ObesityNCT07540949
Rutazyme Lemon Fermented Product Capsules for Metabolic Function in Adults With Obesity
A study testing Rutazyme® Lemon Fermented Product Capsule in people with Obesity and Metabolic Syndrome, run by National Taiwan Sport University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Metabolic Syndrome
- What is being tested?
- Rutazyme® Lemon Fermented Product Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Mar 2026to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan Sport University
Taoyuan, 333325
Chi-Chang Huang, PhD, +886-930064498, john5523@ntsu.edu.tw
About this study
Official title: Evaluation of Metabolic Functionality of Fruit and Vegetable Fermented Products in Adults
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.
Read the detailed description
This is a randomized, placebo-controlled, parallel-group study designed to assess the metabolic effects and safety of Rutazyme® lemon fermented product capsules in adults with obesity. A total of 40 participants (18-65 years) with simple obesity (BMI ≥ 27 kg/m²; waist circumference > 90 cm for men or > 80 cm for women) will be enrolled and randomly assigned in a 1:1 ratio to one of two arms: (A) placebo capsule or (B) Rutazyme® lemon fermented product capsule (500 mg). Participants will undergo a 2-week stabilization period prior to supplementation (Week -2 to Week 0) and will be instructed to maintain their usual diet and physical activity habits throughout the study. The intervention period lasts 12 weeks, during which participants will take one capsule orally once daily at bedtime with water.
Assessments are scheduled at Week -2 (stabilization), Week 0 (baseline), and Weeks 4, 8, and 12. Measures include body composition (InBody 570), waist and hip circumference, blood pressure and heart rate, and assessments of dietary intake and physical activity (including estimation of total daily energy expenditure). Safety and metabolic laboratory assessments include complete blood count; lipid profile (TG, TC, LDL-C, HDL-C); fasting glucose and insulin; inflammatory marker (hs-CRP); liver function (AST/GOT, ALT/GPT, γ-GT, albumin); and renal function (BUN, creatinine, uric acid). Stool samples will be collected at baseline and Week 12 for gut microbiota analysis.
To explore mechanistic gut-brain axis biomarkers, GLP-1 and PYY will be assessed at baseline and at Week 12 at multiple time points (0, 30, 60, and 120 minutes) following capsule intake. Blood samples will be collected by trained personnel, with procedures designed to minimize discomfort (e.g., use of an indwelling catheter during repeated time-point sampling). Laboratory analyses will be performed by qualified external laboratories.
- Conditions
- Obesity, Metabolic Syndrome
- Being tested
- Rutazyme® Lemon Fermented Product Capsule, Placebo Capsule (Maltodextrin; GLUCIDEX®12)
- Keywords
- fruit and vegetable fermented product, lemon fermented product, fermented food supplement, body fat, body composition, waist circumference, lipid profile, fasting glucose, insulin, inflammation, GLP-1, peptide YY, gut microbiota, gut-brain axis, placebo-controlled, randomized trial
- Medical subject headings
- Obesity, Metabolic Syndrome, Insulin Resistance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rutazyme® Lemon Fermented Product CapsuleDietary supplement
Also called Rutazyme® lemon fermented product, Fruit and vegetable fermented product
One capsule containing 500 mg Rutazyme® lemon fermented product taken orally once daily at bedtime with water for 12 weeks.
Placebo Capsule (Maltodextrin; GLUCIDEX®12)Other
Also called Maltodextrin placebo capsule, GLUCIDEX®12
One placebo capsule containing maltodextrin (GLUCIDEX®12) taken orally once daily at bedtime with water for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Capsule | Placebo comparator | Participants 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. Receives: Other: Placebo Capsule (Maltodextrin; GLUCIDEX®12) |
| Rutazyme® Lemon Fermented Product Capsule | Experimental | Participants 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. Receives: Dietary Supplement: Rutazyme® Lemon Fermented Product Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (Week 0) to Week 12
Secondary outcomes (15)
Waist Circumference
Waist circumference (cm) will be measured with a measuring tape.
Measured: Baseline (Week 0) and Weeks 4, 8, and 12
Hip Circumference
Hip circumference (cm) will be measured with a measuring tape.
