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

Official title

Evaluation of Metabolic Functionality of Fruit and Vegetable Fermented Products in Adults

Overview

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.

Interventions

• 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 Placebo Capsule (Maltodextrin; GLUCIDEX®12)
  One placebo capsule containing maltodextrin (GLUCIDEX®12) taken orally once daily at bedtime with water for 12 weeks.

Primary outcome measures

• Body Fat Percentage [Time frame: Baseline (Week 0) to Week 12]
• Fat Mass (kg) [Time frame: Baseline (Week 0) to Week 12]

Secondary outcome measures (12)

• 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]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Taiwan · 1 center

• National Taiwan Sport University — Taoyuan

Identifiers

NCT: NCT07540949 · NTSUIRB-114-106

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