Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07540949

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

Led by National Taiwan Sport University · Updated on 2026-04-21

40

Participants Needed

1

Research Sites

24 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 65 years
  • Body mass index (BMI) 27 kg/m8 or higher
  • Waist circumference greater than 90 cm for men or greater than 80 cm for women
  • Able and willing to provide written informed consent and comply with study procedures
Not Eligible

You will not qualify if you...

  • Pregnant, breastfeeding, or menopausal or postmenopausal
  • Use of enzyme supplements or fiber supplements within the past month
  • Current treatment with antihypertensive medications
  • Gastrointestinal disorders, including inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease)
  • Major cardiovascular, metabolic, or renal disease
  • Unable to provide informed consent or insufficient decision-making capacity
  • Investigator determines the participant is not suitable for the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Taiwan Sport University

Taoyuan, Taiwan, 333325

Actively Recruiting

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Research Team

M

Mon-Chien Lee, PhD

CONTACT

C

Chi-Chang Huang, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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