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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

40

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

National Taiwan Sport University

Investigators

  • 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)

March 16, 2026

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

April 12, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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