Effects of Cornelian Cherry Supplementation in Patients With Metabolic Syndrome

Wroclaw Medical University55 enrolled

Overview

This randomized, double-blind, placebo-controlled, parallel-group study evaluated the effects of six-month oral supplementation with Cornus mas fruit lyophilizate in patients with metabolic syndrome. Participants were assigned to receive either 8 g of Cornus mas fruit lyophilizate once daily or a matching placebo. Ophthalmic assessments included best-corrected visual acuity, slit-lamp examination, dilated fundus examination, applanation tonometry, and Doppler ultrasonography of the ophthalmic, central retinal, and posterior ciliary arteries. Cardiometabolic and biochemical parameters were also assessed at baseline and after 3 and 6 months of supplementation.

This was a randomized, double-blind, placebo-controlled, parallel-group dietary intervention study conducted in patients with metabolic syndrome. Participants were randomly assigned to receive either 8 g of Cornus mas L. fruit lyophilizate once daily or a matching placebo for 6 months. The study aimed to evaluate the effects of Cornus mas supplementation on ophthalmic, vascular, cardiometabolic, and biochemical parameters. Ophthalmic examinations included best-corrected visual acuity for distance and near, slit-lamp biomicroscopy, dilated fundus examination, applanation tonometry, and Doppler ultrasonography of the ophthalmic artery, central retinal artery, and posterior ciliary artery. Cardiometabolic assessments included anthropometric measurements, 24-hour ambulatory blood pressure monitoring, oral glucose tolerance testing, insulin measurements, and serum lipid profile. Selected circulating biomarkers related to oxidative stress, inflammation, advanced glycation, and ocular physiology were also assessed. Study assessments were performed at baseline, after 3 months, and after 6 months of supplementation. In the second phase, the investigators will analyse samples of frozen blood and faeces previously collected from patients. The second phase will run from 1 August 2026 to 31 December 2026.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

Interventions

PlaceboDIETARY_SUPPLEMENT

A matching placebo formulation containing potato starch and sugar but no Cornus mas fruit lyophilizate, administered orally once daily for 6 months as a preparation made into a jelly.

Cornus mas Fruit LyophilizateDIETARY_SUPPLEMENT

A dietary supplement containing 8 g of lyophilized whole Cornus mas L. fruit, administered orally once daily for 6 months as a powder or granulate formulation prepared as a jelly.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 18 and 70 years * Metabolic syndrome defined as central obesity, with a waist circumference of ≥94 cm in men or ≥80 cm in women, and at least two of the following: * Fasting triglyceride concentration ≥1.7 mmol/L * Low high-density lipoprotein cholesterol concentration: \<1.03 mmol/L in men or \<1.29 mmol/L in women * Elevated blood pressure: systolic blood pressure ≥130 mmHg and diastolic blood pressure ≥85 mmHg * Fasting glucose concentration ≥6.5 mmol/L * Best-corrected visual acuity of 20/40 or better * Spherical refractive error between -4.0 and +4.0 diopters * Cylindrical refractive error between -3.0 and +3.0 diopters Exclusion Criteria: * Current smoking * Insulin-dependent diabetes mellitus * Liver disease * Gastrointestinal disease * Cancer * Inflammatory disease * Use of weight-loss medication * Use of anti-inflammatory medication * Pregnancy * Breastfeeding * Alcohol or drug abuse * Requirement to follow a medically prescribed diet other than the diet recommended for metabolic syndrome * Hypotension * Severe circulatory failure * Vascular endothelial abnormalities that could affect blood flow to the optic nerve head * Ocular surgery within 12 months before enrollment * Age-related macular degeneration * Diabetic retinopathy * Retinal vein occlusion * Glaucoma * Other serious acquired or hereditary ocular disease * Neurological disorder that could interfere with ophthalmological examinations

Locations (1)

Department of Pharmacology, Wroclaw Medical University

Wroclaw, Poland

Outcomes

Primary Outcomes

Red Blood Cell Count

Red blood cell count measured in peripheral venous blood using an automated hematology analyzer. Results will be reported as the mean red blood cell count for each study group.