Insulin ResistanceNCT05292300
Efficacy of Lyophilized Dried Cornus Mas L. on Anthropometric and Biochemical Parameters in Insulin Resistance
A study testing Cornelian Cherry (Cornus mas L.) and Diet in people with Insulin Resistance and Obesity, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Insulin Resistance, Obesity, PreDiabetes
- What is being tested?
- Cornelian Cherry (Cornus mas L.) and Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 May 2021to 30 Jul 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Insulin Resistance, Obesity, PreDiabetes
- Being tested
- Cornelian Cherry (Cornus mas L.), Diet
- Keywords
- Cornelian Cherry, Cornus mas L., Insulin Resistance, Nutrition, Anthropometry
- Medical subject headings
- Insulin Resistance, Obesity, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cornelian Cherry (Cornus mas L.)Dietary supplement
Patients in "Cornelian Cherry Group" and "Cornelian Cherry and Diet Group" will receive 20 g/day freeze-dried powder Cornelian Cherry supplement.
DietBehavioural
Patient in "Diet Group" and "Cornelian Cherry and Diet Group" will be given a personalized diet and be followed up by a dietician.
| 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. |
| Cornelian Cherry 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 20 g/day Cornelian Cherry powder. Receives: Dietary Supplement: Cornelian Cherry (Cornus mas L.) |
| 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 |
| Cornelian Cherry 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 20 g/day Cornelian Cherry powder for their one portion fruit a day. Receives: Dietary Supplement: Cornelian Cherry (Cornus mas L.); Behavioral: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 ).
Measured: 3 months
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 ).
Measured: 3 months
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 ).
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start24 May 2021
- Primary completion30 Apr 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Margot Celik, Marmara University
- Investigators
- Fatma Esra Güneş, PhD, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292300
- Sponsor's protocol ID
- 09.2018.652
- Status last verified
- Sep 2022
- First submitted
- 31 Aug 2021
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05292300
- Acronym / sponsor ID
- 09.2018.652
- Conditions
- Insulin Resistance, Obesity, PreDiabetes
- Keywords
- Cornelian Cherry, Cornus mas L., Insulin Resistance, Nutrition, Anthropometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 24 May 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 23 Mar 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| 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. |
| Cornelian Cherry Group | Experimental | Dietary Supplement: Cornelian Cherry (Cornus mas L.)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. |
| 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. |
| Cornelian Cherry and Diet Group | Experimental | Dietary Supplement: Cornelian Cherry (Cornus mas L.), 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 and will receive 20 g/day Cornelian Cherry powder for their one portion fruit a day. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Cornelian Cherry (Cornus mas L.)Patients in "Cornelian Cherry Group" and "Cornelian Cherry and Diet Group" will receive 20 g/day freeze-dried powder Cornelian Cherry supplement. | Dietary supplement | Cornelian Cherry Group, Cornelian Cherry and Diet Group |
| DietPatient in "Diet Group" and "Cornelian Cherry and Diet Group" will be given a personalized diet and be followed up by a dietician. | Behavioural | Cornelian Cherry and Diet Group, Diet Group |
Primary outcome
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 ).
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 ).
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 ).
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.
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.
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 29 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Fatma Esra Güneş, PhD study director
Marmara 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 Cornelian Cherry (Cornus mas L.) and Diet in people with Insulin Resistance and Obesity, run by Marmara 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 5 inclusion and 5 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 29 Sep 2022. 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 the Fasting Blood Glucose (mg/dl) at 12 weeks (time frame: 3 months). The study lists 5 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 29 Sep 2022.