WomenNCT06485349
Olive Leaf Extract, Meta-inflammation, Anxiety, and Excess Weight
A study testing Olive Leaf Extract (OLE) in people with Women and Excess Weight, run by University of Guadalajara at 1 site in Mexico.
Trial summary
Excess Weight is accompanied by a process that produces a low-grade inflammation state, called meta-inflammation. Anxiety is also associated with inflammation. Inflammation is closely related to oxidative stress. Both processes help perpetuate each other. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Women, Excess Weight, Anxiety Disorders
- What is being tested?
- Olive Leaf Extract (OLE)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteMexico
- Study dates
- 16 Oct 2024to 31 Jan 2026
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females.
- Residing in Guadalajara Metropolitan Area (GMA).
- Initial age ≥18-≤ 40 years
- Initial Body Mass Index (BMI) ≥25-≤40 kg/m^2
- Blood pressure: ≤129mmHg systolic and ≤80 diastolic.
- Anxious symptomatology score 6 to 14 (mild) through the Hamilton Anxiety Scale (HAS).
Who cannot join
- Use of psychoactive drugs, suffering from major psychiatric disorders (depression, attention deficit hyperactivity disorder, bipolar disorder, eating disorders), pregnancy, breastfeeding, hypotension, alcohol use disorder (AUD).
- Suffer from liver, kidney, or thyroid disease or cancer.
- Olive allergy.
- Consume any medication that influences weight
- Consume some other type of food supplement from organic origin.
- Less than 70% adherence frequency to the consumption of the extract/placebo.
- Getting pregnant during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Olive Leaf Extract Effects on Meta-inflammation and Anxiety Symptoms in Women With Excess Weight
Excess Weight is accompanied by a process that produces a low-grade inflammation state, called meta-inflammation. Anxiety is also associated with inflammation. Inflammation is closely related to oxidative stress. Both processes help perpetuate each other. Olive Leaf Extract (OLE) is known for having anti-inflammatory and antioxidant effects; by this means, its anxiolytic effect has been proved in animal models. The purpose of this investigation is to evaluate the anti-inflammatory and anxiolytic effects associated with the supplementation of OLE at a daily dose of 750mg (20% oleuropein) for 3 months.
Read the detailed description
A randomized double-blind placebo clinical trial is proposed. Study groups will be comprised of women living with excessive weight from the Guadalajara Metropolitan Area who meet the following criteria: age ≥18- ≤40 years, body mass index (BMI) ≥25- ≤40 kg/m^2, blood pressure ≤ 129 mmHg systolic and ≤80 diastolic; anxiety symptomatology score 6 to 14 (mild) according to Hamilton Anxiety Scale (HAS).
70 women at the University Center for Health Sciences (CUCS) from Universidad de Guadalajara who meet inclusion criteria will be invited to participate. Two groups will be randomly formed consisting of 35 women with excessive weight and anxious symptoms each (by the BMI and HAS score, respectively); 35 will receive cellulose (100 mg) as a placebo, and the other 35, 750 mg/day of Olive Leaf Extract (OLE) orally, daily, for 90 days. Participants would be instructed to consume it after breakfast without modifying their eating patterns.
Anxious symptomatology will be measured by HAS and Beck Anxiety Inventory (BAI), alternately, every 30 days for 90 days; at the beginning, it would be HAS, after 30 days, investigators will apply BAI, then, after the next thirty days HAS (day 60) and, finally, will end the study applying BAI (day 90). Alternation of these tests is done to avoid bias in patients that allows them to recognize answers to obtain better scores.
Treatment adherence will be reviewed on a biweekly basis. At the same time, biweekly, participants will have to fill out a nutritional 24-hour food recall and a food frequency questionnaire and will also be asked if it is their desire to keep participating or not in the investigation.
To evaluate meta-inflammation, levels of leptin, IL-6, TNF-α, and cortisol in serum will be quantified using the ELISA technique. This will be done by doing a blood extraction at the beginning and another one at the end of the study (day 90). These two extractions will also be used to measure the patient's lipid profile (LDL cholesterol; LDL-c, total cholesterol; TC, triglycerides; TG and HDL-cholesterol; HDL-c) and glycosylated hemoglobin.
At the beginning of the study, investigators will apply a nutritional clinic history that contains information on eating habits (24-hour recall and food frequency), clinical history, and family health history. Anthropometric parameters such as weight, height, age, and BMI will be recorded; also, the percentage of body fat and muscle through bioimpedance. Height will be measured with a stadiometer. Weight and components associated with excessive weight such as percentage of body fat and muscle will be recorded monthly using an Omron® HBF-514C bioimpedance scale.
