Trial intelligence / Profile preview

Effect of Fucoxanthin on Metabolic Syndrome

NCT03613740Phase 2

Key facts

Status: Completed
Start: Sep 2019
Primary completion: Jan 2022
Countries: 1
Sponsor: Universidad de Guadalajara
Modality: Covalent Small Molecules, Classical Binding Small Molecules, Nucleic Acid-Directed Small Molecules

Drugs: fucoxanthin
Conditions: metabolic syndrome

Overview

Phase 2, randomised, double-blind trial in metabolic syndrome comparing Fucoxanthin with Placebo (2 arms). Primary endpoints: Waist Circumference at 12 weeks, Fasting Serum Glucose at 12 weeks and 7 more. Started Sep 2019; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Fucoxanthin
12 mg Fucoxanthin capsule, once a day before breakfast.
Placebo
Homologated magnesium stearate capsule, once a day before breakfast.

Who it enrols

Adults aged 30-60 with diagnosed Metabolic Syndrome according to IDF criteria, BMI 25-34.9, and no pharmacological treatment for MS. Excludes pregnancy, kidney or liver disease, and diabetes (Glucose >= 126 or HbA1c >= 6.5%).

Endpoints

Primary

Waist Circumference12 weeks
Fasting Serum Glucose12 weeks
Triglycerides12 weeks
High-Density Lipoprotein Cholesterol12 weeks
Systolic Blood Pressure12 weeks

Secondary

Body Weight12 weeks
Body Mass Index12 weeks
Body Fat12 weeks
Total Cholesterol12 weeks
Low-Density Lipoprotein Cholesterol12 weeks
Very-Low-Density Lipoprotein Cholesterol12 weeks
Alanine Aminotransferase12 weeks
Aspartate Aminotransferase12 weeks

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