Trial · NCT03613740
Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
NCT03613740, Phase 2, Completed, University of Guadalajara; results first posted 2024-11-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion. Trials, record NCT03613740. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03613740
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
- NCT number
- NCT03613740
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- University of Guadalajara
- Conditions
- Metabolic Syndrome
- Interventions
- Fucoxanthin, Placebo
- First posted
- 2018-08-03
- Last updated
- 2024-11-21
- Results first posted
- 2024-11-21
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | Fasting Serum Glucose | 12 weeks. | Fasting serum glucose concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. |
| Primary | Triglycerides (TG) | 12 weeks. | TG concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. |
| Primary | High-Density Lipoprotein (HDL-C) | 12 weeks. | Serum HDL-C concentration was measured with enzymatic/colorimetric techniques by spectrophotometry. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Secondary | Body Weight | 12 weeks. | Body weight was measured at baseline a bioimpedance scale. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Waist Circumference (WC) | 12 weeks. | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | cm | MEAN |
| PRIMARY | Fasting Serum Glucose | 12 weeks. | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | mmol/L | MEAN |
| PRIMARY | Triglycerides (TG) | 12 weeks. | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | mmol/L | MEAN |
| PRIMARY | High-Density Lipoprotein (HDL-C) | 12 weeks. | mmol/L | MEAN | |
| PRIMARY | Systolic Blood Pressure | 12 weeks. | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | mmHg | MEAN |
| PRIMARY | Diastolic Blood Pressure | 12 weeks. | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | mmHg | MEAN |
| PRIMARY | Matsuda-DeFronzo Insulin Sensitivity Index | 12 weeks. | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | index | MEAN |
| PRIMARY | Total Insulin Secretion | 12 weeks. | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | Ratio | MEAN |
| PRIMARY | Stumvoll Index | 12 weeks. | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | index | MEAN |
| SECONDARY | Body Weight | 12 weeks. | All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat) | kg | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Waist Circumference (WC) | Fucoxanthin | 98.9 | Standard Deviation 9.3 | cm | |
| Waist Circumference (WC) | Placebo | 102.1 | Standard Deviation 5.6 | cm | |
| Fasting Serum Glucose | Fucoxanthin | 5.5 | Standard Deviation 0.6 | mmol/L | |
| Fasting Serum Glucose | Placebo | 5.6 | Standard Deviation 0.5 | mmol/L | |
| Triglycerides (TG) | Fucoxanthin | 2.1 | Standard Deviation 0.7 | mmol/L | |
| Triglycerides (TG) | Placebo | 2.4 | Standard Deviation 0.9 | mmol/L | |
| High-Density Lipoprotein (HDL-C) | Fucoxanthin | 1.2 | Standard Deviation 0.2 | mmol/L | |
| High-Density Lipoprotein (HDL-C) | Placebo | 1.2 | Standard Deviation 0.2 | mmol/L | |
| Systolic Blood Pressure | Fucoxanthin | 120.8 | Standard Deviation 9.7 | mmHg | |
| Systolic Blood Pressure | Placebo | 119.1 | Standard Deviation 14.5 | mmHg |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fucoxanthin | 14 | |
| Overall Study | STARTED | Placebo | 14 | |
| Overall Study | COMPLETED | Fucoxanthin | 13 | |
| Overall Study | COMPLETED | Placebo | 13 | |
| Overall Study | NOT COMPLETED | Fucoxanthin | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Frequent bowel movements | Gastrointestinal disorders | Fucoxanthin | 4 | 14 | 4 |
| other | Frequent bowel movements | Gastrointestinal disorders | Placebo | 3 | 14 | 3 |
| other | Flatulence | Gastrointestinal disorders | Fucoxanthin | 3 | 14 | 3 |
| other | Flatulence | Gastrointestinal disorders | Placebo | 2 | 14 | 2 |
| other | Headache | Nervous system disorders | Fucoxanthin | 2 | 14 | 2 |
| other | Headache | Nervous system disorders | Placebo | 1 | 14 | 1 |
| other | Fatigue | General disorders | Fucoxanthin | 0 | 14 | 0 |
| other | Fatigue | General disorders | Placebo | 1 | 14 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fucoxanthin | 0 | 14 |
| Total, all-cause mortality | Placebo | 0 | 14 |
| Total, other adverse events | Fucoxanthin | 5 | 14 |
| Total, other adverse events | Placebo | 5 | 14 |
| Total, serious adverse events | Fucoxanthin | 0 | 14 |
| Total, serious adverse events | Placebo | 0 | 14 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Fucoxanthin vs Placebo: deaths from any cause | Trial comparisons |
| Fucoxanthin vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03613740
GET https://conductscience.org/api/trials/v1/NCT03613740/results?page=2