Effects of Cornelian Cherry Supplementation in Patients With Metabolic Syndrome

NCT07739602 | Completed

• 1 other identifier: KB-630/2018, KB 308/2026
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome

Keywords

metabolic syndrome; eye; cardiometabolic; Cornelian Cherry; natural extracts; iridoids

Outcome Measures

Primary Outcomes (34)

• 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.

  Baseline, 3 months, and 6 months

• CRP

  The CRP (C-Reactive Protein) test measures the level of C-reactive protein in blood serum, which is one of the most sensitive and rapidly responding indicators of inflammation in the body.

  Baseline, 3 months, and 6 months

• lipid profile

  A lipid profile is a blood test that measures the levels of cholesterol and triglycerides in the body. It is one of the most important preventive tests used to assess the risk of developing cardiovascular diseases, such as atherosclerosis, heart attack, or stroke.

  Baseline, 3 months, and 6 months

• urea level test

  A urea level test is a basic blood chemistry test used primarily to assess kidney function and monitor protein metabolism in the body

  Baseline, 3 months, and 6 months

• creatinine test

  A creatinine test is the most important and most sensitive laboratory blood test used to assess kidney function and filtration capacity.

  Baseline, 3 months, and 6 months

• insulin test

  An insulin test is a laboratory blood test that evaluates the body's carbohydrate metabolism and the function of the pancreas.

  Baseline, 3 months, and 6 months

• The OGTT (Oral Glucose Tolerance Test)

  The OGTT (Oral Glucose Tolerance Test), also known as the oral glucose tolerance test (commonly referred to as the glucose curve), is a key diagnostic test used to assess how well the body metabolizes carbohydrates.

  Baseline, 3 months, and 6 months

• A fibrinogen test

  A fibrinogen test is a laboratory blood test that assesses the body's ability to clot blood properly and helps detect inflammation

  Baseline, 3 months, and 6 months

• An SHBG (sex hormone-binding globulin) test

  An SHBG (sex hormone-binding globulin) test is a blood test that measures the concentration of a protein which transports hormones (mainly testosterone and oestradiol) and regulates their levels in the body. It helps doctors determine what proportion of the hormones is bound (inactive) and what proportion is biologically active.

  Baseline, 3 months, and 6 months

• cortisol test

  A cortisol test measures the level of the so-called 'stress hormone', which is produced by the adrenal glands. It is used to assess adrenal function and helps to diagnose serious hormonal disorders, such as Cushing's syndrome (excess) or Addison's disease (deficiency).

  Baseline, 3 months, and 6 months

• The 25(OH)D3 test

  The 25(OH)D3 test, which measures the concentration of 25-hydroxyvitamin D in the blood, is the most accurate indicator of vitamin D levels in the body. It enables the detection of deficiencies or excesses, which is crucial for, amongst other things, bone health and immunity.

  Baseline, 3 months, and 6 months

• A parathyroid hormone (PTH)

  A parathyroid hormone (PTH) test is a blood test that measures the level of a hormone produced by the parathyroid glands. It is crucial for diagnosing disorders of calcium and phosphate metabolism (e.g. osteoporosis, kidney stones or kidney disease) and abnormalities in the functioning of the parathyroid glands themselves (hyperparathyroidism or hypoparathyroidism).

  Baseline, 3 months, and 6 months

• plasma renin activity

  ARO stands for plasma renin activity. This blood test measures the concentration and activity of renin - an enzyme produced by the kidneys. It helps doctors diagnose and manage high blood pressure and adrenal gland disorders, particularly when combined with a measurement of aldosterone levels.

  Baseline, 3 months, and 6 months

• An aldosterone test

  An aldosterone test is a blood or urine test that measures the level of aldosterone - a hormone produced by the adrenal glands. This hormone regulates water and electrolyte balance by retaining sodium and water in the body and facilitating the excretion of potassium. The test is crucial in diagnosing high blood pressure (particularly treatment-resistant hypertension) and disorders of the kidneys and adrenal glands.

  Baseline, 3 months, and 6 months

• Adipokine tests

  Adipokine tests are blood tests that measure the levels of hormones and signalling molecules (known as adipokines) produced by adipose tissue. The most important of these are adiponectin and leptin. They enable the assessment of the risk of metabolic syndrome and type 2 diabetes, as well as the degree of insulin resistance.

  Baseline, 3 months, and 6 months

• An FMD (Flow-Mediated Dilation) ultrasound scan

  An FMD (Flow-Mediated Dilation) ultrasound scan is a non-invasive test used to assess the condition of the circulatory system, and more specifically the function of the vascular endothelium - the thin layer of cells lining the inside of blood vessels. It is a key indicator for detecting the early stages of atherosclerosis.

