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Trial record 19 of 93 for:    high | Recruiting, Not yet recruiting, Available Studies | "Metabolic Syndrome X"

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

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ClinicalTrials.gov Identifier: NCT03613740
Recruitment Status : Not yet recruiting
First Posted : August 3, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Manuel González Ortiz, University of Guadalajara

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


Condition or disease Intervention/treatment Phase
Metabolic Syndrome Drug: Fucoxanthin Drug: Placebo Phase 2

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Fucoxanthin on the Components of the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fucoxanthin
12 mg Fucoxanthin capsule, once a day before breakfast during 90 days.
Drug: Fucoxanthin
Intervention will be administered 30 minutes before breakfast.

Placebo Comparator: Placebo
Homologated magnesium sterate capsule, once a day before breakfast during 90 days.
Drug: Placebo
Intervention will be administered 30 minutes before breakfast.
Other Name: Magnesium Sterate




Primary Outcome Measures :
  1. Changes in Baseline Waist Circumference after intervention. [ Time Frame: Baseline, Day 30, Day 60 and Day 90. ]
    Waist circumference will be measured at baseline, day 30, day 60 and day 90 with a validated metric tape, with the method proposed by ISAK. Values will be expressed in centimeters (cm).

  2. Changes in Baseline Fasting Serum Glucose level after Intervention. [ Time Frame: Baseline and Day 90. ]
    Fasting serum glucose level will be measured at baseline and day 90 with enzymatic/colorimetric techniques. Values will be expressed in milligrams per deciliter (mg/dL).

  3. Changes in Baseline Triglycerides (TG) level after Intervention. [ Time Frame: Baseline and Day 90. ]
    Serum triglycerides level will be measured at baseline and day 90 with enzymatic/colorimetric techniques. Values will be expressed in milligrams per deciliter (mg/dL).

  4. Changes in Baseline High-density Lipoprotein (HDL-C) level after Intervention. [ Time Frame: Baseline and Day 90. ]
    Serum HDL-C level will be measured at baseline and day 90 with enzymatic/colorimetric techniques. Values will be expressed in milligrams per deciliter (mg/dL).

  5. Changes in Baseline Systolic Blood Pressure level after Intervention. [ Time Frame: Baseline, Day 30, Day 60 and Day 90. ]
    Systolic blood pressure will be measured at baseline, day 30, day 60 and day 90 with a digital sphygmomanometer. Values will be expressed in millimeters of mercury (mmHg).

  6. Changes in Baseline Diastolic Blood Pressure level after Intervention. [ Time Frame: Baseline, Day 30, Day 60 and Day 90. ]
    Diastolic blood pressure will be measured at baseline, day 30, day 60 and day 90 with a digital sphygmomanometer. Values will be expressed in millimeters of mercury (mmHg).

  7. Changes in Baseline Insulin Sensitivity (Matsuda-DeFronzo insulin sensitivity index) after Intervention. [ Time Frame: Baseline and Day 90. ]
    Insulin sensitivity will be determined at baseline and day 90 with the Matsuda-DeFronzo insulin sensitivity index. Calculated from serum concentrations of insulin (by ELISA) and glucose, obtained during an oral glucose tolerance test (OGTT). A value of <4.3 predict impaired insulin sensitivity. Uses the following formula: Matsuda index = 10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT).

  8. Changes in Baseline Total Insulin Secretion (Insulinogenic index) after Intervention. [ Time Frame: Baseline and Day 90. ]
    Total insulin secretion will be determined at baseline and day 90 with Insulinogenic index. Insulinogenic index helps to estimate the total insulin secretion. Calculated from serum concentrations of insulin (by ELISA) and glucose, obtained during an oral glucose tolerance test (OGTT). Using the following formula: Insulinogenic Index = δAUCinsulin/δAUCglucose.

  9. Changes in Baseline First Phase of Insulin Secretion (Stumvoll index) after Intervention. [ Time Frame: Baseline and Day 90. ]
    First phase of insulin secretion will be calculated at baseline and day 90 with Stumvoll index. Stumvoll index estimate the first phase of insulin secretion using demographic data in addition to plasma glucose (mmol/L) and insulin (pmol/L) levels obtained during an oral glucose tolerance test (OGTT). Calculated with the following formula: Stumvoll index = 1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'.


