Rutazyme Lemon Fermented Product Capsules for Metabolic Function in Adults With Obesity
Evaluation of Metabolic Functionality of Fruit and Vegetable Fermented Products in Adults
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Mar 2026
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 16, 2026
CompletedFirst Submitted
Initial submission to the registry
April 12, 2026
CompletedFirst Posted
Study publicly available on registry
April 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
April 21, 2026
April 1, 2026
3 months
April 12, 2026
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Body Fat Percentage
Body fat percentage (%) will be measured using bioelectrical impedance analysis (InBody 570). The primary endpoint is the change from baseline to Week 12.
Baseline (Week 0) to Week 12
Fat Mass (kg)
Fat mass will be measured using InBody 570. The endpoint is the change from baseline (Week 0) to Week 12.
Baseline (Week 0) to Week 12
Secondary Outcomes (15)
Waist Circumference
Baseline (Week 0) and Weeks 4, 8, and 12
Hip Circumference
Baseline (Week 0) and Weeks 4, 8, and 12
Fasting Glucose
Baseline (Week 0) and Week 12
Fasting Insulin
Baseline (Week 0) and Week 12
Inflammation Marker (hs-CRP)
Baseline (Week 0) and Week 12
- +10 more secondary outcomes
Study Arms (2)
Placebo Capsule
PLACEBO COMPARATORParticipants 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.
Rutazyme® Lemon Fermented Product Capsule
EXPERIMENTALParticipants 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.
Interventions
One capsule containing 500 mg Rutazyme® lemon fermented product taken orally once daily at bedtime with water for 12 weeks.
One placebo capsule containing maltodextrin (GLUCIDEX®12) taken orally once daily at bedtime with water for 12 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan Sport University
Taoyuan District, 333325, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chi-Chang Huang, PhD
National Taiwan Sport University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Participants and investigators are blinded to treatment assignment. Rutazyme® and placebo capsules are identical in appearance and packaging.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 12, 2026
First Posted
April 21, 2026
Study Start
March 16, 2026
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share