- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05292300
Efficacy of Lyophilized Dried Cornus Mas L. on Anthropometric and Biochemical Parameters in Insulin Resistance
Investigation of the Efficacy of Lyophilized Dried Cornelian Cherry (Cornus Mas L.) Fruit on Anthropometric and Biochemical Parameters in Women With Insulin Resistance
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The main purpose of this study is to determine the efficacy of the lyophilizer-dried powder form of cornelian cherry (Cornus mas L.) grown in our country on inflammation in women with insulin resistance by biochemical parameters.
Sub-objectives of the study;
- Determining the presence of inflammation in women with insulin resistance.
- Determination of the effect of cornelian cherry on both fasting blood glucose, insulin and blood lipid profile.
- Determination of both anti-inflammatory, antidiabetic and antioxidant effects of cornelian cherry.
- Determination of the effect of cornelian cherry on anthropometric measurements.
The aim of this study is to compare the anthropometric measurements and biomarkers of women with insulin resistance 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 12 weeks.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maltepe
-
Istanbul, Maltepe, Turkey, 34854
- Marmara University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women aged between 18 and 45 years with insulin resistance.
- Those who have not experienced menopause
- Those who applied to the obesity clinic
- Volunteers
- Those who signed the consent form
Exclusion Criteria:
- Those who use medicine for diabetes and thyroid diseases,
- Those taking hormone therapy
- Pregnant and lactating women
- Those with a history of cancer
- Patients with communication problems.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
Among those who applied to the clinic, those who do not want to follow their diet will be randomized into this group.
|
|
Experimental: Cornelian Cherry 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 20 g/day Cornelian Cherry powder.
|
Patients in "Cornelian Cherry Group" and "Cornelian Cherry and Diet Group" will receive 20 g/day freeze-dried powder Cornelian Cherry supplement.
|
Experimental: 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.
|
Patient in "Diet Group" and "Cornelian Cherry and Diet Group" will be given a personalized diet and be followed up by a dietician.
|
Experimental: Cornelian Cherry 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 20 g/day Cornelian Cherry powder for their one portion fruit a day.
|
Patients in "Cornelian Cherry Group" and "Cornelian Cherry and Diet Group" will receive 20 g/day freeze-dried powder Cornelian Cherry supplement.
Patient in "Diet Group" and "Cornelian Cherry and Diet Group" will be given a personalized diet and be followed up by a dietician.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in the Fasting Blood Glucose (mg/dl) at 12 weeks
Time Frame: 3 months
|
The fasting blood glucose (mg/dl) at the baseline and 12 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 3 months), Cornelian Cherry and Diet Group (who received additional 20 g/day of dried powdered Cornelian Cherry with their diet), Cornelian Cherry Group (who was given only 20 g/day of dried powdered Cornelian Cherry ).
|
3 months
|
Change from Baseline in the Fasting Insulin (mU/L) at 12 weeks
Time Frame: 3 months
|
The fasting insulin (mU/L) values of the women with insulin resistance at the baseline and 12 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 3 months), Cornelian Cherry and Diet Group (who received additional 20 g/day of dried powdered Cornelian Cherry with their diet), Cornelian Cherry Group (who was given only 20 g/day of dried powdered Cornelian Cherry ).
|
3 months
|
Change from Baseline in the HOMA-IR at 12 weeks
Time Frame: 3 months
|
The fasting blood glucose (mg/dl) and fasting insulin (mU/L) values of the women with insulin resistance at the baseline and 12 weeks later will be taken noted from the routinely requested tests in the hospital.
HOMA-IR will be calculated with the formula (fasting glucose (mg/dl) x fasting insulin (mU/L)) / 405.
These values will be recorded for all groups; Control Group, the Diet Group (who received a diet for 3 months), Cornelian Cherry and Diet Group (who received additional 20 g/day of dried powdered Cornelian Cherry with their diet), Cornelian Cherry Group (who was given only 20 g/day of dried powdered Cornelian Cherry ).
|
3 months
|
Change from Baseline in the BMI (kg/m2)
Time Frame: 3 months
|
The body weight (kg) and height (m) of the women with insulin resistance at the baseline, 4 weeks, 8 weeks and 12 weeks will be taken by the researcher and noted in their files. The height of the patients will be measured with a fixed height meter with 0.5 cm intervals, with shoes off. For body analysis, an 8-electrode bioelectrical impedance (BIA) device Tanita MC 780 MA, which performs segmental analysis, will be used. Patients will be asked to remove all metal items (rings, earrings, bracelets, watches, phones, etc.), any heavy clothing, shoes, and socks before stepping on the device. The device is set to -1.0 kg for the remaining clothes. From these measurements, body weight, body fat (kg), body fat percentage (%), body muscle (kg) and body water (kg) values will be recorded. Body mass index (BMI) will be calculated as weight (kg) divided by height (m) squared. |
3 months
|
Change from Baseline in the Anthropometric Measurements
Time Frame: 3 months
|
The anthropometric measurements of the women with insulin resistance at the baseline, 4, 8 and 12 weeks will be taken by the researcher.
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).
Waist circumference will be measured using an inflexible tape at the umbilicus level after normal exhalation to the nearest 0-1 cm.
Hip circumference will be measured from the widest area between the waist and the thigh.
The waist-to-hip will be calculated from the formula waist(cm)/hip(cm) and waist-to-height ratios will be calculated from the formula waist(cm)/height(cm). Middle-upper arm circumference will be measured on the left arm of the patients.
Neck circumference will be measured with the shoulders in the free position from the point where the thyroid cartilage is most protruding.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Fatma Esra Güneş, PhD, Marmara University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2018.652
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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