Metabolic SyndromePhase 2NCT06061926
Effect of Celery Seed on the Components of Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
A Phase 2 study testing Celery Seed in people with Metabolic Syndrome, run by University of Guadalajara at 1 site in Mexico.
Trial summary
The Metabolic Syndrome (MS) is a cluster of cardiometabolic risk factors, which include abdominal obesity, hyperglycemia, dyslipidemia, and high blood pressure. MS is a global health problem, it represents a risk factor for the progression of cardiovascular disease, which constitute the main cause of mortality in the… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Celery Seed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteMexico
- Study dates
- 20 May 2023to Dec 2025
- Phase
- Phase 2
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients both sexes
- Age between 30 and 60 years
- Diagnosis of metabolic syndrome (MS) according to the IDF criteria: waist circumference: ≥80 cm (women) ≥90 cm (men), plus two or more of the following:
- Fasting glucose ≥ 100 mg/dL
- Triglycerides ≥150 mg/dL
- HDL-c: Men ≤40 mg/dL, women ≤50 mg/dL
Show all 11Show fewer
- Blood pressure ≥130/85 mmHg
- Body Mass Index from 25 to 34.9 kg/m²
- Stable weight at least the previous last 3 months (weight variation less than 10%)
- No pharmacological treatment for MS, insulin sensitivity and insulin secretion
- Acceptance and signing of informed consent
Who cannot join
- Pregnancy or breast-feeding
- Glucose ≥126 mg/dL
- Total cholesterol ≥240 mg/dL
- Triglycerides ≥500mg/dL
- Systolic blood pressure ≥140 mmHg
- Diastolic blood pressure ≥90 mmHg
- Drugs or supplements consumption with proven properties that modify the behavior of the study variables.
- History of kidney, liver or thyroid disease
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
INSTITUTO DE TERAPÉUTICA EXPERIMENTAL Y CLÍNICA. Centro Universitario de Ciencias de la Salud
Guadalajara, Jalisco, 44340
Karina G Pérez-Rubio, PhD, +523310585200 ext. 34212, karina2410@hotmail.com
Marisol Cortez Navarrete, PhD, +523310585200 ext. 34212, cortez_marisol@hotmail.com
About this study
Official title: Effect of Celery Seed (Apium Graveolens L.) Administration on the Components of Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
The Metabolic Syndrome (MS) is a cluster of cardiometabolic risk factors, which include abdominal obesity, hyperglycemia, dyslipidemia, and high blood pressure. MS is a global health problem, it represents a risk factor for the progression of cardiovascular disease, which constitute the main cause of mortality in the world and in Mexico. The current treatment involves lifestyle changes and pharmacological treatment for each of the components of MS, however, there is no single approved treatment to control all components. Celery seed (Apium graveolens L.) from the Apiaceae family contains the flavonoids apigenin and luteolin; essential oils such as d-limonene, selinene and phthalides such as 3-n-butylphthalide. Thanks to its bioactive components, celery seed has proven to be effective in treating individual MS disorders; however, most studies are in animal models and there are no clinical studies that evaluate its effectiveness on all components of the system. MS, insulin sensitivity and insulin secretion so it could appear as a new, safe and effective complementary therapy for the treatment of MS.
The aim of this study is to evaluate the effect of celery seed on the components of metabolic syndrome, insulin sensitivity, and insulin secretion.
Read the detailed description
A randomized, double-blind controlled clinical trial in 28 patients between 30 to 60 years of age with a diagnosis of MS according to the International Diabetes Federation (IDF) criteria without treatment and whether they voluntary accept participating and signing the informed consent.
Patients with one or more of the following criteria will be excluded: History of kidney, thyroid or liver disease; systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg, fasting glucose ≥ 126 mg/dL, triglycerides ≥ 500 mg/dL, total cholesterol ≥240 mg/dL; pregnancy or lactation; consumption of medications or supplements with effects on the study variables.
Patients included, may be withdrawn from the study if they meet any of the following conditions: Withdrawal of the informed consent, treatment adherence <80%, severe adverse reaction, intolerance or hypersensitivity to celery seed or placebo.
They will be assigned randomly two groups of 14 patients; one of the groups will receive 75 mg of celery seed twice at day (before breakfast and dinner) for 12 weeks.
