during three distinct standardized meal tests. These tests will take place at baseline, 45 days, and 90 days of supplementation. DEXA scans and anthropometric measurements, such as waist circumfrance, will assess body composition changes. Dietary recalls will be collected to evaluate behavioral changes and dietary adherence. Activity monitors will be used to assess physical activity and sleep patterns.

Assessments:

Visit 1 (Baseline) - morning visit

• Informed consent
• DEXA scan (fasted)
• Waist and hip circumference
• Placement of CGM #1

Visit 2 (Day 2) - morning visit

• Fasted Standardized meal test
• Pre-test blood draw, 30 minutes post blood draw, 1 hour post blood draw
• During the resting/waiting period:
• Give activity tracker and orient to dietary tracking. Ensure CGM functionality.

Visit 3 (Day 15)

• Check symptoms and adverse events
• Replace glucose monitor
• Dietary tracking and physical activity education

Visit 4 (Day 30)

• Check symptoms and adverse events
• Replace glucose monitor
• Dietary tracking and physical activity education

Visit 5 (Day 45- halfway point)

• Fasted standardized meal and blood draws
• Check symptoms and adverse events
• Replace glucose monitor
• Dietary tracking and physical activity education

Visit 6 (Day 60)

• Check symptoms and adverse events
• Replace glucose monitor
• Dietary tracking and physical activity education

Visit 7 (Day 75)

• Check symptoms and adverse events
• Replace glucose monitor
• Dietary tracking and physical activity education

Visit 8 (Day 90)

• Fasted standardized meal and blood draws
• Waist and hip circumference measurements
• DEXA scan
• Collect equipment and supplies back from participant

Visit 9 (Day 91)

• CGM removal (Full 24 hr after intervention)

STATISTICAL ANALYSIS PLAN

Primary Outcome:

Change in acute fasted glucose AUC at baseline, Day 45 and Day 90.

Primary Analysis:

Mixed-effects linear model with:

• Fixed effects: group, time, group × time
• Random effect: participant

Secondary Analyses:

• Repeated-measures mixed models for hormones
• Repeated-measures mixed models for body composition
• ANCOVA models controlling for baseline values
• Sensitivity analyses for dietary intake and adherence
• Physical Activity data as a covariate with glucose data

Power Analysis:

Assuming an effect size of d=0.60, alpha=0.05, and 80% power, 52 participants are required. Enrollment of 60 participants allows for approximately 15% attrition.