Effect of Lyophilized Cornus Mas L. on Anthropometric and Biochemical Parameters in Metabolic Associated Fatty Liver Disease Patients

Istanbul Gelisim University

Status: Completed

Conditions: Obesity; Liver Fat; Fatty Liver Disease

Treatments: Dietary Supplement: Cornus mas L.(Cornelian Cherry); Behavioral: Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05546450

09.2019.810

Details and patient eligibility

About

The aim of the study was to evaluate the effect of lyophilized Cornus mas L. fruit powder with/without diet therapy on biochemical parameters and anthropometric measurements in patients with metabolic associated fatty liver disease.

Full description

The main purpose of this study is to determine the efficacy of the lyophilized dried powder form of cornelian cherry (Cornus mas L.) grown in our country on nutritional status and biochemical parameters in patients with metabolic-associated fatty liver disease.

Sub-objectives of the study;

• Determination of the effect of cornelian cherry on blood glucose, and lipid parameters, and liver enzymes.
• Determination of anti-inflammatory, antidiabetic, and antioxidant effects of cornelian cherry in metabolic fatty liver patients.
• Determination of the effect of cornelian cherry on anthropometric measurements.

The aim of this study is to compare the anthropometric measurements and biomarkers of patients with metabolic-associated fatty liver disease as a result of the consumption of powdered cornelian cherry (Cornus mas L.) that has been freeze-dried at -55 degrees with a Lyophilizer device for 8 weeks.

Enrollment: 108 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged between 18 and 65 years with metabolic associated fatty liver.
• Those who applied to the gastroenterology clinic
• Volunteers
• Those who signed the consent form

Exclusion criteria

• Those with <18 to ≥65 years
• Those without ultrasonography results
• Those with >20 g/day for men and 10 g/day for women alcohol consumption in the past 1 year
• Those with hepatitis B or C
• Those with chronic liver diseases associated with viral hepatitis, such as Wilson disease, hemochromatosis, and Cushing syndrome
• Those with autoimmune liver disease
• Those with a history of cardiovascular diseases, cancer, mental diseases, severe liver, and kidney dysfunction
• Those with thyroid diseases such as goiter, hypothyroidism, or hyperthyroidism
• Those with prolonged use of estrogen or regular consumption of drugs associated with fatty liver diseases, such as corticosteroid, methotrexate, tamoxifen, and amiodarone
• Pregnant, breastfeeding women
• Those with allergic to Cornus mas fruit
• Those with an unwillingness to continue the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 5 patient groups

Control Group

No Intervention group

Description:

Among those who applied to the clinic, those who do not want to follow their diet will be randomized into this group.

Cornus mas L. and Diet Group

Experimental group

Description:

Among those who applied to the clinic, those who want to follow their diet will be randomized into this group. Patients in this group will be followed by a personalized diet and will receive 30 g/day lyophilized Cornus mas L. fruit powder for their one portion of fruit a day.

Treatment:

Dietary Supplement: Cornus mas L.(Cornelian Cherry)

Behavioral: Diet

Diet Group

Experimental group

Description:

Among those who applied to the clinic, those who want to follow their diet will be randomized into this group. Patients in this group will be followed by a personalized diet.

Treatment:

Behavioral: Diet

Cornus mas L. Group

Experimental group

Description:

Among those who applied to the clinic, those who do not want to follow their diet will be randomized into this group. Patients in this group will receive 30 g/day lyophilized Cornus mas L. fruit powder

Treatment:

Dietary Supplement: Cornus mas L.(Cornelian Cherry)

Healthy Control Group

No Intervention group

Description:

This group included healthy individuals who were not diagnosed with Metabolic Associated Fatty Liver.