Fatty Liver DiseaseNCT05546450
Effect of Lyophilized Cornus Mas L. on Anthropometric and Biochemical Parameters in Metabolic Associated Fatty Liver Disease Patients
A study testing Diet and Cornus mas L.(Cornelian Cherry) in people with Fatty Liver Disease and Obesity, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fatty Liver Disease, Obesity, Liver Fat
- What is being tested?
- Diet and Cornus mas L.(Cornelian Cherry)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Gelisim University
Istanbul, Avcılar, 34310
About this study
Official 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
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.
Read the 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
- Being tested
- Diet, Cornus mas L.(Cornelian Cherry)
- Keywords
- Metabolic associated fatty liver disease, Cornus mas L., diet treatment, nutrition therapy, anthropometric measurements
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start1 Apr 2022
- Primary completion1 Jun 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Gelisim University
- Sponsor type
- University, hospital or other
- Collaborators
- Marmara University
- Responsible party
- Principal investigator, Hatice Merve Bayram, Istanbul Gelisim University
- Investigators
- Hatice Merve Bayram, phD, Principal investigator, Istanbul Gelisim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546450
- Sponsor's protocol ID
- 09.2019.810
- Status last verified
- Mar 2023
- First submitted
- 9 Sep 2022
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05546450
- Acronym / sponsor ID
- 09.2019.810
- Conditions
- Fatty Liver Disease, Obesity, Liver Fat
- Keywords
- Metabolic associated fatty liver disease, Cornus mas L., diet treatment, nutrition therapy, anthropometric measurements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Istanbul Gelisim UniversityUniversity, hospital or other
- Collaborators
- Marmara University
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Diet, Dietary Supplement: Cornus mas L.(Cornelian Cherry)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. |
| Diet Group | Experimental | Behavioral: DietAmong 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. |
| Cornus mas L. Group | Experimental | Dietary Supplement: Cornus mas L.(Cornelian Cherry)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 |
| Healthy Control Group | No intervention | –This group included healthy individuals who were not diagnosed with Metabolic Associated Fatty Liver. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietPatient in "Diet Group" and "Cornus mas L. and Diet Group" will be given a personalized diet and be followed up by a dietician. | Behavioural | Cornus mas L. and Diet Group, Diet Group |
| 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. | Dietary supplement | Cornus mas L. Group, Cornus mas L. and Diet Group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hatice Merve Bayram, phD principal investigator
Istanbul Gelisim University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and Cornus mas L.(Cornelian Cherry) in people with Fatty Liver Disease and Obesity, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in fasting blood glucose (mg/dL) at 8 weeks (time frame: 8 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.