Clinical Trial

White Mulberry Leaf Extract for Metabolic Health in Overweight Adults Taking Metformin

Completed
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Summary
This study tests whether a mulberry leaf extract can help adults with early cardiometabolic risk lose more weight while taking metformin. People with cardiometabolic risk often have excess body weight, higher blood sugar, and changes in blood fats. Many take metformin to help control blood sugar. Researchers wanted to see if adding a mulberry leaf supplement could improve weight loss and support overall metabolic health. Adults could take part if they: * Were overweight (body mass index over 25) * Had early signs of metabolic risk * Had been taking metformin 1000 mg daily for at least six months The study lasted 12 weeks. Fifty adults took part. Participants were randomly assigned, like flipping a coin, to receive either: * Mulberry leaf extract (250 mg twice daily), or * A placebo, which looks the same but contains no active ingredient Participants took the capsules 10 minutes before lunch and dinner. They continued their usual diet and physical activity. Researchers contacted participants each month to check capsule use and monitor safety. The main goal was to measure changes in: * Body weight * Body mass index * Waist size Researchers also measured blood sugar, cholesterol, liver health, and quality of life. The study aimed to find out whether adding mulberry leaf extract to stable metformin treatment could lead to greater weight loss and support metabolic health compared to placebo.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-03-02.
Trial Details
NCT Number NCT07451639
Lead Sponsor Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Conditions Weight Management
Enrollment 50 participants
Start Date 2023-03-01
Primary Completion 2024-03-01 (estimated)
Study Completion 2024-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-27