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

NCT05546450 | Completed

• 1 other identifier: 09.2019.810
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatty Liver Disease; Obesity; Liver Fat

Keywords

Metabolic associated fatty liver disease; Cornus mas L.; diet treatment; nutrition therapy; anthropometric measurements

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (5)

Control Group

NO INTERVENTION

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

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

Diet Group

EXPERIMENTAL

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

Cornus mas L. Group

EXPERIMENTAL

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)

Healthy Control Group

NO INTERVENTION

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

Interventions

Diet 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. and Diet Group; Diet Group

Cornus mas L.(Cornelian Cherry) 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.

Cornus mas L. Group; Cornus mas L. and Diet Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Gelisim University: lead
• Marmara University: collaborator

Study Sites (1)

Istanbul Gelisim University

Istanbul, Avcılar, 34310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity; Fatty Liver

Interventions

Diet

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Hatice Merve Bayram, phD

  Istanbul Gelisim University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (Assist. Prof.)

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 19, 2022
• Study Start: April 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2022
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

TU (1)