Rutazyme Lemon Fermented Product Capsules for Metabolic Function in Adults With Obesity

Condition(s) studied

Investigational drug(s) / intervention(s)

Rutazyme® Lemon Fermented Product Capsule: One capsule containing 500 mg Rutazyme® lemon fermented product taken orally once daily at bedtime with water for 12 weeks.

Placebo Capsule (Maltodextrin; GLUCIDEX®12): One placebo capsule containing maltodextrin (GLUCIDEX®12) taken orally once daily at bedtime with water for 12 weeks.

Study summary

This study evaluates whether a fruit- and vegetable-based fermented product (Rutazyme® lemon fermented product) taken as a capsule can improve metabolic health in adults with obesity. Forty adults aged 18-65 years with obesity (BMI ≥ 27 kg/m² and waist circumference \> 90 cm for men or \> 80 cm for women) will be randomly assigned to receive either a Rutazyme® lemon fermented product capsule (500 mg) or a placebo capsule once daily at bedtime for 12 weeks. Before supplementation, participants will complete a 2-week stabilization period during which they maintain their usual diet and physical activity.

Body composition and waist/hip measurements will be assessed during the study, and blood pressure will be monitored. Blood samples will be collected to evaluate metabolic and safety laboratory measures (e.g., lipids, glucose, insulin, inflammation markers, liver and kidney function), and stool samples will be collected to assess gut microbiota. Gut-brain axis biomarkers (GLP-1 and PYY) will be measured at multiple time points after capsule intake at baseline and at Week 12. The results will help determine the metabolic effects and safety of Rutazyme® lemon fermented product supplementation in adults with obesity.

Eligibility

Primary outcome measure(s)

• Body Fat Percentage — Baseline (Week 0) to Week 12
  Body fat percentage (%) will be measured using bioelectrical impedance analysis (InBody 570). The primary endpoint is the change from baseline to Week 12.
• Fat Mass (kg) — Baseline (Week 0) to Week 12
  Fat mass will be measured using InBody 570. The endpoint is the change from baseline (Week 0) to Week 12.

Trial sites (1)

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