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The Metabolic Syndrome (MS) is a cluster of cardiometabolic risk factors, which include abdominal obesity, hyperglycemia, dyslipidemia, and high blood pressure. MS is considered a serious problem to health systems due to a current inability on implementing an effective prevention and treatment program. In Mexico 73% of adult population suffers obesity or overweight, this condition triggers the best studied pathophysiological mechanism; insulin resistance, which in turn precedes the diagnosis of diabetes and cardiovascular disease, that are the main cause of general mortality in Mexico, thus the prevention and timely treatment of this condition are now a priority.
Actual pharmacological therapy is designed to control its components individually, however, there are great interest in developing new therapeutic lines that improve more than one component simultaneously and thereby increase the cost-benefit and effectiveness of the therapy. Fucoxanthin is a functional element present in seaweed species. Several studies have offered certain perspectives on its action mechanism and safety. The information available is favorable for weight control in overweight subjects, but its activity in glucose levels, lipid metabolism and blood pressure is inconsistent. It represents a natural option with great interest in this research, since it could be a new, safe and effective therapy in the MS.
The aim of this study is to evaluate the effect of fucoxanthin on the components of the MS, insulin sensitivity and insulin secretion. The investigators hypothesis is that Fucoxanthin modifies the components of the MS, insulin sensitivity and insulin secretion
A randomized, double-blind, placebo-controlled, clinical trial will be conducted in 28 patients with MS according to the International Diabetes Federation (IDF) criteria, men and women, ages 30 to 60. Participants will be assigned randomly into two groups of 14 individuals each. Patients will receive a capsule with Fucoxanthin 12 mg or homologated placebo once a day during 90 days.
Waist circumference, fasting blood glucose, serum triglycerides, serum HDL cholesterol and blood pressure will be evaluated before and after intervention in both groups. First phase of insulin secretion (Stumvoll index), total insulin secretion (Insulinogenic index) and Insulin sensitivity (Matsuda index) will be calculated from the concentration of glucose and insulin obtained from an Oral Glucose Tolerance Test.
Data from statistical analysis will be presented through measures of central tendency and dispersion( mean and standard deviation) for quantitative variables and frequencies and percentages for qualitative variables. The qualitative variables will be analyzed through the X2 or Fisher's exact test. The intra-group analysis of the quantitative variables will be carried out by means of the Wilcoxon rank test, while the inter-group analysis with the U test of Mann Whitney and Kruskal-Wallis. Statistical significance will be considered with a p<0.05.
This protocol was approved by a local ethics committee and written informed consent will be obtained from all volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fucoxanthin | Experimental | 12 mg Fucoxanthin capsule, once a day before breakfast during 90 days. |
|
| Placebo | Placebo Comparator | Homologated magnesium sterate capsule, once a day before breakfast during 90 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fucoxanthin | Drug | Intervention will be administered 30 minutes before breakfast. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Waist Circumference (WC) | WC was measured with a flexible tape at the midline between the highest point of the iliac crest and the lowest rib in the midaxillary line. | 12 weeks. |
| Fasting Serum Glucose | Fasting serum glucose concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. | 12 weeks. |
| Triglycerides (TG) | TG concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. | 12 weeks. |
| High-Density Lipoprotein (HDL-C) | Serum HDL-C concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. | 12 weeks. |
| Systolic Blood Pressure | Blood pressure was evaluated using a digital sphygmomanometer after a resting period of 15 min with the subject sitting; the bracelet was adjusted 3.0 cm above the fold of the elbow of the left arm. | 12 weeks. |
| Diastolic Blood Pressure | Blood pressure was evaluated using a digital sphygmomanometer after a resting period of 15 min with the subject sitting; the bracelet was adjusted 3.0 cm above the fold of the elbow of the left arm. | 12 weeks. |
| Matsuda-DeFronzo Insulin Sensitivity Index | The Matsuda-DeFronzo index measures whole-body insulin sensitivity from serum insulin and glucose levels during an oral glucose tolerance test (OGTT). The index is calculated with the formula: 10,000 / sqrt([fasting glucose (mg/dL) × fasting insulin (µU/mL)] × [mean glucose × mean insulin during OGTT]). The scale ranges from 0 to infinity, with higher values indicating greater insulin sensitivity. Typical values for healthy individuals range between 2 and 10, while lower values suggest insulin resistance. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Body weight was measured at baseline a bioimpedance scale. | 12 weeks. |
| Body Mass Index (BMI) | BMI was calculated with the Quetelet index formula. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manuel Gonzalez Ortiz, MD MSc Phd | University of Guadalajara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara | Guadalajara | Jalisco | 44340 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37405785 | Result | Lopez-Ramos A, Gonzalez-Ortiz M, Martinez-Abundis E, Perez-Rubio KG. Effect of Fucoxanthin on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion. J Med Food. 2023 Jul;26(7):521-527. doi: 10.1089/jmf.2022.0103. Epub 2023 Jul 4. | |
| 33993853 | Derived | Yang M, Xuan Z, Wang Q, Yan S, Zhou D, Naman CB, Zhang J, He S, Yan X, Cui W. Fucoxanthin has potential for therapeutic efficacy in neurodegenerative disorders by acting on multiple targets. Nutr Neurosci. 2022 Oct;25(10):2167-2180. doi: 10.1080/1028415X.2021.1926140. Epub 2021 May 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fucoxanthin | Received one (1) 12 mg fucoxanthin capsule, once a day. |
| FG001 | Placebo | Received one (1) Magnesium stearate capsule, once a day |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fucoxanthin | Received one (1) 12 mg fucoxanthin capsule, once a day. |
| BG001 | Placebo | Received one (1) magnesium stearate capsule, once a day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Waist Circumference (WC) | WC was measured with a flexible tape at the midline between the highest point of the iliac crest and the lowest rib in the midaxillary line. | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | cm | 12 weeks. |
|
12 weeks.
