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

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Status: Completed

Conditions: Weight Management

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Mulberry Leaf Extract

Study type: Interventional

Funder types: Other

Identifiers

NCT07451639

REMODEL

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo

Intervention

Active Comparator group

Treatment:

Dietary Supplement: Mulberry Leaf Extract