ObesityPEDREDNCT07494253
Effects of Mulberry Leaf Extract Formulation on Postprandial Glycemic Levels in Obese Children and Adolescents
A study testing Reducose in people with Obesity, run by University of Bari Aldo Moro at 1 site in Italy.
Trial summary
The study entitled "Effects of mulberry leaf extract formulationon Postprandial Glycemic Peak in Obese Children and Adolescents: A Pilot Study" aims to evaluate the improvement in glycemic and insulinemic levels produced by a food supplement extracted from white mulberry (Morus alba), after 12 weeks of treatment in a… Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Obesity
- What is being tested?
- Reducose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Body mass index (BMI) >95° percentile for age and sex, according to WHO growth standards
- absence of chronic deseases
Who cannot join
- diagnosis of type 1 diabetes
- chronic use of steroid drugs
- known allergies or hypersensitvity to any component of the stusy product (Reducose)
- use of medications known to affect glucose metabolism
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Mulberry Leaf Extract Formulation on Postprandial Glycemic Levels in Obese Children and Adolescents: A Pilot Study (PEDRED)
The study entitled "Effects of mulberry leaf extract formulationon Postprandial Glycemic Peak in Obese Children and Adolescents: A Pilot Study" aims to evaluate the improvement in glycemic and insulinemic levels produced by a food supplement extracted from white mulberry (Morus alba), after 12 weeks of treatment in a cohort of obese children and adolescents.
Clinical and anthropometric data (age, sex, weight, height, BMI, pubertal stage) will be collected, along with data from blood chemistry tests performed during routine follow-up visits, in accordance with Good Clinical Practice guidelines.
Read the detailed description
At baseline (Time 0), participants undergo a comprehensive evaluation including medical history, physical examination, and anthropometric measurements. Blood tests are performed to assess liver enzymes, lipid profile, and glycated hemoglobin. Glucose metabolism is evaluated through an oral glucose tolerance test (OGTT) with repeated measurements of glucose, insulin, and C-peptide. Dietary habits and adherence to the Mediterranean diet are assessed using validated questionnaires, along with a 3-day food record. Gastrointestinal side effects and treatment adherence are also evaluated using standardized questionnaires.
Follow-up visits are scheduled at 4 weeks (T1) and 8 weeks (T2). At both time points, participants receive a physical examination and anthropometric assessment, and their dietary records, gastrointestinal symptoms, and treatment adherence are reviewed.
At 12 weeks (T3), a final evaluation is performed, including physical and anthropometric measurements, repeat blood tests, and a second OGTT. Dietary intake, gastrointestinal tolerability, and treatment adherence are reassessed to evaluate changes over the study period.
- Conditions
- Obesity
- Being tested
- Reducose, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReducoseDietary supplement
Reducose 250 mg oral sticks, administered twice daily, 1 at lunch and 1 at dinner, for 12 weeks
PlaceboOther
Participants will receive 2 placebo sticks per day, 1 at lunch and 1 at dinner, for 12 weeks. The placebo sticks will be indistinguishable from the active product and will contain inert excipients.
| Study group | Role | What they receive |
|---|---|---|
| mulberry leaf extract formulation | Experimental | Participants will receive 2 sticks of mulberry leaf extract formulation 250 mg per day, 1 at lunch and 1 at dinner, for 12 weeks. Receives: Dietary Supplement: Reducose |
| placebo | Placebo comparator | Participants will receive 2 placebo sticks per day, 1 at lunch and 1 at dinner, for 12 weeks. The placebo sticks will be indistinguishable from the active product and will contain inert excipients Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve for Plasma Glucose
Calculated from plasma glucose concentrations measured at 0, 30, 60, 90, and 120 minutes during the oral glucose tolerance test (OGTT).
Measured: Baseline and Week 12
Area under the curve (AUC) for plasma insulin
Calculated from plasma insulin concentrations measured at 0, 30, 60, 90, and 120 minutes during the oral glucose tolerance test (OGTT).
Measured: Baseline and Week 12
Maximum plasma glucose concentration (Gmax)
Maximum plasma glucose concentration observed during the oral glucose tolerance test (OGTT), based on samples collected at 0, 30, 60, 90, and 120 minutes.
Measured: Baseline and Week 12
Time to maximum plasma glucose concentration (Tmax)
Time required to reach the maximum plasma glucose concentration during the oral glucose tolerance test (OGTT), based on samples collected at 0, 30, 60, 90, and 120 minutes.
Measured: Baseline and Week 12
Glycated Hemoglobin
Change in glycated hemoglobin (HbA1c)
Measured: Change in glycated hemoglobin from baseline to Week 12, measured in fasting blood samples.