- Conditions
- Women, Excess Weight, Anxiety Disorders
- Being tested
- Olive Leaf Extract (OLE), Placebo
- Keywords
- Olive leaf extract, Women, Meta-inflammation, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive Leaf Extract (OLE)Dietary supplement
Also called Olive leaf extract Nutricost ® 750mg 20% oleuropein
Daily dose of 750mg OLE consumed with water after breakfast without any modification of their dietary patterns for 90 days.
PlaceboOther
100mg microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Olive Leaf Extract (OLE) Nutricost ® 750mg 20% oleuropein with 250ml of water. Receives: Dietary Supplement: Olive Leaf Extract (OLE) |
| Placebo | Placebo comparator | 100mg cellulose with 250ml of water. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TNF-α concentration
Measured by ELISA assay (Enzyme-Linked ImmunoSorbent Assay) according to the manufacturer's recommendations. The kit is a Human TNF-α ELISA kit; measured in pg/mL.
Measured: Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).
Change in IL-6 concentration
Measured by ELISA assay (Enzyme-Linked ImmunoSorbent Assay) according to the manufacturer's recommendations. The kit is a Human IL-6 ELISA kit; measured in pg/mL
Measured: Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).
Change in leptine concentration
Measured by ELISA assay (Enzyme-Linked ImmunoSorbent Assay) according to the manufacturer's recommendations. The kit is a Human leptin ELISA kit; measured in pg/mL
Measured: Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).
Change in cortisol concentration
Measured by ELISA assay (Enzyme-Linked ImmunoSorbent Assay) according to the manufacturer's recommendations. The kit is a Human cortisol ELISA kit; measured in pg/mL.
Measured: Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).
Change in Anxiety symptomatology scored by Hamilton Anxiety Scale (HAS)
Measured in accordance to the next score: 0-5, absence of anxiety; 6-14, mild anxiety; ≥15, moderate/severe anxiety, on an alternately, monthly, basis; in the morning in a peaceful controlled environment.
Measured: From baseline, day 0, pre-supplementation, up to day 60, during supplementation. It will be applied bimonthly, twice in total.
Change in Anxiety symptomatology scored by Beck Anxiety Index (BAI)
Measured in accordance to the next score: 0-5, absence of anxiety; 6-15, mild anxiety; 16-30, moderate anxiety; 31-63 severe anxiety, on an alternately, monthly, basis; in the morning in a peaceful controlled environment.
Measured: Its first application will be on day 30, during supplementation, up to day 90 (24 hours after the last supplement/placebo intake). It will be applied bimonthly, twice in total.
Secondary outcomes (8)
Change in weight
In kilograms (kg). Measured every month, in the morning, lightly clothed, with an Omron® HBF-514C bioimpedance scale in a peaceful controlled environment.
Measured: From baseline, day 0, pre-supplementation. Then, during supplementation it will be measured monthly, meaning day 30, day 60 up to day 90 (24 hours after the last supplement/placebo intake).
Change in body fat percentage
Expressed in percentage (%). Measured every month, in the morning, lightly clothed, with an Omron® HBF-514C bioimpedance scale in a peaceful controlled environment.
Measured: From baseline, day 0, pre-supplementation. Then, during supplementation it will be measured monthly, meaning day 30, day 60 up to day 90 (24 hours after the last supplement/placebo intake).
Change in body muscle percentage
Expressed in percentage (%). Measured every month, in the morning, lightly clothed, with an Omron® HBF-514C bioimpedance scale in a peaceful controlled environment.
Measured: From baseline, day 0, pre-supplementation. Then, during supplementation it will be measured monthly, meaning day 30, day 60 up to day 90 (24 hours after the last supplement/placebo intake).
Change in lipid profile
Total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein: Blood serum would be taken from the participants after an overnight fast of 12 h; lipid profiles (triglycerides, total cholesterol, HDL-C, and LDL-C) would be determined using a piece of semi-automated equipment (Mindray-BS-240 Clinical Chemistry Analyzer, Shenzhen, China) and colorimetric enzymatic assays (BioSystems® kits, Barcelona, Spain). Measured in mg/dl.
Measured: Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).
