Effect of a Reducose®-Based Supplement on Metabolic Health in Subjects With Metabolic Syndrome

NCT07451639 | Completed

• 1 other identifier: REMODEL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change in Fasting Blood Glucose

  12 weeks

• Change in Total Cholesterol

  12 weeks

• Change in Fasting Plasma GLP-1

  12 weeks

• Change in Body Mass Index (BMI)

  12 weeks

• Change in Waist Circumference (WC)

  12 weeks

Other Outcomes (3)

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

  12 weeks

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

  12 weeks

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

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Intervention

ACTIVE COMPARATOR

Dietary Supplement: Mulberry Leaf Extract

Interventions

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.

Intervention

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Pliclinico Paolo Giaccone

Palermo, 90127, Italy

Location

MeSH Terms

Interventions

Morus alba

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 5, 2026
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)