Phase 2
N=28
Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Metabolic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03613740 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Waist Circumference (WC) — 98.9; 102.1 cm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fucoxanthin (Drug); Placebo (Drug)
- Age
- Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Guadalajara
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Waist Circumference (WC) |
98.9; 102.1 | — |
| PRIMARY Fasting Serum Glucose |
5.5; 5.6 | — |
| PRIMARY Triglycerides (TG) |
2.1; 2.4 | — |
| PRIMARY High-Density Lipoprotein (HDL-C) |
1.2; 1.2 | — |
| PRIMARY Systolic Blood Pressure |
120.8; 119.1 | — |
| PRIMARY Diastolic Blood Pressure |
78.6; 79.2 | — |
| PRIMARY Matsuda-DeFronzo Insulin Sensitivity Index |
2.19; 2.19 | — |
| PRIMARY Total Insulin Secretion |
1.02; 0.85 | — |
| PRIMARY Stumvoll Index |
2907; 2298 | — |
| SECONDARY Body Weight |
79.16; 82.1 | — |
| SECONDARY Body Mass Index (BMI) |
30.3; 31.0 | — |
| SECONDARY Body Fat |
33.0; 34.9 | — |
| SECONDARY Total Cholesterol (TC) |
5.1; 4.9 | — |
| SECONDARY Low-Density Lipoprotein (LDL-C) |
3.0; 2.7 | — |
| SECONDARY Very-Low-Density Lipoprotein (VLDL) |
0.9; 1.1 | — |
| SECONDARY Alanine Aminotransferase (ALT) |
0.47; 0.50 | — |
| SECONDARY Aspartate Aminotransferase (AST) |
0.41; 0.42 | — |
| SECONDARY Creatinin |
83.8; 76.4 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT03613740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.