  Baseline, 3 months, and 6 months

• ABPM (Ambulatory Blood Pressure Monitoring)

  ABPM (Ambulatory Blood Pressure Monitoring), commonly known as a blood pressure Holter monitor, is a 24-hour (or longer) automated monitoring of blood pressure. It enables an assessment of how blood pressure changes during daily activities, at work, whilst sleeping and in stressful situations.

  Baseline, 3 months, and 6 months

• Bioimpedance analysis (BIA)

  Bioimpedance analysis (BIA) is a quick and painless test that allows you to find out exactly what your body is made of. Instead of just your overall weight, you receive precise information about the proportions of muscle, fat and water in your body.

  Baseline, 3 months, and 6 months

• Densitometry

  Densitometry is a non-invasive and painless X-ray examination used to assess bone mineral density (BMD). It is a key test for the early detection of osteopenia and osteoporosis, as well as for assessing the risk of bone fractures.

  Baseline, 3 months, and 6 months

• A urine test

  A urine test is a basic and non-invasive laboratory test that assesses the functioning of the kidneys, the urinary tract and the body as a whole. It helps with the early detection of, amongst other things, infections, diabetes, liver disease and metabolic disorders

  Baseline, 3 months, and 6 months

• a stool test

  A stool test is a non-invasive laboratory analysis of a stool sample, which enables the assessment of digestive system function, the detection of parasites, bacteria and viruses, and the identification of inflammation, bleeding or malabsorption. It is a key tool in the diagnosis of, amongst other things, diseases of the intestines, pancreas and liver.

  Baseline, 3 months, and 6 months

• the visual field test

  A visual field test (perimetry) is a painless eye test that measures the extent of the area visible to the eye whilst it is fixed on a single point. It helps to detect blind spots and assess the condition of the retina, the optic nerve and the nerve pathways in the brain.

  Baseline, 3 months, and 6 months

• A visual acuity test

  A visual acuity test is a basic ophthalmological and optometric test that assesses the eye's ability to clearly recognise shapes and details. It involves reading letters, numbers or symbols (optotypes) of various sizes from a specific distance, usually using a Snellen chart or a projector

  Baseline, 3 months, and 6 months

• An intraocular pressure test

  An intraocular pressure test (tonometry) measures the pressure of the fluid inside the eyeball. It helps to detect dangerous conditions (such as glaucoma) before they cause damage to your eyesight. Normal values range from 10 to 21 mm Hg. The test is painless and takes just a few seconds.

  Baseline, 3 months, and 6 months

• Periorbital blood flow assessment

  Periorbital blood flow assessment (often performed as an orbital Doppler ultrasound) is a non-invasive ultrasound technique used in ophthalmology to assess the velocity, direction and quality of blood flow in the blood vessels supplying the eye.

  Baseline, 3 months, and 6 months

• biomicroscopy

  Examination of the anterior segment of the eye using a slit lamp - biomicroscopy assessment of, amongst other things, the conjunctiva, cornea, anterior chamber, iris and lens.

  Baseline, 3 months, and 6 months

• funduscopy

  Examination of the back of the eye following pupil dilation - funduscopy assessment of the retina, the macula, the optic disc and the retinal vessels.

  Baseline, 3 months, and 6 months

• White Blood Cell Count

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

  Baseline, 3 months, and 6 months

• Platelet Count

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

  Baseline, 3 months, and 6 months

• Hemoglobin Concentration

  Hemoglobin concentration measured in peripheral venous blood using an automated hematology analyzer. Results will be reported in grams per deciliter.

  Baseline, 3 months, and 6 months

• Hematocrit

  Hematocrit measured in peripheral venous blood using an automated hematology analyzer. Results will be reported as the percentage of blood volume occupied by red blood cells.

  Baseline, 3 months, and 6 months

• Mean Corpuscular Volume

  Mean corpuscular volume measured in peripheral venous blood using an automated hematology analyzer. Results will be reported as the average volume of red blood cells.

  Baseline, 3 months, and 6 months

• Neutrophil Count

  Absolute neutrophil count measured in peripheral venous blood using an automated hematology analyzer. Results will be reported as the number of neutrophils per liter of blood.

  Baseline, 3 months, and 6 months

• Lymphocyte Count

  Absolute lymphocyte count measured in peripheral venous blood using an automated hematology analyzer. Results will be reported as the number of lymphocytes per liter of blood.