Change in glycosylated hemoglobin
Blood serum would be taken from the participants after an overnight fast of 12 h; glycosylated hemoglobin would be determined using a piece of semi-automated equipment (Mindray-BS-240 Clinical Chemistry Analyzer, Shenzhen, China) and colorimetric enzymatic assays (BioSystems® kits, Barcelona, Spain). Measured in percentage (%).
Measured: Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).
24 hour dietary intake recall
Taken on a biweekly basis to analyze the dietary intake consumed the previous day and measure their approximate caloric intake and macronutrient relationship with the Mexican Food Equivalent System.
Measured: Its first application will be on day 15, during supplementation. Then, it will be applied on a biweekly basis, meaning day 30, day 45, day 60, day 75 up to day 90 (24 hours after the last supplement/placebo intake).
Food Frequency Questionnaire
Taken on a biweekly basis to analyze their food consumption according to their group classification.
Measured: Its first application will be on day 15, during supplementation. Then, it will be applied on a biweekly basis, meaning day 30, day 45, day 60, day 75 up to day 90 (24 hours after the last supplement/placebo intake).
Change in BMI
Weight and height will be combined to report BMI in kg/m^2 and it will be measured every month according to their actual weight-height relation.
Measured: From baseline, day 0, pre-supplementation. Then, during supplementation it will be measured monthly, meaning day 30, day 60 up to day 90 (24 hours after the last supplement/placebo intake).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start16 Oct 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WomenStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Excess-weight women with mild anxiety symptomatology will be assigned in a control double-blind and randomized manner to one of two groups: olive leaf extract (OLE) (n=35) 750 mg 20% oleuropein or placebo (n=35). Participants would have sessions biweekly: 1. (Day 0, 30, 60, and 90): Anxious symptomatology, weight, height, body fat, and muscle percentage (blood extraction at day 0 and day 90). 2. (Day 15, 45, 75): Adherence, 24-hour recall, and Food frequency questionnaire (FFQ). Supplementation starts at day 0 and ends at day 89. Anxious symptomatology is evaluated, monthly, alternatively with the Hamilton Anxiety Scale (HAS) and Beck Anxiety Inventory (BAI). Adherence will be verified every 15 days as well as a 24-hour dietary recall and FFQ. ELISA assays will be used for TNF-α, IL-6, Cortisol, and leptin quantifications. It will be performed with 12h overnight fasting, in the morning; and lipid profile and glycosylated hemoglobin will be measured through biochemical tests.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma. Sonia Luquín de Anda, University of Guadalajara
- Investigators
- Ma. Sonia Luquin, Ph.D, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485349
- Sponsor's protocol ID
- 24-11
- Status last verified
- Oct 2024
- First submitted
- 14 Jun 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available. It will only be shared the data that underlie the results reported in this article, after deidentification. The study protocol, statistical analysis plan, and informed consent form are already in the document attached to this registry. Data will be available beginning 3 months and ending 2 years after article publication. It will be shared with anyone who provides a methodologically sound proposal, to achieve its aims. The proposal should be directed to sonia.luquin@academicos.udg.mx or to mario.hernandez6110@alumnos.udg.mx. To gain access, data requestors will need to sign a data access agreement. Data will be available to the requestors at this link: https://drive.google.com/drive/folders/1tL75USV4bsrOAvb5A-7-H3CcOowq-T1V?usp=drive\_link
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olive Leaf Extract Effects on Meta-inflammation and Anxiety Symptoms in Women With Excess Weight
- ClinicalTrials.gov ID
- NCT06485349
- Acronym / sponsor ID
- 24-11
- Conditions
- Women, Excess Weight, Anxiety Disorders
- Keywords
- Olive leaf extract, Women, Meta-inflammation, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 3 Jul 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.
Excess Weight is accompanied by a process that produces a low-grade inflammation state, called meta-inflammation. Anxiety is also associated with inflammation. Inflammation is closely related to oxidative stress. Both processes help perpetuate each other. Olive Leaf Extract (OLE) is known for having anti-inflammatory and antioxidant effects; by this means, its anxiolytic effect has been proved in animal models. The purpose of this investigation is to evaluate the anti-inflammatory and anxiolytic effects associated with the supplementation of OLE at a daily dose of 750mg (20% oleuropein) for 3 months.
Detailed description
A randomized double-blind placebo clinical trial is proposed. Study groups will be comprised of women living with excessive weight from the Guadalajara Metropolitan Area who meet the following criteria: age ≥18- ≤40 years, body mass index (BMI) ≥25- ≤40 kg/m^2, blood pressure ≤ 129 mmHg systolic and ≤80 diastolic; anxiety symptomatology score 6 to 14 (mild) according to Hamilton Anxiety Scale (HAS).