Adverse event and serious adverse event definition does not differ from the clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fucoxanthin | 12 mg Fucoxanthin capsule, once a day before breakfast during 90 days. Fucoxanthin: Intervention will be administered 30 minutes before breakfast. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PhD. Karina G. Pérez Rubio | University of Guadalajara | +52 1 3310585200 | karina.prubio@academicos.udg.mx |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 1, 2019 | Sep 25, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C025164 | fucoxanthin |
| C031183 | stearic acid |
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Parallel Assignment
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| Placebo |
| Drug |
Intervention will be administered 30 minutes before breakfast. |
|
|
| 12 weeks. |
| Total Insulin Secretion | The Total Insulin Secretion is calculated as the ratio of the area under the curve (AUC) for insulin to the AUC for glucose during a 120-minute oral glucose tolerance test (OGTT). The formula is: AUC insulin / AUC glucose. AUC values are derived from concentrations measured at 0, 30, 60, 90, and 120 minutes post-ingestion of a glucose solution at week 12. Interpretation of the AUC insulin/AUC glucose ratio is as follows: values <0.5 indicate insulin resistance, values between 0.5 and 1.0 suggest moderate insulin secretion, and values >1.0 reflect optimal insulin secretion. | 12 weeks. |
| Stumvoll Index | The Stumvoll index measures the first phase of insulin secretion, incorporates demographic data along with plasma glucose (mmol/L) and insulin (pmol/L) levels measured during an oral glucose tolerance test (OGTT). There is no universally standardized ranges, values ranges from 0 to infinity; higher values indicate a better early insulin response to glucose (first 30 minutes), reflecting more effective beta-cell function. | 12 weeks. |
| 12 weeks. |
| Body Fat | Percentage of body fat was measured using a bioimpedance scale. | 12 weeks. |
| Total Cholesterol (TC) | Serum Total Cholesterol concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. | 12 weeks. |
| Low-Density Lipoprotein (LDL-C) | Serum LDL-C concentration was calculated using the Friedewald formula (LDL-C = TC - (HDL-C + [TG/5]) | 12 weeks. |
| Very-Low-Density Lipoprotein (VLDL) | Serum VLDL concentration was calculated with the formula: VLDL-C = TG/5. | 12 weeks. |
| Alanine Aminotransferase (ALT) | Serum ALT concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. | 12 weeks. |
| Aspartate Aminotransferase (AST) | Serum AST concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. | 12 weeks. |
| Creatinin | Serum creatinin concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. | 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Waist Circumference | Mean | Standard Deviation | cm |
|
| Body Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Body Fat | Mean | Standard Deviation | Percentage |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Fasting Serum Glucose | Mean | Standard Deviation | mmol/L |
|
| Triglycerides | Mean | Standard Deviation | mmol/L |
|
| Total Cholesterol | Mean | Standard Deviation | mmol/L |
|
| High-Density Lipoprotein (HDL-C) | Mean | Standard Deviation | mmol/L |
|
| Low-Density lipoprotein (LDL-C) | Mean | Standard Deviation | mmol/L |
|
| Very-Low-Density Lipoprotein (VLDL) | Mean | Standard Deviation | mmol/L |
|
| Matsuda-DeFronzo insulin sensitivity index | The Matsuda-DeFronzo index measures whole-body insulin sensitivity from serum insulin and glucose levels during an oral glucose tolerance test (OGTT). The index is calculated with the formula: 10,000 / sqrt([fasting glucose (mg/dL) × fasting insulin (µU/mL)] × [mean glucose × mean insulin during OGTT]). The scale ranges from 0 to infinity, with higher values indicating greater insulin sensitivity. Typical values for healthy individuals range between 2 and 10, while lower values suggest insulin resistance. | Mean | Standard Deviation | Index |
|
| Stumvoll index | The Stumvoll index measures the first phase of insulin secretion, incorporates demographic data along with plasma glucose (mmol/L) and insulin (pmol/L) levels measured during an oral glucose tolerance test (OGTT). There is no universally standardized ranges, values ranges from 0 to infinity; higher values indicate a better early insulin response to glucose (first 30 minutes), reflecting more effective beta-cell function. | Mean | Standard Deviation | Index |
|
| Total Insulin Secretion | The Total Insulin Secretion is calculated as the ratio of the area under the curve (AUC) for insulin to the AUC for glucose during a 120-minute oral glucose tolerance test (OGTT). The formula is: AUC insulin / AUC glucose. AUC values are derived from concentrations measured at 0, 30, 60, 90, and 120 minutes post-ingestion of a glucose solution at baseline day. Interpretation of the AUC insulin/AUC glucose ratio is as follows: values <0.5 indicate insulin resistance, values between 0.5 and 1.0 suggest moderate insulin secretion, and values >1.0 reflect optimal insulin secretion. | Mean | Standard Deviation | Ratio |