  Baseline, 3 months, and 6 months

Secondary Outcomes (223)

• TRPV4 ion channel activity

  Baseline, 3 months, and 6 months

• Mean change from baseline in serum alpha-crystallin A (CRYAA) concentration

  Baseline, 3 months, and 6 months

• The aldehyde dehydrogenase 1A1 (ALDH1A1) test

  Baseline, 3 months, and 6 months

• The carboxymethyllysine (CML) assay test

  Baseline, 3 months, and 6 months

• The determination of carboxyethyllysine (CEL) concentration

  Baseline, 3 months, and 6 months

Study Arms (2)

Cornus mas Supplementation

EXPERIMENTAL

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.

Dietary Supplement: Cornus mas Fruit Lyophilizate

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_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.

Also known as: Cornus mas L., Cornelian cherry

Placebo

Cornus mas Fruit Lyophilizate DIETARY_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.

Cornus mas Supplementation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Department of Pharmacology, Wroclaw Medical University

Wroclaw, 50-345, Poland

Location

Related Publications (8)

• Egert S, Baxheinrich A, Lee-Barkey YH, Tschoepe D, Wahrburg U, Stratmann B. Effects of an energy-restricted diet rich in plant-derived alpha-linolenic acid on systemic inflammation and endothelial function in overweight-to-obese patients with metabolic syndrome traits. Br J Nutr. 2014 Oct 28;112(8):1315-22. doi: 10.1017/S0007114514002001. Epub 2014 Sep 2.

  PMID: 25180479 BACKGROUND

• Jayaprakasam B, Vareed SK, Olson LK, Nair MG. Insulin secretion by bioactive anthocyanins and anthocyanidins present in fruits. J Agric Food Chem. 2005 Jan 12;53(1):28-31. doi: 10.1021/jf049018+.

  PMID: 15631504 BACKGROUND

• Jayaprakasam B, Olson LK, Schutzki RE, Tai MH, Nair MG. Amelioration of obesity and glucose intolerance in high-fat-fed C57BL/6 mice by anthocyanins and ursolic acid in Cornelian cherry (Cornus mas). J Agric Food Chem. 2006 Jan 11;54(1):243-8. doi: 10.1021/jf0520342.

  PMID: 16390206 BACKGROUND

• Asgary S, Rafieian-Kopaei M, Shamsi F, Najafi S, Sahebkar A. Biochemical and histopathological study of the anti-hyperglycemic and anti-hyperlipidemic effects of cornelian cherry (Cornus mas L.) in alloxan-induced diabetic rats. J Complement Integr Med. 2014 Jun;11(2):63-9. doi: 10.1515/jcim-2013-0022.

  PMID: 24710636 BACKGROUND

• Sozański, Tomasz, et al. "Cornelian cherry consumption increases the L-arginine/ADMA ratio, lowers ADMA and SDMA levels in the plasma, and enhances the aorta glutathione level in rabbits fed a high-cholesterol diet." Journal of Functional Foods 34 (2017): 189-196.

  BACKGROUND

• Sozanski T, Kucharska AZ, Rapak A, Szumny D, Trocha M, Merwid-Lad A, Dzimira S, Piasecki T, Piorecki N, Magdalan J, Szelag A. Iridoid-loganic acid versus anthocyanins from the Cornus mas fruits (cornelian cherry): Common and different effects on diet-induced atherosclerosis, PPARs expression and inflammation. Atherosclerosis. 2016 Nov;254:151-160. doi: 10.1016/j.atherosclerosis.2016.10.001. Epub 2016 Oct 5.

  PMID: 27744131 BACKGROUND

• Sozanski T, Kucharska AZ, Szumny A, Magdalan J, Bielska K, Merwid-Lad A, Wozniak A, Dzimira S, Piorecki N, Trocha M. The protective effect of the Cornus mas fruits (cornelian cherry) on hypertriglyceridemia and atherosclerosis through PPARalpha activation in hypercholesterolemic rabbits. Phytomedicine. 2014 Nov 15;21(13):1774-84. doi: 10.1016/j.phymed.2014.09.005. Epub 2014 Oct 25.

  PMID: 25444446 BACKGROUND

• Kucharska, Alicja Z., et al. "Iridoids and anthocyanins in cornelian cherry (Cornus mas L.) cultivars." Journal of Food Composition and Analysis 40 (2015): 95-102.

  BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized intervention

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 31, 2026
• Study Start: January 17, 2019
• Primary Completion: June 25, 2026
• Study Completion: June 25, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)