The other group will receive homologated placebo (calcined magnesia) twice at day (before breakfast and dinner) for 12 weeks.
Waist circumference, blood pressure, fasting blood glucose, serum triglycerides and serum HDL cholesterol will be evaluated before and after intervention in both groups. Insulin sensitivity (Matsuda index), total insulin secretion (it is the result of the ratio between the area under the curve (AUC) of insulin in a 2-h OGTT and the AUC of glucose in a 2-h OGTT) and First phase of insulin secretion (Stumvoll index), will be calculated from the concentration of glucose and insulin obtained from an Oral Glucose Tolerance Test.
This protocol It´s already approved by the local ethics committee and written informed consent it´s going to be obtained from all volunteers.
Statistical analysis will be presented through measures of central tendency and dispersion, mean and deviation standard for quantitative variables; frequencies and percentage for qualitative variable. The analysis between groups (independent samples) will be analyzed using the Mann-Whitney U test for quantitative variables and the X2 test or Fisher's exact test for qualitative variables. The intragroup analysis (two related samples) will be performed using the Wilcoxon range test for quantitative variables. Statistical significance will be considered with a p<0.05.
- Conditions
- Metabolic Syndrome
- Being tested
- Celery Seed, Placebo
- Keywords
- Celery seed, Metabolic Syndrome, Insulin resistance, Insulin secretion, Insulin sensitivity
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celery SeedDrug
Also called Apium graveolens Leen
Celery seed capsules (Apium graveolens L.) 150 mg twice times at day, one capsule with 75 mg before breakfast and one capsule with 75 mg before dinner during 12 weeks. Homologated to the other intervention. Oral administration.
PlaceboDrug
Also called Calcined magnesia
Placebo capsules (calcined magnesia) twice times at day, one capsule before breakfast and one capsule before dinner during 12 weeks. Homologated to the other intervention. Oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Celery seed | Experimental | 14 patients to receive homologated intervention capsule (celery seed 150 mg) one capsule with 75 mg of celery seed, every 12 hours (before breakfast and before dinner) along 12 weeks. Receives: Drug: Celery Seed |
| Placebo | Placebo comparator | 14 patients to receive homologated placebo capsule (calcinated magnesia) one capsule with calcinated magnesia, every 12 hours (before breakfast and before dinner) along 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist Circumference (WC)
Waist Circumference will be evaluated at baseline and week 12 by World Health Organization technique
Measured: Baseline to week 12 (end of intervention)
Systolic Blood Pressure (SBP)
Systolic Blood Pressure (SBP) will be measured at baseline and week 12 with a digital sphygmomanometer three times in each arm to get an average
Measured: Baseline to week 12 (end of intervention)
Diastolic Blood Pressure (DBP)
Diastolic Blood Pressure (DBP) will be measured at baseline and week 12 with a digital sphygmomanometer three times in each arm to get an average
Measured: Baseline to week 12 (end of intervention)
High-Density Lipoprotein (HDL-c)
High density lipoprotein (HDL-c) level will be evaluated at baseline and week 12 by enzymatic- colorimetric technique to get c-HDL level
Measured: Baseline to week 12 (end of intervention)
Fasting Blood Triglycerides Concentration (TG)
Fasting Blood Triglycerides Concentration (TG) level will be evaluated at baseline and week 12 by enzymatic- colorimetric technique to get triglycerides concentration
Measured: Baseline to week 12 (end of intervention)
Fasting Serum Glucose (FSG)
The Fasting Serum Glucose (FSG) levels will be evaluated at baseline and week 12 by enzymatic- colorimetric technique to get fasting glucose level
Measured: Baseline to week 12 (end of intervention)
Insulin Sensitivity (Matsuda Index)
Insulin sensitivity will be calculated at baseline and week 12 with Matsuda index to get insulin sensitivity
Measured: Baseline to week 12 (end of intervention)
Total Insulin Secretion
Total insulin secretion will be calculated at baseline and week 12. It is the result of the ratio between the AUC of insulin in a 2-h OGTT and the AUC of glucose in a 2-h OGTT. It allows estimating the proportion of total insulin secretion in relation to plasma glucose concentration.
