Clinical trial NCT03613740: Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Official title: Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metabolic Syndrome
Keywords: Insulin Sensitivity
Metabolic Syndrome
Fucoxanthin
Insulin Secretion
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 28
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Waist Circumference (WC)
timeFrame: 12 weeks.
measure: Fasting Serum Glucose
timeFrame: 12 weeks.
measure: Triglycerides (TG)
timeFrame: 12 weeks.
measure: High-Density Lipoprotein (HDL-C)
timeFrame: 12 weeks.
measure: Systolic Blood Pressure
timeFrame: 12 weeks.
measure: Diastolic Blood Pressure
timeFrame: 12 weeks.
measure: Matsuda-DeFronzo Insulin Sensitivity Index
timeFrame: 12 weeks.
measure: Total Insulin Secretion
timeFrame: 12 weeks.
measure: Stumvoll Index
timeFrame: 12 weeks.
Secondary outcomes:
measure: Body Weight
timeFrame: 12 weeks.
measure: Body Mass Index (BMI)
timeFrame: 12 weeks.
measure: Body Fat
timeFrame: 12 weeks.
measure: Total Cholesterol (TC)
timeFrame: 12 weeks.
measure: Low-Density Lipoprotein (LDL-C)
timeFrame: 12 weeks.
measure: Very-Low-Density Lipoprotein (VLDL)
timeFrame: 12 weeks.
measure: Alanine Aminotransferase (ALT)
timeFrame: 12 weeks.
measure: Aspartate Aminotransferase (AST)
timeFrame: 12 weeks.
measure: Creatinin
timeFrame: 12 weeks.
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: Manuel Gonzalez Ortiz, MD MSc Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.