Homeostasis Model Assessment of Insulin Resistance
Change in HOMA-IR from baseline to Week 12, calculated from fasting plasma glucose and fasting plasma insulin values.
Measured: Baseline to Week 12
Secondary outcomes (4)
Change in body weight
Change in body weight measured during study visits as part of anthropometric assessment.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in body mass index (BMI)
Change in body mass index, calculated from body weight and height measured during study visits
Measured: baseline and week 12
Change in waist circumference
Change in waist circumference measured during study visits as part of anthropometric assessment
Measured: Baseline and week 12
Treatment adherence
Treatment adherence assessed using the 5-item Medication Adherence Report Scale (MARS-5). The score ranges from a minimum of 5 to a maximum of 25, where 25 indicates maximum adherence.
Measured: Baseline, Week 4, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Jun 2025
- Primary completion12 Jan 2026
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bari Aldo Moro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Felicia Faienza, University of Bari Aldo Moro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494253
- Sponsor's protocol ID
- 2078/CEL
- Acronym
- PEDRED
- Status last verified
- Jun 2026
- First submitted
- 12 Mar 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lown M, Fuller R, Lightowler H, Fraser A, Gallagher A, Stuart B, Byrne C, Lewith G. Mulberry-extract improves glucose tolerance and decreases insulin concentrations in normoglycaemic adults: Results of a randomised double-blind placebo-controlled study. PLoS One. 2017 Feb 22;12(2):e0172239. doi: 10.1371/journal.pone.0172239. eCollection 2017.
PubMed 28225835Lown M, Fuller R, Lightowler H, Fraser A, Gallagher A, Stuart B, Byrne CD, Lewith G. Mulberry extract to modULate Blood glucosE Responses in noRmoglYcaemic adults (MULBERRY): study protocol for a randomised controlled trial. Trials. 2015 Oct 28;16:486. doi: 10.1186/s13063-015-0997-2.
PubMed 26511964Li Y, Zhang X, Liang C, Hu J, Yu Z. Safety evaluation of mulberry leaf extract: Acute, subacute toxicity and genotoxicity studies. Regul Toxicol Pharmacol. 2018 Jun;95:220-226. doi: 10.1016/j.yrtph.2018.03.007. Epub 2018 Mar 9.
PubMed 29530616Marx TK, Glavits R, Endres JR, Palmer PA, Clewell AE, Murbach TS, Hirka G, Pasics I. A 28-Day Repeated Dose Toxicological Study of an Aqueous Extract of Morus Alba L. Int J Toxicol. 2016 Nov;35(6):683-691. doi: 10.1177/1091581816670597. Epub 2016 Oct 12.
PubMed 27733446Liu Y, Li X, Xie C, Luo X, Bao Y, Wu B, Hu Y, Zhong Z, Liu C, Li M. Prevention Effects and Possible Molecular Mechanism of Mulberry Leaf Extract and its Formulation on Rats with Insulin-Insensitivity. PLoS One. 2016 Apr 7;11(4):e0152728. doi: 10.1371/journal.pone.0152728. eCollection 2016.
PubMed 27054886Hjorne AP, Modvig IM, Holst JJ. The Sensory Mechanisms of Nutrient-Induced GLP-1 Secretion. Metabolites. 2022 May 7;12(5):420. doi: 10.3390/metabo12050420.
PubMed 35629924Hu TG, Wen P, Shen WZ, Liu F, Li Q, Li EN, Liao ST, Wu H, Zou YX. Effect of 1-Deoxynojirimycin Isolated from Mulberry Leaves on Glucose Metabolism and Gut Microbiota in a Streptozotocin-Induced Diabetic Mouse Model. J Nat Prod. 2019 Aug 23;82(8):2189-2200. doi: 10.1021/acs.jnatprod.9b00205. Epub 2019 Aug 8.
PubMed 31393724Bischoff H. Pharmacology of alpha-glucosidase inhibition. Eur J Clin Invest. 1994 Aug;24 Suppl 3:3-10.
PubMed 8001624Batiha GE, Al-Snafi AE, Thuwaini MM, Teibo JO, Shaheen HM, Akomolafe AP, Teibo TKA, Al-Kuraishy HM, Al-Garbeeb AI, Alexiou A, Papadakis M. Morus alba: a comprehensive phytochemical and pharmacological review. Naunyn Schmiedebergs Arch Pharmacol. 2023 Jul;396(7):1399-1413. doi: 10.1007/s00210-023-02434-4. Epub 2023 Mar 6.