Measured: Baseline to week 12 (end of intervention)
First Phase of Insulin Secretion (Stumvoll Index)
The first phase if insulin secretion will be calculated at baseline and week 12 with Stumvoll index to get first phase of insulin secretion
Measured: Baseline to week 12 (end of intervention)
Secondary outcomes (12)
Body weight
Body weight will be measured at baseline and week 12 with a bioimpedance analysis
Measured: Baseline to week 12 (end of intervention)
Body Mass Index (BMI)
Body Mass Index (BMI) will be calculated at baseline and week 12 with the Quetelet index formula
Measured: Baseline to week 12 (end of intervention)
Body Fat Percentage
Body fat percentage will be measured at baseline and week 12 with a bioimpedance analysis
Measured: Baseline to week 12 (end of intervention)
Total Cholesterol (TC)
Total Cholesterol (TC) level will be evaluated at baseline and week 12 by enzymatic- colorimetric technique to get total cholesterol level
Measured: Baseline to week 12 (end of intervention)
Low Density Lipoprotein (LDL-c)
Low Density Lipoprotein (LDL-c) level will be calculated at baseline and week 12 with Friedewald formula to get LDL-c level
Measured: Baseline to week 12 (end of intervention)
Very Low Density Lipoprotein (VLDL)
Very Low Density Lipoprotein (VLDL) level will be calculated at baseline and week 12 with triglycerides concentration/5 formula to get VLDL level
Measured: Baseline to week 12 (end of intervention)
Concentration of Blood Aspartate Aminostransferase (AST)
Concentration of Blood Aspartate Aminostransferase (AST) level will be evaluated at baseline and week 12 by enzymatic-colorimetric technique to get AST level
Measured: Baseline to week 12 (end of intervention)
Alanine Aminotransferase (ALT)
Concentration of Blood Alanine Aminostransferase (ALT) level will be evaluated at baseline and week 12 by enzymatic-colorimetric technique to get ALT level
Measured: Baseline to week 12 (end of intervention)
Creatinine
Concentration of creatinine level will be evaluated at baseline and week 12 by enzymatic-colorimetric technique to get creatinine level
Measured: Baseline to week 12 (end of intervention)
Uric Acid
Concentration of uric acid level will be evaluated at baseline and week 12 by enzymatic-colorimetric technique to get uric acid level
Measured: Baseline to week 12 (end of intervention)
Incidence of treatment-Emergent Adverse Events
Incidence of treatment-Emergent Adverse Events of celery seed or placebo will be identified by clinical evaluation from baseline week to week 12 with continuous surveillance
Measured: Baseline to week 12 (end of intervention)
Tolerability to treatment
Tolerability to treatment of celery seed or placebo will be identified by clinical evaluation from baseline week to week 12 with continuous surveillance
Measured: Baseline to week 12 (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start20 May 2023
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karina Griselda Pérez Rubio, University of Guadalajara
- Investigators
- Karina G Pérez Rubio, PhD, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061926
- Sponsor's protocol ID
- Celery Seed-MS
- Status last verified
- Oct 2024
- First submitted
- 25 Sep 2023
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Escobedo-Gutierrez MJ, Cortez-Navarrete M, Martinez-Abundis E, Perez-Rubio KG. Effect of Celery Seed (Apium graveolens L.) Administration on the Components of Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion: A Clinical Trial. Pharmaceuticals (Basel). 2026 Jan 7;19(1):110. doi: 10.3390/ph19010110.
PubMed 41599709
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Celery Seed (Apium Graveolens L.) Administration on the Components of Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
- ClinicalTrials.gov ID
- NCT06061926
- Acronym / sponsor ID
- Celery Seed-MS
- Conditions
- Metabolic Syndrome
- Keywords
- Celery seed, Metabolic Syndrome, Insulin resistance, Insulin secretion, Insulin sensitivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 20 May 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Sep 2023 (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 Metabolic Syndrome (MS) is a cluster of cardiometabolic risk factors, which include abdominal obesity, hyperglycemia, dyslipidemia, and high blood pressure. MS is a global health problem, it represents a risk factor for the progression of cardiovascular disease, which constitute the main cause of mortality in the world and in Mexico. The current treatment involves lifestyle changes and pharmacological treatment for each of the components of MS, however, there is no single approved treatment to control all components. Celery seed (Apium graveolens L.) from the Apiaceae family contains the flavonoids apigenin and luteolin; essential oils such as d-limonene, selinene and phthalides such as 3-n-butylphthalide. Thanks to its bioactive components, celery seed has proven to be effective in treating individual MS disorders; however, most studies are in animal models and there are no clinical studies that evaluate its effectiveness on all components of the system. MS, insulin sensitivity and insulin secretion so it could appear as a new, safe and effective complementary therapy for the treatment of MS.
