Effect of Weight Reduction on Immunity

Phase 3

Completed

• Conditions: Lymphocytes; Viral Diseases; Immunity; Anti-obesity Agents; Weight Loss
• Interventions: Combination Product: weight loss program

• Registration Number: NCT03336086
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study Start: 2012-03-20
• Primary Completion: 2012-11-30
• Study Completion: 2012-12-25
• Study First Submitted: 2017-09-17
• Status Verified: 2017-10
• Study First Submitted QC: 2017-11-07
• Last Update Submitted: 2017-11-07
• Study First Posted: 2017-11-08
• Last Update Posted: 2017-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental	weight loss program	This group underwent a weight loss program

Primary Outcome Measures

Name	Time	Method
lymphocyte subgroups	6 months	TCD3. TCD4. TCD8. BCD19. NKCs CD16/56 (Cells/microliter) by flowcytometry

Secondary Outcome Measures

Name	Time	Method
Systolic blood pressure	6 months	(mmHg) by manometer
diastolic blood pressure	6 months	(mmHg) by manometer
Fat Free Mass	6 months	(Kg) by Bioelectric impedance analyser
Waist circumference	6 months	(cm) by meter tape
Weight	6 months	(Kg) by Bioelectric impedance analyser
Fat Mass	6 months	(Kg) by Bioelectric impedance analyser
Body Mass Index	6 months	(Kg/m\^2) by equation
Trunk Fat	6 months	(Kg) by Bioelectric impedance analyser
Biomarkers	6 months	ZN, Iron (microgram/deciliter) by biochemical assessment