PubMed 36877269Chan EW, Lye PY, Wong SK. Phytochemistry, pharmacology, and clinical trials of Morus alba. Chin J Nat Med. 2016 Jan;14(1):17-30. doi: 10.3724/SP.J.1009.2016.00017.
PubMed 26850343
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mulberry Leaf Extract Formulation on Postprandial Glycemic Levels in Obese Children and Adolescents: A Pilot Study (PEDRED)
- ClinicalTrials.gov ID
- NCT07494253
- Acronym / sponsor ID
- PEDRED / 2078/CEL
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Bari Aldo MoroUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 27 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.
The study entitled "Effects of mulberry leaf extract formulationon Postprandial Glycemic Peak in Obese Children and Adolescents: A Pilot Study" aims to evaluate the improvement in glycemic and insulinemic levels produced by a food supplement extracted from white mulberry (Morus alba), after 12 weeks of treatment in a cohort of obese children and adolescents.
Clinical and anthropometric data (age, sex, weight, height, BMI, pubertal stage) will be collected, along with data from blood chemistry tests performed during routine follow-up visits, in accordance with Good Clinical Practice guidelines.
Detailed description
At baseline (Time 0), participants undergo a comprehensive evaluation including medical history, physical examination, and anthropometric measurements. Blood tests are performed to assess liver enzymes, lipid profile, and glycated hemoglobin. Glucose metabolism is evaluated through an oral glucose tolerance test (OGTT) with repeated measurements of glucose, insulin, and C-peptide. Dietary habits and adherence to the Mediterranean diet are assessed using validated questionnaires, along with a 3-day food record. Gastrointestinal side effects and treatment adherence are also evaluated using standardized questionnaires.
Follow-up visits are scheduled at 4 weeks (T1) and 8 weeks (T2). At both time points, participants receive a physical examination and anthropometric assessment, and their dietary records, gastrointestinal symptoms, and treatment adherence are reviewed.
At 12 weeks (T3), a final evaluation is performed, including physical and anthropometric measurements, repeat blood tests, and a second OGTT. Dietary intake, gastrointestinal tolerability, and treatment adherence are reassessed to evaluate changes over the study period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mulberry leaf extract formulation | Experimental | Dietary Supplement: ReducoseParticipants will receive 2 sticks of mulberry leaf extract formulation 250 mg per day, 1 at lunch and 1 at dinner, for 12 weeks. |
| placebo | Placebo comparator | Other: PlaceboParticipants will receive 2 placebo sticks per day, 1 at lunch and 1 at dinner, for 12 weeks. The placebo sticks will be indistinguishable from the active product and will contain inert excipients |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Body mass index (BMI) >95° percentile for age and sex, according to WHO growth standards
- absence of chronic deseases
Key exclusion criteria (4 listed)
- diagnosis of type 1 diabetes
- chronic use of steroid drugs
- known allergies or hypersensitvity to any component of the stusy product (Reducose)
- use of medications known to affect glucose metabolism
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 |
|---|---|---|
| ReducoseReducose 250 mg oral sticks, administered twice daily, 1 at lunch and 1 at dinner, for 12 weeks | Dietary supplement | mulberry leaf extract formulation |
| PlaceboParticipants will receive 2 placebo sticks per day, 1 at lunch and 1 at dinner, for 12 weeks. The placebo sticks will be indistinguishable from the active product and will contain inert excipients. | Other | placebo |
Primary outcome
Area Under the Curve for Plasma Glucose
Time frame: Baseline and Week 12
Calculated from plasma glucose concentrations measured at 0, 30, 60, 90, and 120 minutes during the oral glucose tolerance test (OGTT).
Area under the curve (AUC) for plasma insulin
Time frame: Baseline and Week 12
Calculated from plasma insulin concentrations measured at 0, 30, 60, 90, and 120 minutes during the oral glucose tolerance test (OGTT).
Maximum plasma glucose concentration (Gmax)
Time frame: Baseline and Week 12
Maximum plasma glucose concentration observed during the oral glucose tolerance test (OGTT), based on samples collected at 0, 30, 60, 90, and 120 minutes.
Time to maximum plasma glucose concentration (Tmax)
Time frame: Baseline and Week 12
Time required to reach the maximum plasma glucose concentration during the oral glucose tolerance test (OGTT), based on samples collected at 0, 30, 60, 90, and 120 minutes.
Glycated Hemoglobin
Time frame: Change in glycated hemoglobin from baseline to Week 12, measured in fasting blood samples.