Measured: Baseline (Week 0) and Weeks 4, 8, and 12
Fasting Glucose
Fasting glucose will be assessed from blood samples.
Measured: Baseline (Week 0) and Week 12
Fasting Insulin
Fasting insulin will be assessed from blood samples.
Measured: Baseline (Week 0) and Week 12
Inflammation Marker (hs-CRP)
High-sensitivity C-reactive protein (hs-CRP) will be assessed from blood samples.
Measured: Baseline (Week 0) and Week 12
GLP-1 Response After Capsule Intake
GLP-1 will be measured at 0, 30, 60, and 120 minutes after capsule intake.
Measured: Baseline (Week 0) and Week 12
PYY Response After Capsule Intake
PYY will be measured at 0, 30, 60, and 120 minutes after capsule intake.
Measured: Baseline (Week 0) and Week 12
Gut Microbiota Composition (Fecal Sample)
Gut microbiota composition will be assessed from fecal samples.
Measured: Baseline (Week 0) and Week 12
Fasting Triglycerides
Fasting triglycerides will be assessed from blood samples.
Measured: Baseline (Week 0) and Week 12
Fasting Total Cholesterol
Fasting total cholesterol will be assessed from blood samples.
Measured: Baseline (Week 0) and Week 12
Fasting LDL Cholesterol (LDL-C)
Fasting low-density lipoprotein cholesterol (LDL-C) will be assessed from blood samples.
Measured: Baseline (Week 0) and Week 12
Fasting HDL Cholesterol (HDL-C)
Fasting high-density lipoprotein cholesterol (HDL-C) will be assessed from blood samples.
Measured: Baseline (Week 0) and Week 12
Systolic Blood Pressure
Systolic blood pressure (mmHg) will be measured using an automated blood pressure monitor (OMRON HEM-1000).
Measured: Baseline (Week 0) and Weeks 4, 8, and 12
Diastolic Blood Pressure
Diastolic blood pressure (mmHg) will be measured using an automated blood pressure monitor (OMRON HEM-1000).
Measured: Baseline (Week 0) and Weeks 4, 8, and 12
Heart Rate
Heart rate (beats per minute) will be measured using an automated blood pressure monitor (OMRON HEM-1000).
Measured: Baseline (Week 0) and Weeks 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start16 Mar 2026
- Primary completion31 May 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to one of two parallel arms (Rutazyme® lemon fermented product capsule vs placebo capsule).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Chang Huang, National Taiwan Sport University
- Investigators
- Chi-Chang Huang, PhD, Principal investigator, National Taiwan Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540949
- Sponsor's protocol ID
- NTSUIRB-114-106
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Metabolic Functionality of Fruit and Vegetable Fermented Products in Adults
- ClinicalTrials.gov ID
- NCT07540949
- Acronym / sponsor ID
- NTSUIRB-114-106
- Conditions
- Obesity, Metabolic Syndrome
- Keywords
- fruit and vegetable fermented product, lemon fermented product, fermented food supplement, body fat, body composition, waist circumference, lipid profile, fasting glucose
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan Sport UniversityUniversity, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, placebo-controlled, parallel-group study designed to assess the metabolic effects and safety of Rutazyme® lemon fermented product capsules in adults with obesity. A total of 40 participants (18-65 years) with simple obesity (BMI ≥ 27 kg/m²; waist circumference > 90 cm for men or > 80 cm for women) will be enrolled and randomly assigned in a 1:1 ratio to one of two arms: (A) placebo capsule or (B) Rutazyme® lemon fermented product capsule (500 mg). Participants will undergo a 2-week stabilization period prior to supplementation (Week -2 to Week 0) and will be instructed to maintain their usual diet and physical activity habits throughout the study. The intervention period lasts 12 weeks, during which participants will take one capsule orally once daily at bedtime with water.
