Rutazyme Lemon Fermented Product Capsules for Metabolic Function in Adults With Obesity
Recruiting · NCT07540949 · Interventional (participants receive a specific treatment) · Lead sponsor: National Taiwan Sport University
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- National Taiwan Sport University - Taoyuan, Taiwan