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The Effects of Flaxseed Supplement on Weight and Biochemical Factors in Overweight and Obese Subject

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
flaxseed
Placebo
Exercise recommendation
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 Overweight and Obesity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age of 18 to 70 years
  • Body Mass Index (BMI) between 25-40

Exclusion Criteria:

  • diabetes mellitus
  • cardiovascular diseases and cancers
  • major systemic diseases
  • gastrointestinal problems
  • liver and renal failure
  • history of allergy or high consumption of nuts, flaxseed, or sesame seeds
  • weight loss within the past 6 mo of >5% of body weight or current adherence to a weight-reduction diet
  • pregnancy, lactation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Flaxseed

    control

    Arm Description

    30 grams Flaxseed powder combine with dietary and exercise recommendation

    dietary and exercise recommendation

    Outcomes

    Primary Outcome Measures

    weight
    waist and hip circumference

    Secondary Outcome Measures

    lipid profile

    Full Information

    First Posted
    April 2, 2015
    Last Updated
    April 6, 2015
    Sponsor
    National Nutrition and Food Technology Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02410668
    Brief Title
    The Effects of Flaxseed Supplement on Weight and Biochemical Factors in Overweight and Obese Subject
    Official Title
    The Effects of Flaxseed Supplement on Weight, Lipid Profile and Inflammatory Factors in Overweight and Obese Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2014 (undefined)
    Primary Completion Date
    August 2014 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To study the effects of Flaxseed supplement on weight, lipid profile and inflammatory factors in subjects with over weight and obesity, 50 patients will be randomly allocated to receive placebo or 30 grams milled Flaxseed for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, weight, waist and hip circumference, lipid profile and some inflammatory markers will be assessed and compared between groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight and Obesity

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Flaxseed
    Arm Type
    Active Comparator
    Arm Description
    30 grams Flaxseed powder combine with dietary and exercise recommendation
    Arm Title
    control
    Arm Type
    Placebo Comparator
    Arm Description
    dietary and exercise recommendation
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    flaxseed
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise recommendation
    Primary Outcome Measure Information:
    Title
    weight
    Time Frame
    12 weeks
    Title
    waist and hip circumference
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    lipid profile
    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
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age of 18 to 70 years Body Mass Index (BMI) between 25-40 Exclusion Criteria: diabetes mellitus cardiovascular diseases and cancers major systemic diseases gastrointestinal problems liver and renal failure history of allergy or high consumption of nuts, flaxseed, or sesame seeds weight loss within the past 6 mo of >5% of body weight or current adherence to a weight-reduction diet pregnancy, lactation

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30843767
    Citation
    Yari Z, Rahimlou M, Poustchi H, Hekmatdoost A. Flaxseed supplementation improves anthropometric measurements, metabolic, and inflammatory biomarkers in overweight and obese adults. Int J Vitam Nutr Res. 2022 Jul;92(3-4):161-168. doi: 10.1024/0300-9831/a000565. Epub 2019 Mar 7.
    Results Reference
    derived

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    The Effects of Flaxseed Supplement on Weight and Biochemical Factors in Overweight and Obese Subject

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