Change in glycated hemoglobin (HbA1c)
Homeostasis Model Assessment of Insulin Resistance
Time frame: Baseline to Week 12
Change in HOMA-IR from baseline to Week 12, calculated from fasting plasma glucose and fasting plasma insulin values.
4 secondary outcomes
Change in body weight
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in body mass index (BMI)
Time frame: baseline and week 12
Change in waist circumference
Time frame: Baseline and week 12
Treatment adherence
Time frame: Baseline, Week 4, Week 8, and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 28225835Lown M, Fuller R, Lightowler H, Fraser A, Gallagher A, Stuart B, Byrne C, Lewith G. Mulberry-extract improves glucose tolerance and decreases insulin concentrations in normoglycaemic adults: Results of a randomised double-blind placebo-controlled study. PLoS One. 2017 Feb 22;12(2):e0172239. doi: 10.1371/journal.pone.0172239. eCollection 2017.
- Background: PubMed 26511964Lown M, Fuller R, Lightowler H, Fraser A, Gallagher A, Stuart B, Byrne CD, Lewith G. Mulberry extract to modULate Blood glucosE Responses in noRmoglYcaemic adults (MULBERRY): study protocol for a randomised controlled trial. Trials. 2015 Oct 28;16:486. doi: 10.1186/s13063-015-0997-2.
- Background: PubMed 29530616Li Y, Zhang X, Liang C, Hu J, Yu Z. Safety evaluation of mulberry leaf extract: Acute, subacute toxicity and genotoxicity studies. Regul Toxicol Pharmacol. 2018 Jun;95:220-226. doi: 10.1016/j.yrtph.2018.03.007. Epub 2018 Mar 9.
- Background: PubMed 27733446Marx TK, Glavits R, Endres JR, Palmer PA, Clewell AE, Murbach TS, Hirka G, Pasics I. A 28-Day Repeated Dose Toxicological Study of an Aqueous Extract of Morus Alba L. Int J Toxicol. 2016 Nov;35(6):683-691. doi: 10.1177/1091581816670597. Epub 2016 Oct 12.
- Background: PubMed 27054886Liu Y, Li X, Xie C, Luo X, Bao Y, Wu B, Hu Y, Zhong Z, Liu C, Li M. Prevention Effects and Possible Molecular Mechanism of Mulberry Leaf Extract and its Formulation on Rats with Insulin-Insensitivity. PLoS One. 2016 Apr 7;11(4):e0152728. doi: 10.1371/journal.pone.0152728. eCollection 2016.
- Background: PubMed 35629924Hjorne AP, Modvig IM, Holst JJ. The Sensory Mechanisms of Nutrient-Induced GLP-1 Secretion. Metabolites. 2022 May 7;12(5):420. doi: 10.3390/metabo12050420.
- Background: PubMed 31393724Hu TG, Wen P, Shen WZ, Liu F, Li Q, Li EN, Liao ST, Wu H, Zou YX. Effect of 1-Deoxynojirimycin Isolated from Mulberry Leaves on Glucose Metabolism and Gut Microbiota in a Streptozotocin-Induced Diabetic Mouse Model. J Nat Prod. 2019 Aug 23;82(8):2189-2200. doi: 10.1021/acs.jnatprod.9b00205. Epub 2019 Aug 8.
- Background: PubMed 8001624Bischoff H. Pharmacology of alpha-glucosidase inhibition. Eur J Clin Invest. 1994 Aug;24 Suppl 3:3-10.
- Background: PubMed 36877269Batiha GE, Al-Snafi AE, Thuwaini MM, Teibo JO, Shaheen HM, Akomolafe AP, Teibo TKA, Al-Kuraishy HM, Al-Garbeeb AI, Alexiou A, Papadakis M. Morus alba: a comprehensive phytochemical and pharmacological review. Naunyn Schmiedebergs Arch Pharmacol. 2023 Jul;396(7):1399-1413. doi: 10.1007/s00210-023-02434-4. Epub 2023 Mar 6.
- Background: PubMed 26850343Chan EW, Lye PY, Wong SK. Phytochemistry, pharmacology, and clinical trials of Morus alba. Chin J Nat Med. 2016 Jan;14(1):17-30. doi: 10.3724/SP.J.1009.2016.00017.
- Individual participant dataSharing planned: Undecided
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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.
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 Reducose in people with Obesity, run by University of Bari Aldo Moro 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 4 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: enrolling by invitation, as of the sponsor's last update on 22 Jun 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?
This study is still under way. Results are not available in the source record yet.
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?
Area Under the Curve for Plasma Glucose (time frame: Baseline and Week 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07494253, which also lists 10 linked publications.
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 22 Jun 2026.