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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Liver Fat; Fatty Liver Disease
• Intervention / Treatment: Behavioral: Diet; Dietary supplement: Cornus mas L.(Cornelian Cherry)

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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Avcılar
    • Istanbul, Avcılar, Turkey, 34310
      • İstanbul Gelisim University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Among those who applied to the clinic, those who do not want to follow their diet will be randomized into this group.
Experimental: Diet Group; 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.	Behavioral: Diet; Patient in "Diet Group" and "Cornus mas L. and Diet Group" will be given a personalized diet and be followed up by a dietician.
Experimental: Cornus mas L. and Diet Group; 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.	Behavioral: Diet; Patient in "Diet Group" and "Cornus mas L. and Diet Group" will be given a personalized diet and be followed up by a dietician.; Dietary supplement: Cornus mas L.(Cornelian Cherry); Patients in "Cornus mas L. Group" and "Cornus mas L. and Diet Group" will receive 30 g/day freeze-dried Cornus mas L. fruit powder supplement.
Experimental: Cornus mas L. Group; 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	Dietary supplement: Cornus mas L.(Cornelian Cherry); Patients in "Cornus mas L. Group" and "Cornus mas L. and Diet Group" will receive 30 g/day freeze-dried Cornus mas L. fruit powder supplement.
No Intervention: Healthy Control Group; This group included healthy individuals who were not diagnosed with Metabolic Associated Fatty Liver.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in fasting blood glucose (mg/dL) at 8 weeks	The fasting blood glucose at the baseline and 8 weeks later will be taken noted from the routinely requested tests in the hospital. These values will be recorded for all groups; Control Group, the Diet Group (who received a diet for 8 weeks), Cornelian Cherry and Diet Group (who received an additional 30 g/day of dried powdered Cornelian Cherry with their diet), Cornelian Cherry Group (who was given only 30 g/day of dried powdered Cornelian Cherry ), and Healthy Control Group.	8 weeks
Change from baseline in blood lipid parameters (mg/dL) at 8 weeks	The total triglyceride, cholesterol, LDL, and HDL at the baseline and 8 weeks later will be taken noted from the routinely requested tests in the hospital. These values will be recorded for all groups; Control Group, the Diet Group (who received a diet for 8 weeks), Cornelian Cherry and Diet Group (who received an additional 30 g/day of dried powdered Cornelian Cherry with their diet), Cornelian Cherry Group (who was given only 30 g/day of dried powdered Cornelian Cherry ), and Healthy Control Group.	8 weeks
Change from baseline in Aspartate transaminase (AST) (u/L) at 8 weeks	The AST levels at the baseline and 8 weeks later will be taken noted from the routinely requested tests in the hospital. These values will be recorded for all groups; Control Group, the Diet Group (who received a diet for 8 weeks), Cornelian Cherry and Diet Group (who received an additional 30 g/day of dried powdered Cornelian Cherry with their diet), Cornelian Cherry Group (who was given only 30 g/day of dried powdered Cornelian Cherry ), and Healthy Control Group.	8 weeks
Change from baseline in BMI (kg/m2) at 8 weeks	The body weight (kg) and height (m) of the patients with metabolic-associated fatty liver disease will be taken every 15 days for 8 weeks by trained and qualified nutritionists using standardized procedures and noted in their files. Height will be measured to the nearest 0.1 cm using a stadiometer, with shoes off. Tanita SC-330 (Accurate Technology Co., Ltd. Tianjin, China) was used to analyze body composition, and the subjects' body weight, percentage of lean mass, and fat were recorded. Body mass index (BMI) will be calculated as weight (kg) divided by height (m) squared.	8 weeks
Change from baseline in fasting insulin (mU/L) at 8 weeks	The fasting insulin at the baseline and 8 weeks later will be taken noted from the routinely requested tests in the hospital. These values will be recorded for all groups; Control Group, the Diet Group (who received a diet for 8 weeks), Cornelian Cherry and Diet Group (who received an additional 30 g/day of dried powdered Cornelian Cherry with their diet), Cornelian Cherry Group (who was given only 30 g/day of dried powdered Cornelian Cherry ), and Healthy Control Group.	8 weeks
Change from baseline in HOMA-IR at 8 weeks	The HOMA-IR at the baseline and 8 weeks later will be taken noted from the routinely requested tests in the hospital. These values will be recorded for all groups; Control Group, the Diet Group (who received a diet for 8 weeks), Cornelian Cherry and Diet Group (who received an additional 30 g/day of dried powdered Cornelian Cherry with their diet), Cornelian Cherry Group (who was given only 30 g/day of dried powdered Cornelian Cherry ), and Healthy Control Group.	8 weeks
Change from baseline in hbA1c (%) at 8 weeks	The hbA1c at the baseline and 8 weeks later will be taken noted from the routinely requested tests in the hospital. These values will be recorded for all groups; Control Group, the Diet Group (who received a diet for 8 weeks), Cornelian Cherry and Diet Group (who received an additional 30 g/day of dried powdered Cornelian Cherry with their diet), Cornelian Cherry Group (who was given only 30 g/day of dried powdered Cornelian Cherry ), and Healthy Control Group.	8 weeks
Change from baseline in Alanine Transaminase (ALT) (u/L) at 8 weeks	The ALT at the baseline and 8 weeks later will be taken noted from the routinely requested tests in the hospital. These values will be recorded for all groups; Control Group, the Diet Group (who received a diet for 8 weeks), Cornelian Cherry and Diet Group (who received an additional 30 g/day of dried powdered Cornelian Cherry with their diet), Cornelian Cherry Group (who was given only 30 g/day of dried powdered Cornelian Cherry ), and Healthy Control Group.	8 weeks
Change from baseline in Gamma-Glutamyl Transpeptidase (GGT) (u/L) at 8 weeks	The GGT at the baseline and 8 weeks later will be taken noted from the routinely requested tests in the hospital. These values will be recorded for all groups; Control Group, the Diet Group (who received a diet for 8 weeks), Cornelian Cherry and Diet Group (who received an additional 30 g/day of dried powdered Cornelian Cherry with their diet), Cornelian Cherry Group (who was given only 30 g/day of dried powdered Cornelian Cherry ), and Healthy Control Group.	8 weeks
Change from baseline in Alkaline phosphatase (ALP) (u/L) at 8 weeks	The ALP at the baseline and 8 weeks later will be taken noted from the routinely requested tests in the hospital. These values will be recorded for all groups; Control Group, the Diet Group (who received a diet for 8 weeks), Cornelian Cherry and Diet Group (who received an additional 30 g/day of dried powdered Cornelian Cherry with their diet), Cornelian Cherry Group (who was given only 30 g/day of dried powdered Cornelian Cherry ), and Healthy Control Group.	8 weeks
Change from baseline in circumference measurements (meters) at 8 weeks	Circumference measurements will be taken every 15 days for 8 weeks by trained and qualified nutritionists using standardized procedures.These measurements are; waist circumference (cm), hip circumference(cm), mid-upper arm circumference(cm), neck circumference(cm), waist to height ratio(cm) and waist to hip ratio(cm). Circumferences will be measured using a non-stretch plastic tape measure with an accuracy of 1 mm.	8 weeks

Collaborators and Investigators

• Sponsor: Istanbul Gelisim University
• Collaborators: Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: September 9, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 19, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: anthropometric measurements; nutrition therapy; Metabolic associated fatty liver disease; diet treatment; Cornus mas L.
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 09.2019.810

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No