Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07540949

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Metabolic Syndrome

Full registry 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.

Treatments and study arms

Rutazyme® Lemon Fermented Product Capsule

Dietary Supplement

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

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

Primary outcomes

Body Fat PercentageBaseline (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)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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

National Taiwan Sport University🇹🇼 Taoyuan, Taiwan

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Chi-Chang Huang, PhDContact

Email · Call +886-930064498