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

NCT ID: NCT03613740

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2023-07-30

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

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fucoxanthin

12 mg Fucoxanthin capsule, once a day before breakfast during 90 days.

Group Type: EXPERIMENTAL

Fucoxanthin

Intervention Type: DRUG

Intervention will be administered 30 minutes before breakfast.

Placebo

Homologated magnesium sterate capsule, once a day before breakfast during 90 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intervention will be administered 30 minutes before breakfast.

Interventions

Fucoxanthin

Intervention will be administered 30 minutes before breakfast.

Intervention Type: DRUG

Placebo

Intervention will be administered 30 minutes before breakfast.

Intervention Type: DRUG

Other Intervention Names

Magnesium Sterate

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Karina Griselda Pérez Rubio

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manuel Gonzalez Ortiz, MD MSc Phd

Role: PRINCIPAL_INVESTIGATOR

University of Guadalajara

Locations

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

Guadalajara, Jalisco, Mexico

Countries

Mexico

References

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.

Reference Type: RESULT

PMID: 37405785 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33993853 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

Fucoxanthin-MS

Identifier Type: -

Identifier Source: org_study_id