Skip to main content
OpenTrials
Completed

NCT Number: NCT07451639

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Weight Management

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliera Universitaria Pliclinico Paolo Giaccone

Palermo, 90127, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mulberry Leaf Extract

Dietary Supplement

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.

Placebo

Dietary Supplement

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.

Primary outcomes

  1. Change in Body Weight (kg) from baseline to Week 12

    Time frame: 12 weeks

    Body weight measured in kilograms using a calibrated scale, under standardized conditions (e.g., light clothing, no shoes). Report change from baseline.

Secondary outcomes

  1. Change in Fasting Blood Glucose

    Time frame: 12 weeks

    Change from baseline in fasting blood glucose, measured in mg/dL, at 12 weeks. Unit of Measure: mg/dL

  2. Change in Total Cholesterol

    Time frame: 12 weeks

    Change from baseline in total cholesterol, measured in mg/dL, at 12 weeks. Unit of Measure: mg/dL

  3. Change in Fasting Plasma GLP-1

    Time frame: 12 weeks

    Change from baseline in fasting plasma glucagon-like peptide-1 (GLP-1), measured in pmol/L, at 12 weeks. Unit of Measure: pmol/L

  4. Change in Body Mass Index (BMI)

    Time frame: 12 weeks

    BMI calculated as weight (kg) / height (m²). Report change from baseline to Week 12. Unit of Measure: kg/m²

  5. Change in Waist Circumference (WC)

    Time frame: 12 weeks

    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

  6. Change in Waist-to-Height Ratio (WHtR)

    Time frame: 12 weeks

    WHtR calculated as waist circumference (cm) / height (cm). Report change from baseline to Week 12. Unit of Measure: ratio (unitless)

  7. Glycated Hemoglobin (HbA1c)

    Time frame: 12 weeks

    Mean change from baseline in glycated hemoglobin, measured as percentage (%), at 12 weeks. Unit of Measure: %

  8. Change in High-Density Lipoprotein Cholesterol (HDL-C)

    Time frame: 12 weeks

    Change from baseline in high-density lipoprotein cholesterol, measured in mg/dL, at 12 weeks.

  9. Change in Low-Density Lipoprotein Cholesterol (LDL-C)

    Time frame: 12 weeks

    Change from baseline in low-density lipoprotein cholesterol, measured in mg/dL, at 12 weeks.Unit of Measure: mg/dL

  10. Change in Triglycerides

    Time frame: 12 weeks

    Change from baseline in triglycerides, measured in mg/dL, at 12 weeks. Unit of Measure: mg/dL

  11. Impact of Weight on Self-Perceptions Questionnaire (IWSP) Total Score

    Time frame: 12 weeks

    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)

Other outcomes

  1. EuroQol 5-Dimension 5-Level (EQ-5D-5L) Level Sum Score

    Time frame: 12 weeks

    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)

  2. EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-VAS)

    Time frame: 12 weeks

    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)

  3. EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Value

    Time frame: 12 weeks

    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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 5, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.