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OpenTrials
Completed

NCT Number: NCT03336086

Effect of Weight Reduction on Immunity

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.

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Key information

Conditions

Lymphocytes Anti-obesity Agents Body Weight Body Weight Changes Immunity Infections Pathological Conditions, Signs and Symptoms Signs and Symptoms Viral Diseases Virus Diseases Weight Loss

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

weight loss program

Combination Product

A low calorie diet+ Orlistat+ Soluble Fiber+ Physical activity

Other names: experimental

Primary outcomes

  1. lymphocyte subgroups

    Time frame: 6 months

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Collaborators

  • Mashhad University of Medical Sciences

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 8, 2017
Registry last updated
Nov 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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