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

• Status: Recruiting
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Guadalajara
• Treatments: Insulin; Insulin, Globin Zinc

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