Weight ManagementNCT07451639
White Mulberry Leaf Extract for Metabolic Health in Overweight Adults Taking Metformin
A study testing Mulberry Leaf Extract in people with Weight Management, run by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Management
- What is being tested?
- Mulberry Leaf Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Metformin prescribed as part of routine clinical management for early metabolic abnormalities
- Stable glucose control for at least six months prior to enrolment
Who cannot join
- pregnancy or lactation
- severe infection
- advanced hepatic or renal insufficiency
- active malignancy
- any condition deemed incompatible with study participation.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliera Universitaria Pliclinico Paolo Giaccone
Palermo, 90127
About this study
Official title: 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.
Read more
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.
- Conditions
- Weight Management
- Being tested
- Mulberry Leaf Extract, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulberry Leaf ExtractDietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Intervention | Active comparator | Not described Receives: Dietary Supplement: Mulberry Leaf Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (11)
Change in Fasting Blood Glucose
Change from baseline in fasting blood glucose, measured in mg/dL, at 12 weeks. Unit of Measure: mg/dL
Measured: 12 weeks
Change in Total Cholesterol
Change from baseline in total cholesterol, measured in mg/dL, at 12 weeks. Unit of Measure: mg/dL
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 12 weeks
Glycated Hemoglobin (HbA1c)
Mean change from baseline in glycated hemoglobin, measured as percentage (%), at 12 weeks. Unit of Measure: %
Measured: 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.
Measured: 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
Measured: 12 weeks
Change in Triglycerides
Change from baseline in triglycerides, measured in mg/dL, at 12 weeks. Unit of Measure: mg/dL
Measured: 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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Mar 2023
- Primary completion1 Mar 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Citarrella, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451639
- Sponsor's protocol ID
- REMODEL
- Status last verified
- May 2026
- First submitted
- 19 Feb 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of White Mulberry Leaf Extract Supplementation on Metabolic Markers in Overweight Adults With Early Metabolic Dysregulation Receiving Metformin
- ClinicalTrials.gov ID
- NCT07451639
- Acronym / sponsor ID
- REMODEL
- Conditions
- Weight Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone PalermoUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Intervention | Active comparator | Dietary Supplement: Mulberry Leaf Extract |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Metformin prescribed as part of routine clinical management for early metabolic abnormalities
- Stable glucose control for at least six months prior to enrolment
Key exclusion criteria (5 listed)
- pregnancy or lactation
- severe infection
- advanced hepatic or renal insufficiency
- active malignancy
- any condition deemed incompatible with study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mulberry Leaf Extracthe 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 | Intervention |
| PlaceboPlacebo 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. | Dietary supplement | Placebo |
Primary outcome
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.
11 secondary outcomes
Change in Fasting Blood Glucose
Time frame: 12 weeks
Change in Total Cholesterol
Time frame: 12 weeks
Change in Fasting Plasma GLP-1
Time frame: 12 weeks
Change in Body Mass Index (BMI)
Time frame: 12 weeks
Change in Waist Circumference (WC)
Time frame: 12 weeks
Change in Waist-to-Height Ratio (WHtR)
Time frame: 12 weeks
Glycated Hemoglobin (HbA1c)
Time frame: 12 weeks
Change in High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: 12 weeks
Change in Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: 12 weeks
Change in Triglycerides
Time frame: 12 weeks
Impact of Weight on Self-Perceptions Questionnaire (IWSP) Total Score
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mulberry Leaf Extract in people with Weight Management, run by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (kg) from baseline to Week 12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.