Secondary Outcome Measures :
  1. Changes in Baseline Body Weight after Intervention. [ Time Frame: Baseline, Day 30, Day 60 and Day 90. ]
    Body weight will be measured at baseline, day 30, day 60 and day 90 with a bioimpedance scale. Values will be expressed in kilograms (kg).

  2. Changes in Baseline Body Mass Index (BMI) after Intervention. [ Time Frame: Baseline, Day 30, Day 60 and Day 90. ]
    Body Mass Index will be calculated at baseline, day 30, day 60 and day 90 with with the Quetelet index formula, using a bioimpedance scale. Values will be expressed in kilograms per square meter (km/m2).

  3. Changes in Baseline Percentage of Body Fat after intervention. [ Time Frame: Baseline, Day 30, Day 60 and Day 90. ]
    Percentage of body fat will be measured at baseline, day 30, day 60 and day 90 with a bioimpedance scale. Values will be expressed in percentages.

  4. Changes in Baseline Total Cholesterol (TC) level after intervention. [ Time Frame: Baseline and Day 90. ]
    Serum total cholesterol level will be measured at baseline and day 90 with enzymatic/colorimetric techniques. Values will be expressed in milligrams per deciliter (mg/dL).

  5. Changes in Baseline Low-density lipoprotein (LDL-C) levels after intervention. [ Time Frame: Baseline and Day 90. ]
    Serum LDL-C level will be calculated at baseline and day 90 with the Friedewald formula: LDL-C = TC - (HDL-C + [TG/5]). Values will be expressed in milligrams per deciliter (mg/dL).

  6. Changes in Baseline Very-low-density Lipoprotein (VLDL-C) level after intervention. [ Time Frame: Baseline and Day 90. ]
    Serum VLDL-C level will be calculated at baseline and day 90 with the formula: VLDL-C = TG/5. Values will be expressed in milligrams per deciliter (mg/dL).

  7. Changes in Baseline Alanine Aminotransferase (ALT) level after intervention. [ Time Frame: Baseline and Day 90. ]
    Serum alanine aminotransferase level will be measured at baseline and day 90 with enzymatic/colorimetric techniques. Values will be expressed in milligrams per deciliter (mg/dL).

  8. Changes in Baseline Aspartate Aminotransferase (AST) level after intervention. [ Time Frame: Baseline and Day 90. ]
    Serum aspartate aminotransferase level will be measured at baseline and day 90 with enzymatic/colorimetric techniques. Values will be expressed in milligrams per deciliter (mg/dL).

  9. Changes in Baseline Creatinin level after intervention. [ Time Frame: Baseline and Day 90. ]
    Serum creatinin level will be measured at baseline and day 90 with enzymatic/colorimetric techniques. Values will be expressed in milligrams per deciliter (mg/dL).


Other Outcome Measures:
  1. Presence of treatment-related adverse events during the intervention. [ Time Frame: Day 30, Day 60 and Day 90. ]
    Number of participants presenting treatment-related adverse events will be determined with oral questionnaires to the participants and with the records in a treatment-adherence diary (provided to the participant) at day 30, day 60 and day 90, as assessed by the common terminology criteria for adverse events (CTCAE) v5.0



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03613740


Contacts
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Contact: Manuel Gonzalez Ortiz, MD MSc Phd +523310585200 ext 34212 uiec@prodigy.net.mx
Contact: Karina G Perez Rubio, PhD +523310585200 ext 34212 karina2410@hotmail.com

Locations
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Mexico
Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, Mexico, 44340
Sponsors and Collaborators
University of Guadalajara
Investigators
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Principal Investigator: Manuel Gonzalez Ortiz, MD MSc Phd University of Guadalajara

Publications:

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Responsible Party: Manuel González Ortiz, Researcher Professor, University of Guadalajara
ClinicalTrials.gov Identifier: NCT03613740     History of Changes
Other Study ID Numbers: Fucoxanthin-MS
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Manuel González Ortiz, University of Guadalajara:
Insulin Sensitivity
Metabolic Syndrome
Fucoxanthin
Insulin Secretion

Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Hypersensitivity
Insulin Resistance
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs