Metabolic SyndromeNCT06673914
EFFECTS OF OLEUROPEIN ON BLOOD PARAMETERS AND INFLAMMATORY MARKERS IN ADULTS WITH METABOLIC SYNDROME
A study testing Oleuropein and Diet Group in people with Metabolic Syndrome and Insulin Resistance, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of 6 weeks supplementation of oleuropein on individuals diagnosed with metabolic syndrome. 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 49 years
- Conditions the study is for
- Metabolic Syndrome, Insulin Resistance, Obesity, Abdominal
- What is being tested?
- Oleuropein and Diet Group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals who volunteer to participate in the study by signing the voluntary consent form
- Diagnosed with Metabolic Syndrome
- Individuals who did not have any infection at the time the study started
- Not consuming any medication
- Not pregnant or lactating
- Women aged 18-49 who have not entered menopause and men in the same age group
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- Willing to consume the given extract
- Not allergic or intolerant to olive leaves
- No history of drug use
- People with a BMI below 40 kg/m2
Who cannot join
- The patient included in the study leaves the study
- Any health issues that may affect the results of the research during the research.
- Occurrence of the problem and/or infection
- Becoming pregnant during the research
- Being in the experimental group and not consuming extract regularly
- Failure to comply with the regulated medical nutrition treatment
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- Failure to participate in routine meetings and failure to complete necessary measurements
- Starting to use any medication or nutritional supplement during the study
- Leaving study voluntarily
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine the effect of 6 weeks supplementation of oleuropein on individuals diagnosed with metabolic syndrome. The baseline and end biochemical parameters and anthropometric measurements will be compared with control subjects.
Read the detailed description
This study was conducted to investigate the effect of adding oleuropein to the medical nutrition therapy of individuals with metabolic syndrome on their anthropometric measurements and biochemical parameters.
Sub-objectives of the study;
Determining the presence of inflammation in patiens with metabolic syndrome Determination of the effect of diet and diet combined with oleuropein on both fasting blood glucose, insulin and blood lipid profile.
Determination of both anti-inflammatory and antidiabetic effects of oleuropein. Determination of the effect of diet and diet combined with oleuropein on anthropometric measurements.
The aim of this study is to compare the anthropometric measurements and biomarkers of patients with metabolic syndrome as a result of the medical nutrition therpy with consumption of olive leaf extract (2 times a day) that has been contain 100 mg oleuropein for 6 weeks.
- Conditions
- Metabolic Syndrome, Insulin Resistance, Obesity, Abdominal, Obesity
- Being tested
- Control Group: Diet Group, Oleuropein and Diet Group
- Keywords
- metabolic syndrome, oleuropein, medical nutrition therapy
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance, Obesity, Abdominal, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Group: Diet GroupBehavioural
Patient in "Diet Group" and "Oleuropein and Diet Group" will be given a personalized diet and be followed up by a dietician.
Oleuropein and Diet GroupDietary supplement
Dietary Supplement: Oleuropein (Olive Leaf Extract) Patients in "Oleuropein and Diet Group" will receive 200 mg/day oleuropein supplement and personalized diet followed up by a dietician.
| Study group | Role | What they receive |
|---|---|---|
| Control Group: Diet Group | Active comparator | Control Group: 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 be followed up by a dietician. Receives: Behavioral: Control Group: Diet Group |
| Experimental: Oleuropein 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 2 capsules which100 grams of standardized oleuropein-containing olive leaf extract. Receives: Behavioral: Control Group: Diet Group; Dietary Supplement: Oleuropein and Diet Group |
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 6 weeks
The fasting blood glucose (mg/dl) at the baseline and 6 weeks later noted from the routinely requested tests in the hospital. These values recorded for all groups.
Measured: 6 weeks
Change from Baseline in the Insulin (uU/mL) at 6 weeks
The fasting blood glucose (mg/dl) at the baseline and 6 weeks later noted from the routinely requested tests in the hospital. These values recorded for all groups.
Measured: 6 weeks
Change from Baseline in the Triglyceride (TG) (mg/dl), high density lipoprotein (HDL-C) (mg/dl), low density lipoprotein (LDL-C) (mg/dl), Total Cholesterol (mg/dl) at 6 weeks
Triglyceride (TG) (mg/dl), high density lipoprotein (HDL-C) (mg/dl), low density lipoprotein (LDL-C) (mg/dl), Total Cholesterol (mg/dl) at the baseline and 6 weeks later noted from the routinely requested tests in the hospital. These values recorded for all groups.
