Therapeutic Intervention of Eriomin Associated with Metformin in the Control of Hyperglycemia in Pre-Diabetic Patients

Summary

Citrus bioflavonoids, such as eriocitrin, hesperidin and naringin, have been shown improved hyperglycemia, insulin resistance and systemic inflammation, related to the development of type 2 diabetes. The nutraceutical Eriomin, a lemon flavonoid extract composed mainly by eriocitrin (70%) and other flavonoids (30%), improved the control of moderate hyperglycemia in pre-diabetic and diabetic patients without drug therapy. However, most patients with pre-diabetes are on oral biguanide (metformin) therapy, despite its limited efficacy (30-40%) on glycemic control and its undesirable gastrointestinal effects.

Therefore, in the current study, Eriomin will be administered at a dose of 250 mg/d to adults diagnosed with pre-diabetes and being treated with metformin (1,000 mg/d). This clinical trial was designed as a placebo-control, double-blind, two-arm, crossover design. Clinical characteristics, body composition, food consumption, metabolic and inflammatory biomarkers and the microbiota of all patients will be evaluated before, during and at the end of the 12-week period (arm). Biochemical and metabolic parameters associated with prediabetes are expected to improve or return to normal with Eriomin in combination with metformin. At the same time, an increase in beneficial intestinal bacteria is expected, reducing pre-diabetic dysbiosis, and perhaps a noticeable improvement in body composition.

Conditions

• Pre-diabetes

Interventions

DIETARY_SUPPLEMENT

Eriomin

Pre-diabetic patients on oral biguanide (metformin) (1000 mg/day) will receive a 250 mg/day capsule of Eriomin for 12 weeks.

DIETARY_SUPPLEMENT

Washout

After 12 weeks of treatment with the active component (Eriomin) or placebo, the participants will follow a washout for 2 weeks.

DIETARY_SUPPLEMENT

Placebo

Pre-diabetic patients on oral biguanide (metformin) (1000 mg/day) will receive a 250 mg/day placebo capsule for 12 weeks.

Sponsors & Collaborators

• Ingredients by Nature TM

  collaborator UNKNOWN

• Thais Cesar

  lead OTHER

Principal Investigators

• Thais B Cesar, PhD · São Paulo State University

• Maria Rita M De Oliveira, PhD · São Paulo State University

• Valeria Cristina Samdrim, PhD · São Paulo State University

• Katia Sivieri, PhD · São Paulo State University

• Adriana Lucia Mendes, PhD · São Paulo State University

• Gabriela A Meira, Nutrition · São Paulo State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

35 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-15

Primary Completion

2024-12-30

Completion

2024-12-30

Countries

• Brazil