Metabolic SyndromePhase 2NCT03613740

Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

A Phase 2 study testing Fucoxanthin in people with Metabolic Syndrome, run by University of Guadalajara at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 60 years
Conditions the study is for: Metabolic Syndrome
What is being tested?: Fucoxanthin
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: 30 Sep 2019to 30 Jul 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

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

Show all 9Show fewer

Body Mass Index between 25 and 34.9 kg/m²
No pharmacological treatment for MS
Stable weight during the last 3 months

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, 44340

Other trials in Mexico

About this study

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

Read the 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

Conditions: Metabolic Syndrome
Being tested: Fucoxanthin, Placebo
Keywords: Insulin Sensitivity, Metabolic Syndrome, Fucoxanthin, Insulin Secretion
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.

FucoxanthinDrug
Intervention will be administered 30 minutes before breakfast.
PlaceboDrug
Also called Magnesium Sterate
Intervention will be administered 30 minutes before breakfast.

Study groups in NCT03613740
Study group	Role	What they receive
Fucoxanthin	Experimental	12 mg Fucoxanthin capsule, once a day before breakfast during 90 days. Receives: Drug: Fucoxanthin
Placebo	Placebo comparator	Homologated magnesium sterate capsule, once a day before breakfast during 90 days. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 weeks.
Fasting Serum Glucose
Fasting serum glucose concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.
Measured: 12 weeks.
Triglycerides (TG)
TG concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.
Measured: 12 weeks.
High-Density Lipoprotein (HDL-C)
Serum HDL-C concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks.

Secondary outcomes (9)

Body Weight
Body weight was measured at baseline a bioimpedance scale.
Measured: 12 weeks.
Body Mass Index (BMI)
BMI was calculated with the Quetelet index formula.
Measured: 12 weeks.
Body Fat
Percentage of body fat was measured using a bioimpedance scale.
Measured: 12 weeks.
Total Cholesterol (TC)
Serum Total Cholesterol concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.
Measured: 12 weeks.
Low-Density Lipoprotein (LDL-C)
Serum LDL-C concentration was calculated using the Friedewald formula (LDL-C = TC - (HDL-C + [TG/5])
Measured: 12 weeks.
Very-Low-Density Lipoprotein (VLDL)
Serum VLDL concentration was calculated with the formula: VLDL-C = TG/5.
Measured: 12 weeks.
Alanine Aminotransferase (ALT)
Serum ALT concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.
Measured: 12 weeks.
Aspartate Aminotransferase (AST)
Serum AST concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.
Measured: 12 weeks.
Creatinin
Serum creatinin concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.
Measured: 12 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 201930 Jul 2023

First posted3 Aug 2018
Study start30 Sep 2019
Primary completion30 Jan 2022
Study completion30 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)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: Parallel Assignment
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03613740
Sponsor's protocol ID: Fucoxanthin-MS
Status last verified: Sep 2024
First submitted: 19 Jul 2018
Last updated: 21 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 37405785
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.
PubMed 33993853

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metabolic Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
ClinicalTrials.gov ID: NCT03613740
Acronym / sponsor ID: Fucoxanthin-MS
Conditions: Metabolic Syndrome
Keywords: Insulin Sensitivity, Metabolic Syndrome, Fucoxanthin, Insulin Secretion
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: University of GuadalajaraUniversity, hospital or other
Study start: 30 Sep 2019 (actual)
Primary completion: 30 Jan 2022 (actual)
Study completion: 30 Jul 2023 (actual)
First posted: 3 Aug 2018 (actual)
Results: Posted 21 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This protocol was approved by a local ethics committee and written informed consent will be obtained from all volunteers

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Parallel Assignment

Arm	Type	Receives
Fucoxanthin	Experimental	Drug: Fucoxanthin12 mg Fucoxanthin capsule, once a day before breakfast during 90 days.
Placebo	Placebo comparator	Drug: PlaceboHomologated magnesium sterate capsule, once a day before breakfast during 90 days.

Who may qualify

Ages: 30 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (7 listed)

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

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
FucoxanthinIntervention will be administered 30 minutes before breakfast.	Drug	Fucoxanthin
PlaceboAlso: Magnesium SterateIntervention will be administered 30 minutes before breakfast.	Drug	Placebo

Primary outcome

Waist Circumference (WC)
Time frame: 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
Time frame: 12 weeks.
Fasting serum glucose concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.
Triglycerides (TG)
Time frame: 12 weeks.
TG concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.
High-Density Lipoprotein (HDL-C)
Time frame: 12 weeks.
Serum HDL-C concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.
Systolic Blood Pressure
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Stumvoll Index
Time frame: 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.

9 secondary outcomes

Body Weight
Time frame: 12 weeks.
Body Mass Index (BMI)
Time frame: 12 weeks.
Body Fat
Time frame: 12 weeks.
Total Cholesterol (TC)
Time frame: 12 weeks.
Low-Density Lipoprotein (LDL-C)
Time frame: 12 weeks.
Very-Low-Density Lipoprotein (VLDL)
Time frame: 12 weeks.
Alanine Aminotransferase (ALT)
Time frame: 12 weeks.
Aspartate Aminotransferase (AST)
Time frame: 12 weeks.
Creatinin
Time frame: 12 weeks.

Results and safety

Results posted to the registry on 21 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fucoxanthin	14	13
Placebo	14	13

Primary outcome: Waist Circumference (WC)

Time frame: 12 weeks.. Mean (Standard Deviation). Unit: cm

Measure	Fucoxanthin n = 13	Placebo n = 13
Value	98.9 (9.3)	102.1 (5.6)

Population analysed: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

Primary outcome: Fasting Serum Glucose

Time frame: 12 weeks.. Mean (Standard Deviation). Unit: mmol/L

Measure	Fucoxanthin n = 13	Placebo n = 13
Value	5.5 (0.6)	5.6 (0.5)

Population analysed: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)

Primary outcome: Triglycerides (TG)

Time frame: 12 weeks.. Mean (Standard Deviation). Unit: mmol/L

Measure	Fucoxanthin n = 13	Placebo n = 13
Value	2.1 (0.7)	2.4 (0.9)

Population analysed: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)

Primary outcome: High-Density Lipoprotein (HDL-C)

Time frame: 12 weeks.. Mean (Standard Deviation). Unit: mmol/L

Measure	Fucoxanthin n = 13	Placebo n = 13
Value	1.2 (0.2)	1.2 (0.2)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fucoxanthin	0 of 14 (0%)	5 of 14 (35.7%)	0 of 14
Placebo	0 of 14 (0%)	5 of 14 (35.7%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 37405785Lopez-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.
Derived from this study: PubMed 33993853Yang 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.
Individual participant dataSharing planned: No

Related trials for Metabolic Syndrome

RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
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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.

Manuel Gonzalez Ortiz, MD MSc 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 Fucoxanthin 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 9 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: finished, as of the sponsor's last update on 21 Nov 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?

Yes. Results are posted in the registry (first posted 21 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Waist Circumference (WC) (time frame: 12 weeks.). 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 NCT03613740, which also lists 2 linked publications.

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 21 Nov 2024.