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Effects of Flaxseed Supplementation in Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
flaxseed
lifestyle modification
Sponsored by
National Nutrition and Food Technology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age and older
  • having three of the following five features: Increased waist circumference (≥102 cm in men and ≥88 cm in women), elevated TG (≥150 mg/dl), reduced HDL-C (≤40 mg/dl in men and ≤50 mg/dl in women), elevated blood pressure (≥130/85 mm Hg or on treatment for hypertension) and elevated glucose (≥100 mg/dl), according to the National Cholesterol Education Program Adult Treatment Panel III report

Exclusion Criteria:

  • history of allergy or high consumption of nuts, flaxseed, or sesame seeds
  • clinically diagnosed renal, liver, heart, pituitary, thyroid, or psychiatric disorders impairing the patient's ability to provide written informed consent
  • history of cardiovascular diseases, cancers, alimentary tract disorders affecting absorption
  • pregnancy, lactation, and lack of effective birth control in women of child-bearing potential

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Flaxseed

    control

    Arm Description

    30 g milled brown flaxseed + lifestyle modification

    lifestyle modification including dietary and physical activity recommendation

    Outcomes

    Primary Outcome Measures

    Insulin resistance index (HOMA-IR)
    The homeostatic model assessment (HOMA)

    Secondary Outcome Measures

    Full Information

    First Posted
    July 10, 2015
    Last Updated
    July 13, 2015
    Sponsor
    National Nutrition and Food Technology Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02497352
    Brief Title
    Effects of Flaxseed Supplementation in Metabolic Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (undefined)
    Primary Completion Date
    August 2014 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Nutrition and Food Technology Institute

    4. Oversight

    5. Study Description

    Brief Summary
    To evaluate the effects of flaxseed supplementation on fasting blood sugar, lipid profile and anthropocentric measurements in subjects with metabolic syndrome, in a randomized, open-labeled, controlled pilot study, 44 subjects with metabolic syndrome will be received 30g/d flaxseed with lifestyle modification or lifestyle modification alone for 12 weeks. Both groups will be advised to follow an energy balanced diet and physical activity recommendations. Parameters related to metabolic syndrome will be measured at the baseline and at the end of the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Flaxseed
    Arm Type
    Experimental
    Arm Description
    30 g milled brown flaxseed + lifestyle modification
    Arm Title
    control
    Arm Type
    Active Comparator
    Arm Description
    lifestyle modification including dietary and physical activity recommendation
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    flaxseed
    Intervention Type
    Behavioral
    Intervention Name(s)
    lifestyle modification
    Primary Outcome Measure Information:
    Title
    Insulin resistance index (HOMA-IR)
    Description
    The homeostatic model assessment (HOMA)
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years of age and older having three of the following five features: Increased waist circumference (≥102 cm in men and ≥88 cm in women), elevated TG (≥150 mg/dl), reduced HDL-C (≤40 mg/dl in men and ≤50 mg/dl in women), elevated blood pressure (≥130/85 mm Hg or on treatment for hypertension) and elevated glucose (≥100 mg/dl), according to the National Cholesterol Education Program Adult Treatment Panel III report Exclusion Criteria: history of allergy or high consumption of nuts, flaxseed, or sesame seeds clinically diagnosed renal, liver, heart, pituitary, thyroid, or psychiatric disorders impairing the patient's ability to provide written informed consent history of cardiovascular diseases, cancers, alimentary tract disorders affecting absorption pregnancy, lactation, and lack of effective birth control in women of child-bearing potential

    12. IPD Sharing Statement

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