Metabolic Syndrome
Conditions
Keywords
Insulin Sensitivity, Metabolic Syndrome, Fucoxanthin, Insulin Secretion
Brief summary
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
Detailed description
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
Interventions
DRUGFucoxanthin
Intervention will be administered 30 minutes before breakfast.
DRUGPlacebo
Intervention will be administered 30 minutes before breakfast.
Sponsors
University of Guadalajara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed 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 * \- - - - Blood pressure ≥130/85 mmHg * Body Mass Index between 25 and 34.9 kg/m² * No pharmacological treatment for MS * Stable weight during the last 3 months
Exclusion criteria
* Pregnancy or breast-feeding * History of kidney or liver disease * Drugs or supplements consumption with proven properties that modify the behavior of the MS * Total cholesterol \>240 mg/dL * Triglycerides \>500mg/dL * Glucose ≥126 mg/dL or HbA1C ≥6.5%. * Hypersensitivity to Fucoxanthin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stumvoll Index | 12 weeks. | 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. |
| Waist Circumference (WC) | 12 weeks. | 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. |
| Fasting Serum Glucose | 12 weeks. | Fasting serum glucose concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. |
| Triglycerides (TG) | 12 weeks. | TG concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. |
| High-Density Lipoprotein (HDL-C) | 12 weeks. | Serum HDL-C concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. |
| Systolic Blood Pressure | 12 weeks. | 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. |
| Diastolic Blood Pressure | 12 weeks. | 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. |
| Matsuda-DeFronzo Insulin Sensitivity Index | 12 weeks. | 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. |
| Total Insulin Secretion | 12 weeks. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight | 12 weeks. | Body weight was measured at baseline a bioimpedance scale. |
| Body Mass Index (BMI) | 12 weeks. | BMI was calculated with the Quetelet index formula. |
| Body Fat | 12 weeks. | Percentage of body fat was measured using a bioimpedance scale. |
| Total Cholesterol (TC) | 12 weeks. | Serum Total Cholesterol concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. |
| Low-Density Lipoprotein (LDL-C) | 12 weeks. | Serum LDL-C concentration was calculated using the Friedewald formula (LDL-C = TC - (HDL-C + \[TG/5\]) |
| Very-Low-Density Lipoprotein (VLDL) | 12 weeks. | Serum VLDL concentration was calculated with the formula: VLDL-C = TG/5. |
| Alanine Aminotransferase (ALT) | 12 weeks. | Serum ALT concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. |
| Aspartate Aminotransferase (AST) | 12 weeks. | Serum AST concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. |
| Creatinin | 12 weeks. | Serum creatinin concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fucoxanthin Received one (1) 12 mg fucoxanthin capsule, once a day. | 14 |
| Placebo Received one (1) magnesium stearate capsule, once a day. | 14 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Fucoxanthin | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 49.3 years STANDARD_DEVIATION 7.8 | 47.4 years STANDARD_DEVIATION 8.5 | 45.6 years STANDARD_DEVIATION 9.1 |
| Alanine Aminotransferase | 0.45 ukat/L STANDARD_DEVIATION 0.29 | 0.49 ukat/L STANDARD_DEVIATION 0.3 | 0.53 ukat/L STANDARD_DEVIATION 0.32 |
| Aspartate Aminotransferase | 0.39 ukat/L STANDARD_DEVIATION 0.31 | 0.40 ukat/L STANDARD_DEVIATION 0.28 | 0.40 ukat/L STANDARD_DEVIATION 0.26 |
| Body Fat | 34.6 Percentage STANDARD_DEVIATION 8.6 | 34.4 Percentage STANDARD_DEVIATION 7.6 | 34.3 Percentage STANDARD_DEVIATION 6.8 |