The aim of this study is to evaluate the effect of celery seed on the components of metabolic syndrome, insulin sensitivity, and insulin secretion.
Detailed description
A randomized, double-blind controlled clinical trial in 28 patients between 30 to 60 years of age with a diagnosis of MS according to the International Diabetes Federation (IDF) criteria without treatment and whether they voluntary accept participating and signing the informed consent.
Patients with one or more of the following criteria will be excluded: History of kidney, thyroid or liver disease; systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg, fasting glucose ≥ 126 mg/dL, triglycerides ≥ 500 mg/dL, total cholesterol ≥240 mg/dL; pregnancy or lactation; consumption of medications or supplements with effects on the study variables.
Patients included, may be withdrawn from the study if they meet any of the following conditions: Withdrawal of the informed consent, treatment adherence <80%, severe adverse reaction, intolerance or hypersensitivity to celery seed or placebo.
They will be assigned randomly two groups of 14 patients; one of the groups will receive 75 mg of celery seed twice at day (before breakfast and dinner) for 12 weeks.
The other group will receive homologated placebo (calcined magnesia) twice at day (before breakfast and dinner) for 12 weeks.
Waist circumference, blood pressure, fasting blood glucose, serum triglycerides and serum HDL cholesterol will be evaluated before and after intervention in both groups. Insulin sensitivity (Matsuda index), total insulin secretion (it is the result of the ratio between the area under the curve (AUC) of insulin in a 2-h OGTT and the AUC of glucose in a 2-h OGTT) and First phase of insulin secretion (Stumvoll index), will be calculated from the concentration of glucose and insulin obtained from an Oral Glucose Tolerance Test.
This protocol It´s already approved by the local ethics committee and written informed consent it´s going to be obtained from all volunteers.
Statistical analysis will be presented through measures of central tendency and dispersion, mean and deviation standard for quantitative variables; frequencies and percentage for qualitative variable. The analysis between groups (independent samples) will be analyzed using the Mann-Whitney U test for quantitative variables and the X2 test or Fisher's exact test for qualitative variables. The intragroup analysis (two related samples) will be performed using the Wilcoxon range test for quantitative variables. Statistical significance will be considered with a p<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blind, controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Celery seed | Experimental | Drug: Celery Seed14 patients to receive homologated intervention capsule (celery seed 150 mg) one capsule with 75 mg of celery seed, every 12 hours (before breakfast and before dinner) along 12 weeks. |
| Placebo | Placebo comparator | Drug: Placebo14 patients to receive homologated placebo capsule (calcinated magnesia) one capsule with calcinated magnesia, every 12 hours (before breakfast and before dinner) along 12 weeks. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Patients both sexes
- Age between 30 and 60 years
- Diagnosis of metabolic syndrome (MS) according to the IDF criteria: waist circumference: ≥80 cm (women) ≥90 cm (men), plus two or more of the following:
- Body Mass Index from 25 to 34.9 kg/m²
- Stable weight at least the previous last 3 months (weight variation less than 10%)
Key exclusion criteria (8 listed)
- Pregnancy or breast-feeding
- Glucose ≥126 mg/dL
- Total cholesterol ≥240 mg/dL
- Triglycerides ≥500mg/dL
- Systolic blood pressure ≥140 mmHg
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 |
|---|---|---|
| Celery SeedAlso: Apium graveolens LeenCelery seed capsules (Apium graveolens L.) 150 mg twice times at day, one capsule with 75 mg before breakfast and one capsule with 75 mg before dinner during 12 weeks. Homologated to the other intervention. Oral administration. | Drug | Celery seed |
| PlaceboAlso: Calcined magnesiaPlacebo capsules (calcined magnesia) twice times at day, one capsule before breakfast and one capsule before dinner during 12 weeks. Homologated to the other intervention. Oral administration. | Drug | Placebo |
Primary outcome
