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

NCT ID: NCT05546450

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-09-01

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.

Conditions

Fatty Liver Disease; Obesity; Liver Fat

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Diet

Intervention Type: BEHAVIORAL

Patient in "Diet Group" and "Cornus mas L. and Diet Group" will be given a personalized diet and be followed up by a dietician.

Cornus mas L.(Cornelian Cherry)

Intervention Type: DIETARY_SUPPLEMENT

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.

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.

Group Type: EXPERIMENTAL

Diet

Intervention Type: BEHAVIORAL

Patient in "Diet Group" and "Cornus mas L. and Diet Group" will be given a personalized diet and be followed up by a dietician.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Cornus mas L.(Cornelian Cherry)

Intervention Type: DIETARY_SUPPLEMENT

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.

Healthy Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: collaborator

Istanbul Gelisim University

OTHER

Sponsor Role: lead

Responsible Party

Hatice Merve Bayram

Principal Investigator (Assist. Prof.)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hatice Merve Bayram, phD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Gelisim University

Locations

Istanbul Gelisim University

Istanbul, Avcılar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

09.2019.810

Identifier Type: -

Identifier Source: org_study_id