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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Change from baseline in fasting blood glucose (mg/dL) at 8 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change from baseline in fasting blood glucose (mg/dL) at 8 weeks
时间窗: 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.
Change from baseline in hbA1c (%) at 8 weeks
时间窗: 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.
Change from baseline in blood lipid parameters (mg/dL) at 8 weeks
时间窗: 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.
Change from baseline in HOMA-IR at 8 weeks
时间窗: 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.
Change from baseline in BMI (kg/m2) at 8 weeks
时间窗: 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.
Change from baseline in circumference measurements (meters) at 8 weeks
时间窗: 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.
Change from baseline in Alanine Transaminase (ALT) (u/L) at 8 weeks
时间窗: 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.
Change from baseline in Aspartate transaminase (AST) (u/L) at 8 weeks
时间窗: 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.
Change from baseline in fasting insulin (mU/L) at 8 weeks
时间窗: 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.
Change from baseline in Alkaline phosphatase (ALP) (u/L) at 8 weeks
时间窗: 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.
Change from baseline in Gamma-Glutamyl Transpeptidase (GGT) (u/L) at 8 weeks
时间窗: 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.
次要结局
未报告次要终点
研究者
Hatice Merve Bayram
Principal Investigator (Assist. Prof.)
Istanbul Gelisim University