Weight Management
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTMulberry 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_SUPPLEMENTPlacebo
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.
Sponsors
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight (kg) from baseline to Week 12 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Blood Glucose | 12 weeks | Change from baseline in fasting blood glucose, measured in mg/dL, at 12 weeks. Unit of Measure: mg/dL |
| Change in Total Cholesterol | 12 weeks | Change from baseline in total cholesterol, measured in mg/dL, at 12 weeks. Unit of Measure: mg/dL |
| Change in Fasting Plasma GLP-1 | 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 |
| Change in Body Mass Index (BMI) | 12 weeks | BMI calculated as weight (kg) / height (m²). Report change from baseline to Week 12. Unit of Measure: kg/m² |
| Change in Waist Circumference (WC) | 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 |
| Change in Waist-to-Height Ratio (WHtR) | 12 weeks | WHtR calculated as waist circumference (cm) / height (cm). Report change from baseline to Week 12. Unit of Measure: ratio (unitless) |
| Glycated Hemoglobin (HbA1c) | 12 weeks | Mean change from baseline in glycated hemoglobin, measured as percentage (%), at 12 weeks. Unit of Measure: % |
| Change in High-Density Lipoprotein Cholesterol (HDL-C) | 12 weeks | Change from baseline in high-density lipoprotein cholesterol, measured in mg/dL, at 12 weeks. |
| Change in Low-Density Lipoprotein Cholesterol (LDL-C) | 12 weeks | Change from baseline in low-density lipoprotein cholesterol, measured in mg/dL, at 12 weeks.Unit of Measure: mg/dL |
| Change in Triglycerides | 12 weeks | Change from baseline in triglycerides, measured in mg/dL, at 12 weeks. Unit of Measure: mg/dL |
| Impact of Weight on Self-Perceptions Questionnaire (IWSP) Total Score | 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) |
Countries
Italy
Outcome results
None listed