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

April 17, 2026 updated by: Chi-Chang Huang, National Taiwan Sport University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Taiwan
      • Taoyuan District, Taiwan, 333325
        • Recruiting
        • National Taiwan Sport University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo Capsule
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.
Other: Placebo Capsule (Maltodextrin; GLUCIDEX®12)
One placebo capsule containing maltodextrin (GLUCIDEX®12) taken orally once daily at bedtime with water for 12 weeks.
Other Names:
  • Maltodextrin placebo capsule
  • GLUCIDEX®12
Experimental: Rutazyme® Lemon Fermented Product Capsule
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.
Dietary supplement: Rutazyme® Lemon Fermented Product Capsule
One capsule containing 500 mg Rutazyme® lemon fermented product taken orally once daily at bedtime with water for 12 weeks.
Other Names:
  • Rutazyme® lemon fermented product
  • Fruit and vegetable fermented product

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (Week 0) 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.
Baseline (Week 0) to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Waist Circumference
Time Frame: Baseline (Week 0) and Weeks 4, 8, and 12
Waist circumference (cm) will be measured with a measuring tape.
Baseline (Week 0) and Weeks 4, 8, and 12
Hip Circumference
Time Frame: Baseline (Week 0) and Weeks 4, 8, and 12
Hip circumference (cm) will be measured with a measuring tape.
Baseline (Week 0) and Weeks 4, 8, and 12
Fasting Glucose
Time Frame: Baseline (Week 0) and Week 12
Fasting glucose will be assessed from blood samples.
Baseline (Week 0) and Week 12
Fasting Insulin
Time Frame: Baseline (Week 0) and Week 12
Fasting insulin will be assessed from blood samples.
Baseline (Week 0) and Week 12
Inflammation Marker (hs-CRP)
Time Frame: Baseline (Week 0) and Week 12
High-sensitivity C-reactive protein (hs-CRP) will be assessed from blood samples.
Baseline (Week 0) and Week 12
GLP-1 Response After Capsule Intake
Time Frame: Baseline (Week 0) and Week 12
GLP-1 will be measured at 0, 30, 60, and 120 minutes after capsule intake.
Baseline (Week 0) and Week 12
PYY Response After Capsule Intake
Time Frame: Baseline (Week 0) and Week 12
PYY will be measured at 0, 30, 60, and 120 minutes after capsule intake.
Baseline (Week 0) and Week 12
Gut Microbiota Composition (Fecal Sample)
Time Frame: Baseline (Week 0) and Week 12
Gut microbiota composition will be assessed from fecal samples.
Baseline (Week 0) and Week 12
Fasting Triglycerides
Time Frame: Baseline (Week 0) and Week 12
Fasting triglycerides will be assessed from blood samples.
Baseline (Week 0) and Week 12
Fasting Total Cholesterol
Time Frame: Baseline (Week 0) and Week 12
Fasting total cholesterol will be assessed from blood samples.
Baseline (Week 0) and Week 12
Fasting LDL Cholesterol (LDL-C)
Time Frame: Baseline (Week 0) and Week 12
Fasting low-density lipoprotein cholesterol (LDL-C) will be assessed from blood samples.
Baseline (Week 0) and Week 12
Fasting HDL Cholesterol (HDL-C)
Time Frame: Baseline (Week 0) and Week 12
Fasting high-density lipoprotein cholesterol (HDL-C) will be assessed from blood samples.
Baseline (Week 0) and Week 12
Systolic Blood Pressure
Time Frame: Baseline (Week 0) and Weeks 4, 8, and 12
Systolic blood pressure (mmHg) will be measured using an automated blood pressure monitor (OMRON HEM-1000).
Baseline (Week 0) and Weeks 4, 8, and 12
Diastolic Blood Pressure
Time Frame: Baseline (Week 0) and Weeks 4, 8, and 12
Diastolic blood pressure (mmHg) will be measured using an automated blood pressure monitor (OMRON HEM-1000).
Baseline (Week 0) and Weeks 4, 8, and 12
Heart Rate
Time Frame: Baseline (Week 0) and Weeks 4, 8, and 12
Heart rate (beats per minute) will be measured using an automated blood pressure monitor (OMRON HEM-1000).
Baseline (Week 0) and Weeks 4, 8, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan Sport University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chi-Chang Huang, PhD, National Taiwan Sport University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NTSUIRB-114-106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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