|
| Alanine Aminotransferase | Mean | Standard Deviation | ukat/L |
|
| Aspartate Aminotransferase | Mean | Standard Deviation | ukat/L |
|
| Creatinin | Mean | Standard Deviation | µmol/L |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Fasting Serum Glucose | Fasting serum glucose concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | mmol/L | 12 weeks. |
|
|
|
| Primary | Triglycerides (TG) | TG concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | mmol/L | 12 weeks. |
|
|
|
| Primary | High-Density Lipoprotein (HDL-C) | Serum HDL-C concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. | Posted | Mean | Standard Deviation | mmol/L | 12 weeks. |
|
|
|
| Primary | Systolic Blood Pressure | Blood pressure was evaluated using a digital sphygmomanometer after a resting period of 15 min with the subject sitting; the bracelet was adjusted 3.0 cm above the fold of the elbow of the left arm. | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | mmHg | 12 weeks. |
|
|
|
| Primary | Diastolic Blood Pressure | Blood pressure was evaluated using a digital sphygmomanometer after a resting period of 15 min with the subject sitting; the bracelet was adjusted 3.0 cm above the fold of the elbow of the left arm. | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | mmHg | 12 weeks. |
|
|
|
| Primary | Matsuda-DeFronzo Insulin Sensitivity Index | The Matsuda-DeFronzo index measures whole-body insulin sensitivity from serum insulin and glucose levels during an oral glucose tolerance test (OGTT). The index is calculated with the formula: 10,000 / sqrt([fasting glucose (mg/dL) × fasting insulin (µU/mL)] × [mean glucose × mean insulin during OGTT]). The scale ranges from 0 to infinity, with higher values indicating greater insulin sensitivity. Typical values for healthy individuals range between 2 and 10, while lower values suggest insulin resistance. | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | index | 12 weeks. |
|
|
|
| Primary | Total Insulin Secretion | The Total Insulin Secretion is calculated as the ratio of the area under the curve (AUC) for insulin to the AUC for glucose during a 120-minute oral glucose tolerance test (OGTT). The formula is: AUC insulin / AUC glucose. AUC values are derived from concentrations measured at 0, 30, 60, 90, and 120 minutes post-ingestion of a glucose solution at week 12. Interpretation of the AUC insulin/AUC glucose ratio is as follows: values <0.5 indicate insulin resistance, values between 0.5 and 1.0 suggest moderate insulin secretion, and values >1.0 reflect optimal insulin secretion. | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | Ratio | 12 weeks. |
|
|
|
| Primary | Stumvoll Index | The Stumvoll index measures the first phase of insulin secretion, incorporates demographic data along with plasma glucose (mmol/L) and insulin (pmol/L) levels measured during an oral glucose tolerance test (OGTT). There is no universally standardized ranges, values ranges from 0 to infinity; higher values indicate a better early insulin response to glucose (first 30 minutes), reflecting more effective beta-cell function. | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | index | 12 weeks. |
|
|
|
| Secondary | Body Weight | Body weight was measured at baseline a bioimpedance scale. | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | kg | 12 weeks. |
|
|
|
| Secondary | Body Mass Index (BMI) | BMI was calculated with the Quetelet index formula. | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | kg/m^2 | 12 weeks. |
|
|
|
| Secondary | Body Fat | Percentage of body fat was measured using a bioimpedance scale. | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | percentage | 12 weeks. |
|
|
|
| Secondary | Total Cholesterol (TC) | Serum Total Cholesterol concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | mmol/L | 12 weeks. |
|
|
|
| Secondary | Low-Density Lipoprotein (LDL-C) | Serum LDL-C concentration was calculated using the Friedewald formula (LDL-C = TC - (HDL-C + [TG/5]) | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Error | mmol/L | 12 weeks. |
|
|
|
| Secondary | Very-Low-Density Lipoprotein (VLDL) | Serum VLDL concentration was calculated with the formula: VLDL-C = TG/5. | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | mmol/L | 12 weeks. |
|
|
|
| Secondary | Alanine Aminotransferase (ALT) | Serum ALT concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | ukat/L | 12 weeks. |
|
|
|
| Secondary | Aspartate Aminotransferase (AST) | Serum AST concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | ukat/L | 12 weeks. |
|
|
|
| Secondary | Creatinin | Serum creatinin concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | µmol/L | 12 weeks. |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 5 |
| 14 |
| EG001 | Placebo | Homologated magnesium sterate capsule, once a day before breakfast during 90 days. Placebo: Intervention will be administered 30 minutes before breakfast. | 0 | 14 | 0 | 14 | 5 | 14 |
| Flatulence | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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