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COMPLETED
NCT07451639
NA

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

Sponsor: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

View on ClinicalTrials.gov

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.

Official title: Effect of White Mulberry Leaf Extract Supplementation on Metabolic Markers in Overweight Adults With Early Metabolic Dysregulation Receiving Metformin

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-03-01

Completion Date

2024-06-01

Last Updated

2026-05-27

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Mulberry Leaf Extract

he active supplement was Glicoper® (Pharmaluce S.r.l., Republic of San Marino\[PJ1\] ), containing Reducose® (Phynova Group Ltd, Oxford, UK), a proprietary aqueous extract of Morus alba L. leaves. Each capsule contained 250 mg of extract (12.5 mg DNJ). Participants assigned to the intervention group consumed one capsule before lunch and one before dinner, resulting in a total daily DNJ intake of 25 mg.

DIETARY_SUPPLEMENT

Placebo

Placebo capsules matched the active product in appearance, weight, and fill volume and contained microcrystalline cellulose. All capsules were manufactured under GMP conditions and supplied by Erbozeta S.p.A.

Locations (1)

Azienda Ospedaliera Universitaria Pliclinico Paolo Giaccone

Palermo, Italy