Effect of Weight Reduction on Immunity

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

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss; Immunity; Lymphocytes; Viral Diseases; Anti-obesity Agents
• Intervention / Treatment: Combination product: weight loss program

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lymphocyte subgroups	TCD3. TCD4. TCD8. BCD19. NKCs CD16/56 (Cells/microliter) by flowcytometry	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences
• Collaborators: Mashhad University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2012
• Primary Completion (Actual): November 30, 2012
• Study Completion (Actual): December 25, 2012

Study Registration Dates

• First Submitted: September 17, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Actual): November 8, 2017
• Last Update Submitted That Met QC Criteria: November 7, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Overnutrition; Nutrition Disorders; Overweight; Body Weight Changes; Obesity; Virus Diseases; Weight Loss; Body Weight
• Other Study ID Numbers: 900413

Drug and device information, study documents

• 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