Rutazyme lemon fermented capsules for metabolic health in adults with obesity
Evaluation of Metabolic Functionality of Fruit and Vegetable Fermented Products in Adults
This will test whether taking a Rutazyme lemon fermented capsule each night can help improve metabolic health in adults with obesity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | National Taiwan Sport University Academic / other |
| Locations | 1 site (Taoyuan) |
| Trial ID | NCT07540949 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled trial will enroll 40 adults aged 18–65 with obesity to receive either a 500 mg Rutazyme lemon fermented product capsule or a placebo daily at bedtime for 12 weeks after a 2-week stabilization period. Participants will be randomized 1:1 and asked to maintain their usual diet and activity levels during the study. Outcomes include body composition and waist/hip measurements, blood pressure, metabolic blood tests (lipids, glucose, insulin, liver and kidney function, hs-CRP), stool microbiota analysis, and gut-brain hormones such as GLP-1 and PYY. Assessments occur at baseline and at Weeks 4, 8, and 12 to monitor safety and metabolic changes.
Who should consider this trial
Good fit: Adults 18–65 years with BMI ≥ 27 kg/m² and waist circumference >90 cm for men or >80 cm for women who can give informed consent and attend study visits are ideal candidates.
Not a fit: People who are pregnant, breastfeeding, menopausal/postmenopausal, have major cardiovascular, renal, or gastrointestinal disease, are taking antihypertensive medications, or recently used enzyme or fiber supplements may not benefit or be eligible.
Why it matters
Potential benefit: If effective, the supplement could help reduce body fat and improve metabolic markers such as blood lipids and glucose control.
How similar studies have performed: Some small studies of fermented or plant-based supplements have shown modest metabolic benefits, but high-quality evidence is limited and this specific product is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Taoyuan
- National Taiwan Sport University — Taoyuan, Taiwan (Recruiting)
Study contacts
- Principal investigator: Chi-Chang Huang, PhD — National Taiwan Sport University
- Study coordinator: Mon-Chien Lee, PhD
- Email: kurt0710@ntsu.edu.tw
- Phone: +886-932388886
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.