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Efficacy of Lyophilized Dried Cornus Mas L. on Anthropometric and Biochemical Parameters in Insulin Resistance

Primary Purpose

Insulin Resistance, Obesity, PreDiabetes

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cornelian Cherry (Cornus mas L.)
Diet
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance focused on measuring Cornelian Cherry, Cornus mas L., Insulin Resistance, Nutrition, Anthropometry

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Marmara University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control Group

Cornelian Cherry Group

Diet Group

Cornelian Cherry and Diet Group

Arm Description

Among those who applied to the clinic, those who do not want to follow their diet will be randomized into this 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.

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.

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.

Outcomes

Primary Outcome Measures

Change from Baseline in the Fasting Blood Glucose (mg/dl) at 12 weeks
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 ).
Change from Baseline in the Fasting Insulin (mU/L) at 12 weeks
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 ).
Change from Baseline in the HOMA-IR at 12 weeks
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 ).
Change from Baseline in the BMI (kg/m2)
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.
Change from Baseline in the Anthropometric Measurements
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.

Secondary Outcome Measures

Full Information

First Posted
August 31, 2021
Last Updated
September 27, 2022
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT05292300
Brief Title
Efficacy of Lyophilized Dried Cornus Mas L. on Anthropometric and Biochemical Parameters in Insulin Resistance
Official Title
Investigation of the Efficacy of Lyophilized Dried Cornelian Cherry (Cornus Mas L.) Fruit on Anthropometric and Biochemical Parameters in Women With Insulin Resistance
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 24, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to determine the effect of 3 months supplementation of lyophilize dried cornelian cherry (Cornus mas L.) on women diagnosed with insulin resistance. The baseline and end biochemical parameters and anthropometric measurements will be compared with control subjects.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Obesity, PreDiabetes
Keywords
Cornelian Cherry, Cornus mas L., Insulin Resistance, Nutrition, Anthropometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Among those who applied to the clinic, those who do not want to follow their diet will be randomized into this group.
Arm Title
Cornelian Cherry Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Diet Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Cornelian Cherry and Diet Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Cornelian Cherry (Cornus mas L.)
Intervention Description
Patients in "Cornelian Cherry Group" and "Cornelian Cherry and Diet Group" will receive 20 g/day freeze-dried powder Cornelian Cherry supplement.
Intervention Type
Behavioral
Intervention Name(s)
Diet
Intervention Description
Patient in "Diet Group" and "Cornelian Cherry and Diet Group" will be given a personalized diet and be followed up by a dietician.
Primary Outcome Measure Information:
Title
Change from Baseline in the Fasting Blood Glucose (mg/dl) at 12 weeks
Description
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 ).
Time Frame
3 months
Title
Change from Baseline in the Fasting Insulin (mU/L) at 12 weeks
Description
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 ).
Time Frame
3 months
Title
Change from Baseline in the HOMA-IR at 12 weeks
Description
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 ).
Time Frame
3 months
Title
Change from Baseline in the BMI (kg/m2)
Description
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.
Time Frame
3 months
Title
Change from Baseline in the Anthropometric Measurements
Description
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.
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma Esra Güneş, PhD
Organizational Affiliation
Marmara University
Official's Role
Study Director
Facility Information:
Facility Name
Marmara University
City
Istanbul
State/Province
Maltepe
ZIP/Postal Code
34854
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Lyophilized Dried Cornus Mas L. on Anthropometric and Biochemical Parameters in Insulin Resistance

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