Effect of Weight Reduction on Immunity

Weight Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03336086
• Other study ID #: 900413
• Status: Completed
• Phase: Phase 3
• First received: September 17, 2017
• Last updated: November 7, 2017
• Start date: March 20, 2012
• Est. completion date: December 25, 2012

Study information

• Verified date: October 2017
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 25, 2012
• Est. primary completion date: November 30, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anti-obesity Agents
• Body Weight
• Immunity
• Lymphocytes
• Obesity
• Viral Diseases
• Virus Diseases
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences	Mashhad University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lymphocyte subgroups	TCD3. TCD4. TCD8. BCD19. NKCs CD16/56 (Cells/microliter) by flowcytometry	6 months
Secondary	Body Mass Index	(Kg/m^2) by equation	6 months
Secondary	Biomarkers	ZN, Iron (microgram/deciliter) by biochemical assessment	6 months
Secondary	Systolic blood pressure	(mmHg) by manometer	6 months
Secondary	diastolic blood pressure	(mmHg) by manometer	6 months
Secondary	Weight	(Kg) by Bioelectric impedance analyser	6 months
Secondary	Fat Mass	(Kg) by Bioelectric impedance analyser	6 months
Secondary	Fat Free Mass	(Kg) by Bioelectric impedance analyser	6 months
Secondary	Trunk Fat	(Kg) by Bioelectric impedance analyser	6 months
Secondary	Waist circumference	(cm) by meter tape	6 months