| Body Mass Index (BMI) | 31.1 kg/m^2 STANDARD_DEVIATION 3.6 | 30.9 kg/m^2 STANDARD_DEVIATION 3 | 30.7 kg/m^2 STANDARD_DEVIATION 2.3 |
| Body Weight | 80.6 kg STANDARD_DEVIATION 11.2 | 80.7 kg STANDARD_DEVIATION 9.8 | 80.9 kg STANDARD_DEVIATION 8.6 |
| Creatinin | 78.4 µmol/L STANDARD_DEVIATION 23.6 | 82.6 µmol/L STANDARD_DEVIATION 28.3 | 86.9 µmol/L STANDARD_DEVIATION 32.6 |
| Diastolic Blood Pressure | 81.5 mmHg STANDARD_DEVIATION 6.5 | 80.9 mmHg STANDARD_DEVIATION 7.6 | 80.3 mmHg STANDARD_DEVIATION 8.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 28 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fasting Serum Glucose | 5.5 mmol/L STANDARD_DEVIATION 0.6 | 5.6 mmol/L STANDARD_DEVIATION 0.5 | 5.7 mmol/L STANDARD_DEVIATION 0.5 |
| High-Density Lipoprotein (HDL-C) | 1.2 mmol/L STANDARD_DEVIATION 0.3 | 1.2 mmol/L STANDARD_DEVIATION 0.2 | 1.2 mmol/L STANDARD_DEVIATION 0.2 |
| Low-Density lipoprotein (LDL-C) | 3.1 mmol/L STANDARD_DEVIATION 1 | 2.9 mmol/L STANDARD_DEVIATION 1 | 2.67 mmol/L STANDARD_DEVIATION 0.9 |
| Matsuda-DeFronzo insulin sensitivity index | 2.07 Index STANDARD_DEVIATION 0.74 | 2.10 Index STANDARD_DEVIATION 0.92 | 2.12 Index STANDARD_DEVIATION 1.1 |
| Region of Enrollment Mexico | 14 participants | 28 participants | 14 participants |
| Sex: Female, Male Female | 7 Participants | 12 Participants | 5 Participants |
| Sex: Female, Male Male | 7 Participants | 16 Participants | 9 Participants |
| Stumvoll index | 2403 Index STANDARD_DEVIATION 621 | 2279 Index STANDARD_DEVIATION 660 | 2155 Index STANDARD_DEVIATION 698 |
| Systolic Blood Pressure | 126.1 mmHg STANDARD_DEVIATION 10.3 | 124.1 mmHg STANDARD_DEVIATION 13.3 | 120.8 mmHg STANDARD_DEVIATION 15.7 |
| Total Cholesterol | 5.3 mmol/L STANDARD_DEVIATION 1 | 5.1 mmol/L STANDARD_DEVIATION 1 | 5.0 mmol/L STANDARD_DEVIATION 0.9 |
| Total Insulin Secretion | 0.84 Ratio STANDARD_DEVIATION 0.31 | 0.82 Ratio STANDARD_DEVIATION 0.27 | 0.80 Ratio STANDARD_DEVIATION 0.21 |
| Triglycerides | 2.2 mmol/L STANDARD_DEVIATION 0.7 | 2.3 mmol/L STANDARD_DEVIATION 0.9 | 2.4 mmol/L STANDARD_DEVIATION 1 |
| Very-Low-Density Lipoprotein (VLDL) | 1.0 mmol/L STANDARD_DEVIATION 0.3 | 1.0 mmol/L STANDARD_DEVIATION 0.5 | 1.1 mmol/L STANDARD_DEVIATION 0.5 |
| Waist Circumference | 101.2 cm STANDARD_DEVIATION 9.1 | 101.7 cm STANDARD_DEVIATION 7.2 | 102.1 cm STANDARD_DEVIATION 5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 5 / 14 | 5 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
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.
Time frame: 12 weeks.
Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fucoxanthin | Diastolic Blood Pressure | 78.6 mmHg | Standard Deviation 6.3 |
| Placebo | Diastolic Blood Pressure | 79.2 mmHg | Standard Deviation 7.4 |
Primary
Fasting Serum Glucose
Fasting serum glucose concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.
Time frame: 12 weeks.
Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fucoxanthin | Fasting Serum Glucose | 5.5 mmol/L | Standard Deviation 0.6 |
| Placebo | Fasting Serum Glucose | 5.6 mmol/L | Standard Deviation 0.5 |
Primary
High-Density Lipoprotein (HDL-C)
Serum HDL-C concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.
Time frame: 12 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fucoxanthin | High-Density Lipoprotein (HDL-C) | 1.2 mmol/L | Standard Deviation 0.2 |
| Placebo | High-Density Lipoprotein (HDL-C) | 1.2 mmol/L | Standard Deviation 0.2 |
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.
Time frame: 12 weeks.
Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fucoxanthin | Matsuda-DeFronzo Insulin Sensitivity Index | 2.19 index | Standard Deviation 0.9 |
| Placebo | Matsuda-DeFronzo Insulin Sensitivity Index | 2.19 index | Standard Deviation 1.07 |
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.
Time frame: 12 weeks.
Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fucoxanthin | Stumvoll Index | 2907 index | Standard Deviation 732 |
| Placebo | Stumvoll Index | 2298 index | Standard Deviation 446 |
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.
Time frame: 12 weeks.
Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fucoxanthin | Systolic Blood Pressure | 120.8 mmHg | Standard Deviation 9.7 |
| Placebo | Systolic Blood Pressure | 119.1 mmHg | Standard Deviation 14.5 |
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.
Time frame: 12 weeks.
Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fucoxanthin | Total Insulin Secretion | 1.02 Ratio | Standard Deviation 0.32 |
| Placebo | Total Insulin Secretion | 0.85 Ratio | Standard Deviation 0.23 |
Primary
Triglycerides (TG)
TG concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.
Time frame: 12 weeks.
Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fucoxanthin | Triglycerides (TG) | 2.1 mmol/L | Standard Deviation 0.7 |
| Placebo | Triglycerides (TG) | 2.4 mmol/L | Standard Deviation 0.9 |
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.
Time frame: 12 weeks.
Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fucoxanthin | Waist Circumference (WC) | 98.9 cm | Standard Deviation 9.3 |
| Placebo | Waist Circumference (WC) | 102.1 cm | Standard Deviation 5.6 |
Secondary
Alanine Aminotransferase (ALT)
Serum ALT concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.
Time frame: 12 weeks.
Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fucoxanthin | Alanine Aminotransferase (ALT) | 0.47 ukat/L | Standard Deviation 0.24 |
| Placebo | Alanine Aminotransferase (ALT) | 0.50 ukat/L | Standard Deviation 0.29 |
Secondary
Aspartate Aminotransferase (AST)
Serum AST concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.
Time frame: 12 weeks.
Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fucoxanthin | Aspartate Aminotransferase (AST) | 0.41 ukat/L | Standard Deviation 0.28 |
| Placebo | Aspartate Aminotransferase (AST) | 0.42 ukat/L | Standard Deviation 0.26 |
Secondary
Body Fat
Percentage of body fat was measured using a bioimpedance scale.
Time frame: 12 weeks.
Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fucoxanthin | Body Fat | 33.0 percentage | Standard Deviation 8.3 |
| Placebo | Body Fat | 34.9 percentage | Standard Deviation 7.4 |
Secondary
Body Mass Index (BMI)
BMI was calculated with the Quetelet index formula.
Time frame: 12 weeks.
Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fucoxanthin | Body Mass Index (BMI) | 30.3 kg/m^2 | Standard Deviation 3.7 |
| Placebo | Body Mass Index (BMI) | 31.0 kg/m^2 | Standard Deviation 2.1 |
Secondary
Body Weight
Body weight was measured at baseline a bioimpedance scale.
Time frame: 12 weeks.
Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fucoxanthin | Body Weight | 79.16 kg | Standard Deviation 12.3 |
| Placebo | Body Weight | 82.1 kg | Standard Deviation 7.9 |
Secondary
Creatinin
Serum creatinin concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.
Time frame: 12 weeks.
Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fucoxanthin | Creatinin | 83.8 µmol/L | Standard Deviation 21.7 |
| Placebo | Creatinin | 76.4 µmol/L | Standard Deviation 26.4 |
Secondary
Low-Density Lipoprotein (LDL-C)
Serum LDL-C concentration was calculated using the Friedewald formula (LDL-C = TC - (HDL-C + \[TG/5\])
Time frame: 12 weeks.
Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fucoxanthin | Low-Density Lipoprotein (LDL-C) | 3.0 mmol/L | Standard Error 0.9 |
| Placebo | Low-Density Lipoprotein (LDL-C) | 2.7 mmol/L | Standard Error 1 |
Secondary
Total Cholesterol (TC)
Serum Total Cholesterol concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.
Time frame: 12 weeks.
Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fucoxanthin | Total Cholesterol (TC) | 5.1 mmol/L | Standard Deviation 1 |
| Placebo | Total Cholesterol (TC) | 4.9 mmol/L | Standard Deviation 1 |
Secondary
Very-Low-Density Lipoprotein (VLDL)
Serum VLDL concentration was calculated with the formula: VLDL-C = TG/5.
Time frame: 12 weeks.
Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fucoxanthin | Very-Low-Density Lipoprotein (VLDL) | 0.9 mmol/L | Standard Deviation 0.3 |
| Placebo | Very-Low-Density Lipoprotein (VLDL) | 1.1 mmol/L | Standard Deviation 0.4 |