Measured: 6 weeks
Change from Baseline in the HOMA-IR at 6 weeks
The fasting blood glucose (mg/dl) and fasting insulin (mU/L) values of the individuals with metabolic syndrome at the baseline and 6 weeks later noted from the routinely requested tests in the hospital. HOMA-IR calculated with the formula (fasting glucose (mg/dl) x fasting insulin (mU/L)) / 405. These values recorded for all groups.
Measured: 6 weeks
Change from Baseline in the BMI (kg/m2)
The body weight (kg) and height (m) of the individuals with metabolic syndrome were measured at the baseline and again after 6 weeks by the researcher, who noted the values in their files. The height of the patients was measured with a fixed height meter at 0.5 cm intervals, with shoes off.
For body analysis, an 8-electrode bioelectrical impedance (BIA) device, Inbody 270, which performs segmental analysis, was used. Patients were 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 was set to -1.0 kg to account for the remaining clothes.
From these measurements, body weight, body fat (kg), body fat percentage (%), body muscle (kg), and body water (kg) values were recorded. Body mass index (BMI) was calculated as weight (kg) divided by height (m) squared.
Measured: 6 weeks
Change from Baseline in the Anthropometric Measurements
The anthropometric measurements of the individuals with metabolic syndrome at the baseline and 6 weeks taken by the researcher and noted in their files. These measurements included waist circumference (cm), hip circumference (cm), mid-upper arm circumference (cm), waist-to-height ratio (cm), and waist-to-hip ratio (cm). Waist circumference was measured using an inflexible tape at the umbilicus level after normal exhalation to the nearest 0.1 cm. Hip circumference was measured from the widest area between the waist and the thigh. The waist-to-hip ratio was calculated using the formula waist (cm)/hip (cm), and the waist-to-height ratio was calculated using the formula waist (cm)/height (cm). Mid-upper arm circumference was measured on the left arm of the patients. Neck circumference was measured with the shoulders in a free position from the point where the thyroid cartilage was most protruding.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Nov 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulen Ecem Kalkan, Atlas University
- Investigators
- Gülen Ecem Kalkan, PhD, Principal investigator, Atlas UniversityMüveddet Emel Alphan, Prof, Study director, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673914
- Sponsor's protocol ID
- EcemMS
- Status last verified
- Nov 2024
- First submitted
- 23 Jul 2024
- Last updated
- 5 Nov 2024
- 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 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF OLEUROPEIN ON BLOOD PARAMETERS AND INFLAMMATORY MARKERS IN ADULTS WITH METABOLIC SYNDROME
- ClinicalTrials.gov ID
- NCT06673914
- Acronym / sponsor ID
- EcemMS
- Conditions
- Metabolic Syndrome, Insulin Resistance, Obesity, Abdominal, Obesity
- Keywords
- metabolic syndrome, oleuropein, medical nutrition therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 5 Nov 2024 (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 6 weeks supplementation of oleuropein on individuals diagnosed with metabolic syndrome. The baseline and end biochemical parameters and anthropometric measurements will be compared with control subjects.
Detailed description
This study was conducted to investigate the effect of adding oleuropein to the medical nutrition therapy of individuals with metabolic syndrome on their anthropometric measurements and biochemical parameters.
Sub-objectives of the study;
Determining the presence of inflammation in patiens with metabolic syndrome Determination of the effect of diet and diet combined with oleuropein on both fasting blood glucose, insulin and blood lipid profile.
Determination of both anti-inflammatory and antidiabetic effects of oleuropein. Determination of the effect of diet and diet combined with oleuropein on anthropometric measurements.
The aim of this study is to compare the anthropometric measurements and biomarkers of patients with metabolic syndrome as a result of the medical nutrition therpy with consumption of olive leaf extract (2 times a day) that has been contain 100 mg oleuropein for 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group: Diet Group | Active comparator | Behavioral: Control Group: Diet GroupControl Group: 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 be followed up by a dietician. |
| Experimental: Oleuropein and Diet Group | Experimental | Behavioral: Control Group: Diet Group, Dietary Supplement: Oleuropein and Diet GroupAmong 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 2 capsules which100 grams of standardized oleuropein-containing olive leaf extract. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Individuals who volunteer to participate in the study by signing the voluntary consent form
- Diagnosed with Metabolic Syndrome
- Individuals who did not have any infection at the time the study started
- Not consuming any medication
- Not pregnant or lactating
Key exclusion criteria (9 listed)
- The patient included in the study leaves the study
- Any health issues that may affect the results of the research during the research.