70 women at the University Center for Health Sciences (CUCS) from Universidad de Guadalajara who meet inclusion criteria will be invited to participate. Two groups will be randomly formed consisting of 35 women with excessive weight and anxious symptoms each (by the BMI and HAS score, respectively); 35 will receive cellulose (100 mg) as a placebo, and the other 35, 750 mg/day of Olive Leaf Extract (OLE) orally, daily, for 90 days. Participants would be instructed to consume it after breakfast without modifying their eating patterns.
Anxious symptomatology will be measured by HAS and Beck Anxiety Inventory (BAI), alternately, every 30 days for 90 days; at the beginning, it would be HAS, after 30 days, investigators will apply BAI, then, after the next thirty days HAS (day 60) and, finally, will end the study applying BAI (day 90). Alternation of these tests is done to avoid bias in patients that allows them to recognize answers to obtain better scores.
Treatment adherence will be reviewed on a biweekly basis. At the same time, biweekly, participants will have to fill out a nutritional 24-hour food recall and a food frequency questionnaire and will also be asked if it is their desire to keep participating or not in the investigation.
To evaluate meta-inflammation, levels of leptin, IL-6, TNF-α, and cortisol in serum will be quantified using the ELISA technique. This will be done by doing a blood extraction at the beginning and another one at the end of the study (day 90). These two extractions will also be used to measure the patient's lipid profile (LDL cholesterol; LDL-c, total cholesterol; TC, triglycerides; TG and HDL-cholesterol; HDL-c) and glycosylated hemoglobin.
At the beginning of the study, investigators will apply a nutritional clinic history that contains information on eating habits (24-hour recall and food frequency), clinical history, and family health history. Anthropometric parameters such as weight, height, age, and BMI will be recorded; also, the percentage of body fat and muscle through bioimpedance. Height will be measured with a stadiometer. Weight and components associated with excessive weight such as percentage of body fat and muscle will be recorded monthly using an Omron® HBF-514C bioimpedance scale.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Excess-weight women with mild anxiety symptomatology will be assigned in a control double-blind and randomized manner to one of two groups: olive leaf extract (OLE) (n=35) 750 mg 20% oleuropein or placebo (n=35). Participants would have sessions biweekly: 1. (Day 0, 30, 60, and 90): Anxious symptomatology, weight, height, body fat, and muscle percentage (blood extraction at day 0 and day 90). 2. (Day 15, 45, 75): Adherence, 24-hour recall, and Food frequency questionnaire (FFQ). Supplementation starts at day 0 and ends at day 89. Anxious symptomatology is evaluated, monthly, alternatively with the Hamilton Anxiety Scale (HAS) and Beck Anxiety Inventory (BAI). Adherence will be verified every 15 days as well as a 24-hour dietary recall and FFQ. ELISA assays will be used for TNF-α, IL-6, Cortisol, and leptin quantifications. It will be performed with 12h overnight fasting, in the morning; and lipid profile and glycosylated hemoglobin will be measured through biochemical tests.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Dietary Supplement: Olive Leaf Extract (OLE)Olive Leaf Extract (OLE) Nutricost ® 750mg 20% oleuropein with 250ml of water. |
| Placebo | Placebo comparator | Other: Placebo100mg cellulose with 250ml of water. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Females.
- Residing in Guadalajara Metropolitan Area (GMA).
- Initial age ≥18-≤ 40 years
- Initial Body Mass Index (BMI) ≥25-≤40 kg/m^2
- Blood pressure: ≤129mmHg systolic and ≤80 diastolic.
Key exclusion criteria (7 listed)
- Use of psychoactive drugs, suffering from major psychiatric disorders (depression, attention deficit hyperactivity disorder, bipolar disorder, eating disorders), pregnancy, breastfeeding, hypotension, alcohol use disorder (AUD).
- Suffer from liver, kidney, or thyroid disease or cancer.
- Olive allergy.
- Consume any medication that influences weight
- Consume some other type of food supplement from organic origin.
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 |
|---|---|---|
| Olive Leaf Extract (OLE)Also: Olive leaf extract Nutricost ® 750mg 20% oleuropeinDaily dose of 750mg OLE consumed with water after breakfast without any modification of their dietary patterns for 90 days. | Dietary supplement | Experimental |
| Placebo100mg microcrystalline cellulose | Other | Placebo |
Primary outcome
Change in TNF-α concentration
Time frame: Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).
