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Trial record 57 of 69 for:    ORLISTAT

Effect of Weight Reduction on Immunity

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ClinicalTrials.gov Identifier: NCT03336086
Recruitment Status : Completed
First Posted : November 8, 2017
Last Update Posted : November 8, 2017
Sponsor:
Collaborator:
Mashhad University of Medical Sciences
Information provided by (Responsible Party):
Mahsa Mehrdad, Shiraz University of Medical Sciences

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
Lymphocytes Weight Loss Viral Diseases Immunity Anti-obesity Agents 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

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Study Type : Interventional  (Clinical Trial)
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 : March 20, 2012
Actual Primary Completion Date : November 30, 2012
Actual Study Completion Date : December 25, 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
experimental
This group underwent a weight loss program
Combination Product: weight loss program
A low calorie diet+ Orlistat+ Soluble Fiber+ Physical activity
Other Name: experimental

No Intervention: control
This group underwent adlibitum diet + physical activity



Primary Outcome Measures :
  1. lymphocyte subgroups [ Time Frame: 6 months ]
    TCD3. TCD4. TCD8. BCD19. NKCs CD16/56 (Cells/microliter) by flowcytometry


Secondary Outcome Measures :
  1. Body Mass Index [ Time Frame: 6 months ]
    (Kg/m^2) by equation

  2. Biomarkers [ Time Frame: 6 months ]
    ZN, Iron (microgram/deciliter) by biochemical assessment

  3. Systolic blood pressure [ Time Frame: 6 months ]
    (mmHg) by manometer

  4. diastolic blood pressure [ Time Frame: 6 months ]
    (mmHg) by manometer

  5. Weight [ Time Frame: 6 months ]
    (Kg) by Bioelectric impedance analyser

  6. Fat Mass [ Time Frame: 6 months ]
    (Kg) by Bioelectric impedance analyser

  7. Fat Free Mass [ Time Frame: 6 months ]
    (Kg) by Bioelectric impedance analyser

  8. Trunk Fat [ Time Frame: 6 months ]
    (Kg) by Bioelectric impedance analyser

  9. Waist circumference [ Time Frame: 6 months ]
    (cm) by meter tape



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

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Responsible Party: Mahsa Mehrdad, Principal investigator, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03336086     History of Changes
Other Study ID Numbers: 900413
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Obesity
Body Weight
Weight Loss
Virus Diseases
Overnutrition
Nutrition Disorders
Overweight
Signs and Symptoms
Body Weight Changes