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NCT Number: NCT03613740

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

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

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Guadalajara, Jalisco, 44340, Mexico

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fucoxanthin

Drug

Intervention will be administered 30 minutes before breakfast.

Placebo

Drug

Intervention will be administered 30 minutes before breakfast.

Other names: Magnesium Sterate

Primary outcomes

  1. Waist Circumference (WC)

    Time frame: 12 weeks.

    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.

  2. Fasting Serum Glucose

    Time frame: 12 weeks.

    Fasting serum glucose concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.

  3. Triglycerides (TG)

    Time frame: 12 weeks.

    TG concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.

  4. High-Density Lipoprotein (HDL-C)

    Time frame: 12 weeks.

    Serum HDL-C concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.

  5. Systolic Blood Pressure

    Time frame: 12 weeks.

    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.

  6. Diastolic Blood Pressure

    Time frame: 12 weeks.

    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.

  7. Matsuda-DeFronzo Insulin Sensitivity Index

    Time frame: 12 weeks.

    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.

  8. Total Insulin Secretion

    Time frame: 12 weeks.

    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.

  9. Stumvoll Index

    Time frame: 12 weeks.

    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.

Secondary outcomes

  1. Body Weight

    Time frame: 12 weeks.

    Body weight was measured at baseline a bioimpedance scale.

  2. Body Mass Index (BMI)

    Time frame: 12 weeks.

    BMI was calculated with the Quetelet index formula.

  3. Body Fat

    Time frame: 12 weeks.

    Percentage of body fat was measured using a bioimpedance scale.

  4. Total Cholesterol (TC)

    Time frame: 12 weeks.

    Serum Total Cholesterol concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.

  5. Low-Density Lipoprotein (LDL-C)

    Time frame: 12 weeks.

    Serum LDL-C concentration was calculated using the Friedewald formula (LDL-C = TC - (HDL-C + [TG/5])

  6. Very-Low-Density Lipoprotein (VLDL)

    Time frame: 12 weeks.

    Serum VLDL concentration was calculated with the formula: VLDL-C = TG/5.

  7. Alanine Aminotransferase (ALT)

    Time frame: 12 weeks.

    Serum ALT concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.

  8. Aspartate Aminotransferase (AST)

    Time frame: 12 weeks.

    Serum AST concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.

  9. Creatinin

    Time frame: 12 weeks.

    Serum creatinin concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Aug 3, 2018
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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