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

Sponsor
National Taiwan Sport University
Study ID
NCT07540949
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Rutazyme® Lemon Fermented Product Capsule — DIETARY_SUPPLEMENT
    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) — OTHER
    One placebo capsule containing maltodextrin (GLUCIDEX®12) taken orally once daily at bedtime with water for 12 weeks.

Study Details

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.

Key Dates

First listed
Apr 21, 2026
Start date
Mar 16, 2026
Status verified
Apr 2026
Primary completion
May 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo Capsule
    Participants will take one placebo capsule containing maltodextrin (GLUCIDEX®12) orally once daily at bedtime with water for 12 weeks, following a 2-week stabilization period during which usual diet and physical activity are maintained.
  • Experimental: Rutazyme® Lemon Fermented Product Capsule
    Participants will take one capsule containing 500 mg Rutazyme® lemon fermented product orally once daily at bedtime with water for 12 weeks, following a 2-week stabilization period during which usual diet and physical activity are maintained.

Primary Outcome Measure

Body Fat Percentage [ Time Frame: Baseline (Week 0) to Week 12 ]

Central Contacts

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