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

NCT07540949 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-21

No results posted yet for this 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.

Conditions

Interventions

DIETARY_SUPPLEMENT

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.

OTHER

Placebo Capsule (Maltodextrin; GLUCIDEX®12)

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

Sponsors & Collaborators

  • National Taiwan Sport University

    lead OTHER

Principal Investigators

  • Chi-Chang Huang, PhD · National Taiwan Sport University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-16
Primary Completion
2026-05-31
Completion
2026-08-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07540949 on ClinicalTrials.gov