Assessments are scheduled at Week -2 (stabilization), Week 0 (baseline), and Weeks 4, 8, and 12. Measures include body composition (InBody 570), waist and hip circumference, blood pressure and heart rate, and assessments of dietary intake and physical activity (including estimation of total daily energy expenditure). Safety and metabolic laboratory assessments include complete blood count; lipid profile (TG, TC, LDL-C, HDL-C); fasting glucose and insulin; inflammatory marker (hs-CRP); liver function (AST/GOT, ALT/GPT, γ-GT, albumin); and renal function (BUN, creatinine, uric acid). Stool samples will be collected at baseline and Week 12 for gut microbiota analysis.
To explore mechanistic gut-brain axis biomarkers, GLP-1 and PYY will be assessed at baseline and at Week 12 at multiple time points (0, 30, 60, and 120 minutes) following capsule intake. Blood samples will be collected by trained personnel, with procedures designed to minimize discomfort (e.g., use of an indwelling catheter during repeated time-point sampling). Laboratory analyses will be performed by qualified external laboratories.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants are randomized to one of two parallel arms (Rutazyme® lemon fermented product capsule vs placebo capsule).
| Arm | Type | Receives |
|---|---|---|
| Placebo Capsule | Placebo comparator | Other: Placebo Capsule (Maltodextrin; GLUCIDEX®12)Participants 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 | Experimental | Dietary Supplement: Rutazyme® Lemon Fermented Product CapsuleParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rutazyme® Lemon Fermented Product CapsuleAlso: Rutazyme® lemon fermented product, Fruit and vegetable fermented productOne capsule containing 500 mg Rutazyme® lemon fermented product taken orally once daily at bedtime with water for 12 weeks. | Dietary supplement | Rutazyme® Lemon Fermented Product Capsule |
| Placebo Capsule (Maltodextrin; GLUCIDEX®12)Also: Maltodextrin placebo capsule, GLUCIDEX®12One placebo capsule containing maltodextrin (GLUCIDEX®12) taken orally once daily at bedtime with water for 12 weeks. | Other | Placebo Capsule |
Primary outcome
Body Fat Percentage
Time frame: Baseline (Week 0) to Week 12
Body fat percentage (%) will be measured using bioelectrical impedance analysis (InBody 570). The primary endpoint is the change from baseline to Week 12.
Fat Mass (kg)
Time frame: Baseline (Week 0) to Week 12
Fat mass will be measured using InBody 570. The endpoint is the change from baseline (Week 0) to Week 12.
15 secondary outcomes
Waist Circumference
Time frame: Baseline (Week 0) and Weeks 4, 8, and 12
Hip Circumference
Time frame: Baseline (Week 0) and Weeks 4, 8, and 12
Fasting Glucose
Time frame: Baseline (Week 0) and Week 12
Fasting Insulin
Time frame: Baseline (Week 0) and Week 12
Inflammation Marker (hs-CRP)
Time frame: Baseline (Week 0) and Week 12
GLP-1 Response After Capsule Intake
Time frame: Baseline (Week 0) and Week 12
PYY Response After Capsule Intake
Time frame: Baseline (Week 0) and Week 12
Gut Microbiota Composition (Fecal Sample)
Time frame: Baseline (Week 0) and Week 12
Fasting Triglycerides
Time frame: Baseline (Week 0) and Week 12
Fasting Total Cholesterol
Time frame: Baseline (Week 0) and Week 12
Fasting LDL Cholesterol (LDL-C)
Time frame: Baseline (Week 0) and Week 12
Fasting HDL Cholesterol (HDL-C)
Time frame: Baseline (Week 0) and Week 12
Systolic Blood Pressure
Time frame: Baseline (Week 0) and Weeks 4, 8, and 12
Diastolic Blood Pressure
Time frame: Baseline (Week 0) and Weeks 4, 8, and 12
Heart Rate
Time frame: Baseline (Week 0) and Weeks 4, 8, and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chi-Chang Huang, PhD principal investigator
National Taiwan Sport University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rutazyme® Lemon Fermented Product Capsule in people with Obesity and Metabolic Syndrome, run by National Taiwan Sport University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mon-Chien Lee, PhD (+886-932388886, kurt0710@ntsu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Fat Percentage (time frame: Baseline (Week 0) to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.