Clinical trial NCT05546450: Effect of Lyophilized Cornus Mas L. on Anthropometric and Biochemical Parameters in Metabolic Associated Fatty Liver Disease Patients
Official title: Determination of the Effect of Lyophilized Dried Cornus Mas L. Fruit Powder on Nutritional Status in Individuals With Metabolic Associated Fatty Liver Disease Combined With Medical Nutrition Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatty Liver Disease
Obesity
Liver Fat
Keywords: Metabolic associated fatty liver disease
Cornus mas L.
diet treatment
nutrition therapy
anthropometric measurements
Lead sponsor: Istanbul Gelisim University
Sponsor class: OTHER
Collaborators: name: Marmara University
First posted: 2022-09-19
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in fasting blood glucose (mg/dL) at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline in blood lipid parameters (mg/dL) at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline in Aspartate transaminase (AST) (u/L) at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline in BMI (kg/m2) at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline in fasting insulin (mU/L) at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline in HOMA-IR at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline in hbA1c (%) at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline in Alanine Transaminase (ALT) (u/L) at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline in Gamma-Glutamyl Transpeptidase (GGT) (u/L) at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline in Alkaline phosphatase (ALP) (u/L) at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline in circumference measurements (meters) at 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Gelisim University
state: Avcılar
Study officials:
affiliation: Istanbul Gelisim University
name: Hatice Merve Bayram, phD
role: PRINCIPAL_INVESTIGATOR
References: