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

NCT03613740 | Completed Phase 2 Results

• 1 other identifier: Fucoxanthin-MS
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Metabolic Syndrome

Keywords

Insulin Sensitivity; Metabolic Syndrome; Fucoxanthin; Insulin Secretion

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

Secondary Outcomes (9)

• Body Weight

  12 weeks.

• Body Mass Index (BMI)

  12 weeks.

• Body Fat

  12 weeks.

• Total Cholesterol (TC)

  12 weeks.

• Low-Density Lipoprotein (LDL-C)

  12 weeks.

Study Arms (2)

Fucoxanthin

EXPERIMENTAL

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

Drug: Fucoxanthin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Fucoxanthin DRUG

Intervention will be administered 30 minutes before breakfast.

Fucoxanthin

Placebo DRUG

Intervention will be administered 30 minutes before breakfast.

Also known as: Magnesium Sterate

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

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

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (2)

• 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.

  PMID: 37405785 RESULT

• 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.

  PMID: 33993853 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance

Interventions

fucoxanthin; stearic acid

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: PhD. Karina G. Pérez Rubio
• Organization: University of Guadalajara

karina.prubio@academicos.udg.mx

+52 1 3310585200

Study Officials

• Manuel Gonzalez Ortiz, MD MSc Phd

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 3, 2018
• Study Start: September 30, 2019
• Primary Completion: January 30, 2022
• Study Completion: July 30, 2023
• Last Updated: November 21, 2024
• Results First Posted: November 21, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)