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Completed

NCT Number: NCT05546450

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

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.

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Key information

Conditions

Fatty Liver Disease Body Weight Digestive System Diseases Fatty Liver Liver Diseases Liver Fat Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Gelisim University

Istanbul, Avcılar, 34310, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.(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.

Primary outcomes

  1. Change from baseline in fasting blood glucose (mg/dL) at 8 weeks

    Time frame: 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.

  2. Change from baseline in blood lipid parameters (mg/dL) at 8 weeks

    Time frame: 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.

  3. Change from baseline in Aspartate transaminase (AST) (u/L) at 8 weeks

    Time frame: 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.

  4. Change from baseline in BMI (kg/m2) at 8 weeks

    Time frame: 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.

  5. Change from baseline in fasting insulin (mU/L) at 8 weeks

    Time frame: 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.

  6. Change from baseline in HOMA-IR at 8 weeks

    Time frame: 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.

  7. Change from baseline in hbA1c (%) at 8 weeks

    Time frame: 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. Change from baseline in Alanine Transaminase (ALT) (u/L) at 8 weeks

    Time frame: 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.

  9. Change from baseline in Gamma-Glutamyl Transpeptidase (GGT) (u/L) at 8 weeks

    Time frame: 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.

  10. Change from baseline in Alkaline phosphatase (ALP) (u/L) at 8 weeks

    Time frame: 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.

  11. Change from baseline in circumference measurements (meters) at 8 weeks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul Gelisim University

Other

Collaborators

  • Marmara University

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 19, 2022
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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