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.
Inclusion Criteria:
aged between 18 and 70 years, with diagnosed metabolic syndrome (central obesity with a waist circumference of ≥ 94 cm in men and ≥ 80 cm in women) and at least 2 of the following criteria: elevated fasting triglyceride levels of ≥ 1.7 mmol/l, low HDL cholesterol (<1.03 mmol/l in men and >1.29 mmol/l in women), elevated blood pressure (systolic ≥130 mmHg and diastolic ≥85 mmHg), and fasting glucose level ≥6.5 mmol/l. The ophthalmological inclusion criteria for patients were as follows: best-corrected visual acuity ≥ 20/40, spherical refraction between -4 and +4 dioptres, and cylindrical correction within the range of ± 3.0 dioptres.
Exclusion Criteria:
smoking, insulin-dependent diabetes, liver or gastrointestinal diseases, cancer, inflammatory diseases, taking weight-loss or anti-inflammatory medication, pregnancy, breastfeeding, alcohol or drug abuse, the need to follow a medically prescribed diet (other than the diet recommended for metabolic syndrome) . Patients with hypotension, severe circulatory failure or other abnormalities of the vascular endothelium that could affect blood flow to the optic nerve head were also excluded from the study. Patients were excluded from the study if they had undergone eye surgery within 12 months prior to the start of the study. Patients with intraocular diseases (e.g. age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, glaucoma, serious acquired or hereditary eye diseases) or neurological disorders affecting ophthalmological examinations were also excluded from the study.
Participants received 8 g of Cornus mas fruit lyophilizate orally once daily for 6 months. The lyophilizate was administered as a powder or granulate formulation prepared as a jelly and containing potato starch and sugar.
Participants received a matching placebo formulation orally once daily for 6 months. The placebo was prepared as a jelly and contained potato starch and sugar but did not contain Cornus mas fruit lyophilizate.
Wroclaw, 50-345, Poland
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