Measured by ELISA assay (Enzyme-Linked ImmunoSorbent Assay) according to the manufacturer's recommendations. The kit is a Human TNF-α ELISA kit; measured in pg/mL.
Change in IL-6 concentration
Time frame: Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).
Measured by ELISA assay (Enzyme-Linked ImmunoSorbent Assay) according to the manufacturer's recommendations. The kit is a Human IL-6 ELISA kit; measured in pg/mL
Change in leptine concentration
Time frame: Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).
Measured by ELISA assay (Enzyme-Linked ImmunoSorbent Assay) according to the manufacturer's recommendations. The kit is a Human leptin ELISA kit; measured in pg/mL
Change in cortisol concentration
Time frame: Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).
Measured by ELISA assay (Enzyme-Linked ImmunoSorbent Assay) according to the manufacturer's recommendations. The kit is a Human cortisol ELISA kit; measured in pg/mL.
Change in Anxiety symptomatology scored by Hamilton Anxiety Scale (HAS)
Time frame: From baseline, day 0, pre-supplementation, up to day 60, during supplementation. It will be applied bimonthly, twice in total.
Measured in accordance to the next score: 0-5, absence of anxiety; 6-14, mild anxiety; ≥15, moderate/severe anxiety, on an alternately, monthly, basis; in the morning in a peaceful controlled environment.
Change in Anxiety symptomatology scored by Beck Anxiety Index (BAI)
Time frame: Its first application will be on day 30, during supplementation, up to day 90 (24 hours after the last supplement/placebo intake). It will be applied bimonthly, twice in total.
Measured in accordance to the next score: 0-5, absence of anxiety; 6-15, mild anxiety; 16-30, moderate anxiety; 31-63 severe anxiety, on an alternately, monthly, basis; in the morning in a peaceful controlled environment.
8 secondary outcomes
Change in weight
Time frame: From baseline, day 0, pre-supplementation. Then, during supplementation it will be measured monthly, meaning day 30, day 60 up to day 90 (24 hours after the last supplement/placebo intake).
Change in body fat percentage
Time frame: From baseline, day 0, pre-supplementation. Then, during supplementation it will be measured monthly, meaning day 30, day 60 up to day 90 (24 hours after the last supplement/placebo intake).
Change in body muscle percentage
Time frame: From baseline, day 0, pre-supplementation. Then, during supplementation it will be measured monthly, meaning day 30, day 60 up to day 90 (24 hours after the last supplement/placebo intake).
Change in lipid profile
Time frame: Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).
Change in glycosylated hemoglobin
Time frame: Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).
24 hour dietary intake recall
Time frame: Its first application will be on day 15, during supplementation. Then, it will be applied on a biweekly basis, meaning day 30, day 45, day 60, day 75 up to day 90 (24 hours after the last supplement/placebo intake).
Food Frequency Questionnaire
Time frame: Its first application will be on day 15, during supplementation. Then, it will be applied on a biweekly basis, meaning day 30, day 45, day 60, day 75 up to day 90 (24 hours after the last supplement/placebo intake).
Change in BMI
Time frame: From baseline, day 0, pre-supplementation. Then, during supplementation it will be measured monthly, meaning day 30, day 60 up to day 90 (24 hours after the last supplement/placebo intake).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: Yes. Individual participant data will be available. It will only be shared the data that underlie the results reported in this article, after deidentification. The study protocol, statistical analysis plan, and informed consent form are already in the document attached to this registry. Data will be available beginning 3 months and ending 2 years after article publication. It will be shared with anyone who provides a methodologically sound proposal, to achieve its aims. The proposal should be directed to sonia.luquin@academicos.udg.mx or to mario.hernandez6110@alumnos.udg.mx. To gain access, data requestors will need to sign a data access agreement. Data will be available to the requestors at this link: https://drive.google.com/drive/folders/1tL75USV4bsrOAvb5A-7-H3CcOowq-T1V?usp=drive_link
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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.
Ma. Sonia Luquin, Ph.D principal investigator
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olive Leaf Extract (OLE) in people with Women and Excess Weight, run by University of Guadalajara at 1 site in Mexico.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Oct 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 Mexico. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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 in TNF-α concentration (time frame: Baseline, day 0, pre-supplementation, on an empty stomach, and day 90 (on an empty stomach, 24 hours after the last supplement/placebo intake).). 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 18 Oct 2024.