- Occurrence of the problem and/or infection
- Becoming pregnant during the research
- Being in the experimental group and not consuming extract regularly
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 |
|---|---|---|
| Control Group: Diet GroupPatient in "Diet Group" and "Oleuropein and Diet Group" will be given a personalized diet and be followed up by a dietician. | Behavioural | Control Group: Diet Group, Experimental: Oleuropein and Diet Group |
| Oleuropein and Diet GroupDietary Supplement: Oleuropein (Olive Leaf Extract) Patients in "Oleuropein and Diet Group" will receive 200 mg/day oleuropein supplement and personalized diet followed up by a dietician. | Dietary supplement | Experimental: Oleuropein and Diet Group |
Primary outcome
Change from Baseline in the Fasting Blood Glucose (mg/dl) at 6 weeks
Time frame: 6 weeks
The fasting blood glucose (mg/dl) at the baseline and 6 weeks later noted from the routinely requested tests in the hospital. These values recorded for all groups.
Change from Baseline in the Insulin (uU/mL) at 6 weeks
Time frame: 6 weeks
The fasting blood glucose (mg/dl) at the baseline and 6 weeks later noted from the routinely requested tests in the hospital. These values recorded for all groups.
Change from Baseline in the Triglyceride (TG) (mg/dl), high density lipoprotein (HDL-C) (mg/dl), low density lipoprotein (LDL-C) (mg/dl), Total Cholesterol (mg/dl) at 6 weeks
Time frame: 6 weeks
Triglyceride (TG) (mg/dl), high density lipoprotein (HDL-C) (mg/dl), low density lipoprotein (LDL-C) (mg/dl), Total Cholesterol (mg/dl) at the baseline and 6 weeks later noted from the routinely requested tests in the hospital. These values recorded for all groups.
Change from Baseline in the HOMA-IR at 6 weeks
Time frame: 6 weeks
The fasting blood glucose (mg/dl) and fasting insulin (mU/L) values of the individuals with metabolic syndrome at the baseline and 6 weeks later noted from the routinely requested tests in the hospital. HOMA-IR calculated with the formula (fasting glucose (mg/dl) x fasting insulin (mU/L)) / 405. These values recorded for all groups.
Change from Baseline in the BMI (kg/m2)
Time frame: 6 weeks
The body weight (kg) and height (m) of the individuals with metabolic syndrome were measured at the baseline and again after 6 weeks by the researcher, who noted the values in their files. The height of the patients was measured with a fixed height meter at 0.5 cm intervals, with shoes off. For body analysis, an 8-electrode bioelectrical impedance (BIA) device, Inbody 270, which performs segmental analysis, was used. Patients were 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 was set to -1.0 kg to account for the remaining clothes. From these measurements, body weight, body fat (kg), body fat percentage (%), body muscle (kg), and body water (kg) values were recorded. Body mass index (BMI) was calculated as weight (kg) divided by height (m) squared.
Change from Baseline in the Anthropometric Measurements
Time frame: 6 weeks
The anthropometric measurements of the individuals with metabolic syndrome at the baseline and 6 weeks taken by the researcher and noted in their files. These measurements included waist circumference (cm), hip circumference (cm), mid-upper arm circumference (cm), waist-to-height ratio (cm), and waist-to-hip ratio (cm). Waist circumference was measured using an inflexible tape at the umbilicus level after normal exhalation to the nearest 0.1 cm. Hip circumference was measured from the widest area between the waist and the thigh. The waist-to-hip ratio was calculated using the formula waist (cm)/hip (cm), and the waist-to-height ratio was calculated using the formula waist (cm)/height (cm). Mid-upper arm circumference was measured on the left arm of the patients. Neck circumference was measured with the shoulders in a free position from the point where the thyroid cartilage was most protruding.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- 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.
Gülen Ecem Kalkan, PhD principal investigator
Atlas University
Müveddet Emel Alphan, Prof study director
Atlas 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 Oleuropein and Diet Group in people with Metabolic Syndrome and Insulin Resistance, run by Atlas 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 10 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
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 6 weeks (time frame: 6 weeks). The study lists 6 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 5 Nov 2024.