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

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

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.

Study Overview

• Status: Completed
• Conditions: Weight Management
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Mulberry Leaf Extract

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Palermo, Italy, 90127
    • Azienda Ospedaliera Universitaria Pliclinico Paolo Giaccone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Metformin prescribed as part of routine clinical management for early metabolic abnormalities
• Stable glucose control for at least six months prior to enrolment

Exclusion Criteria:

• pregnancy or lactation
• severe infection
• advanced hepatic or renal insufficiency
• active malignancy
• any condition deemed incompatible with study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	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.
Active Comparator: Intervention	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Weight (kg) from baseline to Week 12	Body weight measured in kilograms using a calibrated scale, under standardized conditions (e.g., light clothing, no shoes). Report change from baseline.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fasting Blood Glucose	Change from baseline in fasting blood glucose, measured in mg/dL, at 12 weeks. Unit of Measure: mg/dL	12 weeks
Change in Total Cholesterol	Change from baseline in total cholesterol, measured in mg/dL, at 12 weeks. Unit of Measure: mg/dL	12 weeks
Change in Fasting Plasma GLP-1	Change from baseline in fasting plasma glucagon-like peptide-1 (GLP-1), measured in pmol/L, at 12 weeks. Unit of Measure: pmol/L	12 weeks
Change in Body Mass Index (BMI)	BMI calculated as weight (kg) / height (m²). Report change from baseline to Week 12. Unit of Measure: kg/m²	12 weeks
Change in Waist Circumference (WC)	Waist circumference measured in centimeters (cm) using a non-stretch tape at a standardized anatomical site (e.g., midpoint between the lowest rib and iliac crest). Report change from baseline to Week 12. Unit of Measure: cm	12 weeks
Change in Waist-to-Height Ratio (WHtR)	WHtR calculated as waist circumference (cm) / height (cm). Report change from baseline to Week 12. Unit of Measure: ratio (unitless)	12 weeks
Glycated Hemoglobin (HbA1c)	Mean change from baseline in glycated hemoglobin, measured as percentage (%), at 12 weeks. Unit of Measure: %	12 weeks
Change in High-Density Lipoprotein Cholesterol (HDL-C)	Change from baseline in high-density lipoprotein cholesterol, measured in mg/dL, at 12 weeks.	12 weeks
Change in Low-Density Lipoprotein Cholesterol (LDL-C)	Change from baseline in low-density lipoprotein cholesterol, measured in mg/dL, at 12 weeks.Unit of Measure: mg/dL	12 weeks
Change in Triglycerides	Change from baseline in triglycerides, measured in mg/dL, at 12 weeks. Unit of Measure: mg/dL	12 weeks
Impact of Weight on Self-Perceptions Questionnaire (IWSP) Total Score	Change from baseline in the Impact of Weight on Self-Perception (IWSP) total score, calculated as the sum of three items rated on a 1-5 Likert scale (total score range 3-15; higher scores indicate greater perceived impact of body weight on self-image), at 12 weeks. Units on a scale (3-15)	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Level Sum Score	Change from baseline in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Level Sum Score, calculated as the sum of the five dimension levels (range 5-25; higher scores indicate poorer health), at 12 weeks. Units on a scale (5-25)	12 weeks
EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-VAS)	Change from baseline in self-rated health assessed by the EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-VAS; range 0-100, higher scores indicate better health), at 12 weeks. Units on a scale (0-100)	12 weeks
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Value	Change from baseline in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) index value (utility), derived using the Italian EQ-5D-5L national valuation set, at 12 weeks. Utility units: index value	12 weeks

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Morus alba
• Other Study ID Numbers: REMODEL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No