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Effect of Weight Reduction on Immunity

Primary Purpose

Lymphocytes, Weight Loss, Viral Diseases

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
weight loss program
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lymphocytes

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI >=30
  • female
  • healthy
  • no smoking
  • not lactating
  • not pregnant
  • no medication use

Exclusion Criteria:

  • pregnancy
  • any disease
  • any medication use
  • iron and zinc deficiency
  • any supplement use

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    No Intervention

    Arm Label

    experimental

    control

    Arm Description

    This group underwent a weight loss program

    This group underwent adlibitum diet + physical activity

    Outcomes

    Primary Outcome Measures

    lymphocyte subgroups
    TCD3. TCD4. TCD8. BCD19. NKCs CD16/56 (Cells/microliter) by flowcytometry

    Secondary Outcome Measures

    Body Mass Index
    (Kg/m^2) by equation
    Biomarkers
    ZN, Iron (microgram/deciliter) by biochemical assessment
    Systolic blood pressure
    (mmHg) by manometer
    diastolic blood pressure
    (mmHg) by manometer
    Weight
    (Kg) by Bioelectric impedance analyser
    Fat Mass
    (Kg) by Bioelectric impedance analyser
    Fat Free Mass
    (Kg) by Bioelectric impedance analyser
    Trunk Fat
    (Kg) by Bioelectric impedance analyser
    Waist circumference
    (cm) by meter tape

    Full Information

    First Posted
    September 17, 2017
    Last Updated
    November 7, 2017
    Sponsor
    Shiraz University of Medical Sciences
    Collaborators
    Mashhad University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03336086
    Brief Title
    Effect of Weight Reduction on Immunity
    Official Title
    Reduction of Natural Killer Cell (CD16/56) and T-lymphocyte (CD3) Subset Counts After a Weight Loss Program Using Anti-obesity Drugs in Obese Women: a Non-randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 20, 2012 (Actual)
    Primary Completion Date
    November 30, 2012 (Actual)
    Study Completion Date
    December 25, 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shiraz University of Medical Sciences
    Collaborators
    Mashhad University of Medical Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    This study included two groups of premenopausal healthy obese women. Experimental group underwent a weight loss program involved a low calorie diet plus anti-obesity drugs and moderate physical activity and control group underwent an ad libitum diet. At baseline and after a 10-15% weight loss lymphocyte subgroups were analyzed and compared between two group.
    Detailed Description
    TCD3 and NKC CD16/56 were decreased significantly. Hence this weight loss program impaired viral immunity

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphocytes, Weight Loss, Viral Diseases, Immunity, Anti-obesity Agents

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    29 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    experimental
    Arm Type
    Other
    Arm Description
    This group underwent a weight loss program
    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    This group underwent adlibitum diet + physical activity
    Intervention Type
    Combination Product
    Intervention Name(s)
    weight loss program
    Other Intervention Name(s)
    experimental
    Intervention Description
    A low calorie diet+ Orlistat+ Soluble Fiber+ Physical activity
    Primary Outcome Measure Information:
    Title
    lymphocyte subgroups
    Description
    TCD3. TCD4. TCD8. BCD19. NKCs CD16/56 (Cells/microliter) by flowcytometry
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Body Mass Index
    Description
    (Kg/m^2) by equation
    Time Frame
    6 months
    Title
    Biomarkers
    Description
    ZN, Iron (microgram/deciliter) by biochemical assessment
    Time Frame
    6 months
    Title
    Systolic blood pressure
    Description
    (mmHg) by manometer
    Time Frame
    6 months
    Title
    diastolic blood pressure
    Description
    (mmHg) by manometer
    Time Frame
    6 months
    Title
    Weight
    Description
    (Kg) by Bioelectric impedance analyser
    Time Frame
    6 months
    Title
    Fat Mass
    Description
    (Kg) by Bioelectric impedance analyser
    Time Frame
    6 months
    Title
    Fat Free Mass
    Description
    (Kg) by Bioelectric impedance analyser
    Time Frame
    6 months
    Title
    Trunk Fat
    Description
    (Kg) by Bioelectric impedance analyser
    Time Frame
    6 months
    Title
    Waist circumference
    Description
    (cm) by meter tape
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: BMI >=30 female healthy no smoking not lactating not pregnant no medication use Exclusion Criteria: pregnancy any disease any medication use iron and zinc deficiency any supplement use

    12. IPD Sharing Statement

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    Effect of Weight Reduction on Immunity

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