Changeflow GovPing Healthcare & Life Sciences New Trial: Rutazyme Capsules, 40 Adults, Obesit...
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New Trial: Rutazyme Capsules, 40 Adults, Obesity, 12 Weeks

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Summary

A new clinical trial has been registered on ClinicalTrials.gov under identifier NCT07540949. The study will evaluate a lemon fermented product capsule (Rutazyme) for metabolic health in 40 adults aged 18-65 with obesity over 12 weeks. Participants will be randomised to receive either the active capsule or a placebo capsule daily.

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What changed

This entry registers a new clinical trial on ClinicalTrials.gov. The study is a randomised, placebo-controlled trial assessing a lemon fermented product capsule (Rutazyme) for improvements in metabolic health markers in adults with obesity. Forty participants will receive either the active capsule or placebo daily for 12 weeks, with metabolic and safety laboratory measures monitored throughout.

Sponsors, investigators, and institutional review boards should note the trial registration for coordination and compliance with ClinicalTrials.gov reporting requirements. No compliance deadline or penalty is stated in the registration entry.

Archived snapshot

Apr 22, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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

N/A NCT07540949 Kind: NA Apr 21, 2026

Abstract

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.

Conditions: Obesity, Metabolic Syndrome

Interventions: Rutazyme® Lemon Fermented Product Capsule, Placebo Capsule (Maltodextrin; GLUCIDEX®12)

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Last updated

Classification

Agency
NIH
Published
April 21st, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Clinical investigators Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical trial registration Metabolic health study Capsule supplementation
Threshold
BMI ≥ 27 kg/m²; waist circumference > 90 cm (men) or > 80 cm (women); 18-65 years of age
Geographic scope
United States US

Taxonomy

Primary area
Public Health
Operational domain
Regulatory Affairs
Topics
Pharmaceuticals Healthcare

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