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Effect of Weight Reduction on Immunity

Sponsor
Shiraz University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT03336086
Collaborator
Mashhad University of Medical Sciences (Other)
29
Enrollment
2
Arms
9.2
Actual Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: weight loss program
 Phase 3

Detailed Description

TCD3 and NKC CD16/56 were decreased significantly. Hence this weight loss program impaired viral immunity

Study Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
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
Actual Study Start Date :
Mar 20, 2012
Actual Primary Completion Date :
Nov 30, 2012
Actual Study Completion Date :
Dec 25, 2012

Arms and Interventions

Arm Intervention/Treatment
Other: experimental

This group underwent a weight loss program

Combination Product: weight loss program
A low calorie diet+ Orlistat+ Soluble Fiber+ Physical activity
Other Names:
  • experimental

    		•
    No Intervention: control

    This group underwent adlibitum diet + physical activity

    Outcome Measures

    Primary Outcome Measures

    1. lymphocyte subgroups [6 months]

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

    Secondary Outcome Measures

    1. Body Mass Index [6 months]

      (Kg/m^2) by equation

    2. Biomarkers [6 months]

      ZN, Iron (microgram/deciliter) by biochemical assessment

    3. Systolic blood pressure [6 months]

      (mmHg) by manometer

    4. diastolic blood pressure [6 months]

      (mmHg) by manometer

    5. Weight [6 months]

      (Kg) by Bioelectric impedance analyser

    6. Fat Mass [6 months]

      (Kg) by Bioelectric impedance analyser

    7. Fat Free Mass [6 months]

      (Kg) by Bioelectric impedance analyser

    8. Trunk Fat [6 months]

      (Kg) by Bioelectric impedance analyser

    9. Waist circumference [6 months]

      (cm) by meter tape

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Shiraz University of Medical Sciences
    • Mashhad University of Medical Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mahsa Mehrdad, Principal investigator, Shiraz University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT03336086
    Other Study ID Numbers:
    • 900413
    First Posted:
    Nov 8, 2017
    Last Update Posted:
    Nov 8, 2017
    Last Verified:
    Oct 1, 2017
    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
    Additional relevant MeSH terms:
    Virus Diseases
    Obesity
    Body Weight
    Weight Loss

    Study Results

    No Results Posted as of Nov 8, 2017