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Evaluation of Metabolic Functionality of Fruit and Vegetable Fermented Products in Adults

Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Age 18 to 65 years.

• Body mass index (BMI) ≥ 27 kg/m².

• Waist circumference \> 90 cm for men or \> 80 cm for women.

• Able and willing to provide written informed consent and comply with study procedures.

Locations
Other Locations
Taiwan
National Taiwan Sport University
RECRUITING
Taoyuan
Contact Information
Primary
Mon-Chien Lee, PhD
kurt0710@ntsu.edu.tw
+886-932388886
Backup
Chi-Chang Huang, PhD
john5523@ntsu.edu.tw
+886-930064498
Time Frame
Start Date: 2026-03-16
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 40
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: National Taiwan Sport University

This content was sourced from clinicaltrials.gov

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