Waist Circumference (WC)
Time frame: Baseline to week 12 (end of intervention)
Waist Circumference will be evaluated at baseline and week 12 by World Health Organization technique
Systolic Blood Pressure (SBP)
Time frame: Baseline to week 12 (end of intervention)
Systolic Blood Pressure (SBP) will be measured at baseline and week 12 with a digital sphygmomanometer three times in each arm to get an average
Diastolic Blood Pressure (DBP)
Time frame: Baseline to week 12 (end of intervention)
Diastolic Blood Pressure (DBP) will be measured at baseline and week 12 with a digital sphygmomanometer three times in each arm to get an average
High-Density Lipoprotein (HDL-c)
Time frame: Baseline to week 12 (end of intervention)
High density lipoprotein (HDL-c) level will be evaluated at baseline and week 12 by enzymatic- colorimetric technique to get c-HDL level
Fasting Blood Triglycerides Concentration (TG)
Time frame: Baseline to week 12 (end of intervention)
Fasting Blood Triglycerides Concentration (TG) level will be evaluated at baseline and week 12 by enzymatic- colorimetric technique to get triglycerides concentration
Fasting Serum Glucose (FSG)
Time frame: Baseline to week 12 (end of intervention)
The Fasting Serum Glucose (FSG) levels will be evaluated at baseline and week 12 by enzymatic- colorimetric technique to get fasting glucose level
Insulin Sensitivity (Matsuda Index)
Time frame: Baseline to week 12 (end of intervention)
Insulin sensitivity will be calculated at baseline and week 12 with Matsuda index to get insulin sensitivity
Total Insulin Secretion
Time frame: Baseline to week 12 (end of intervention)
Total insulin secretion will be calculated at baseline and week 12. It is the result of the ratio between the AUC of insulin in a 2-h OGTT and the AUC of glucose in a 2-h OGTT. It allows estimating the proportion of total insulin secretion in relation to plasma glucose concentration.
First Phase of Insulin Secretion (Stumvoll Index)
Time frame: Baseline to week 12 (end of intervention)
The first phase if insulin secretion will be calculated at baseline and week 12 with Stumvoll index to get first phase of insulin secretion
12 secondary outcomes
Body weight
Time frame: Baseline to week 12 (end of intervention)
Body Mass Index (BMI)
Time frame: Baseline to week 12 (end of intervention)
Body Fat Percentage
Time frame: Baseline to week 12 (end of intervention)
Total Cholesterol (TC)
Time frame: Baseline to week 12 (end of intervention)
Low Density Lipoprotein (LDL-c)
Time frame: Baseline to week 12 (end of intervention)
Very Low Density Lipoprotein (VLDL)
Time frame: Baseline to week 12 (end of intervention)
Concentration of Blood Aspartate Aminostransferase (AST)
Time frame: Baseline to week 12 (end of intervention)
Alanine Aminotransferase (ALT)
Time frame: Baseline to week 12 (end of intervention)
Creatinine
Time frame: Baseline to week 12 (end of intervention)
Uric Acid
Time frame: Baseline to week 12 (end of intervention)
Incidence of treatment-Emergent Adverse Events
Time frame: Baseline to week 12 (end of intervention)
Tolerability to treatment
Time frame: Baseline to week 12 (end of intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Derived from this study: PubMed 41599709Escobedo-Gutierrez MJ, Cortez-Navarrete M, Martinez-Abundis E, Perez-Rubio KG. Effect of Celery Seed (Apium graveolens L.) Administration on the Components of Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion: A Clinical Trial. Pharmaceuticals (Basel). 2026 Jan 7;19(1):110. doi: 10.3390/ph19010110.
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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.
Karina G Pérez Rubio, PhD 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 Phase 2 study testing Celery Seed in people with Metabolic Syndrome, 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 11 inclusion and 8 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 23 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Karina G Pérez Rubio, PhD (+523310585200 ext. 34212, karina2410@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waist Circumference (WC) (time frame: Baseline to week 12 (end of intervention)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06061926, which also lists 1 linked publication.
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 23 Oct 2024.