Effect of Weight Reduction on Immunity | NCT03336086

Studies
Effect of Weight Reduction on Immunity

NCT03336086

Sponsor

Shiraz University of Medical Sciences

Status

Completed

Last Update Posted

Nov 8, 2017Actual

Enrollment

29Actual

Phase

Phase 3

Conditions

Lymphocytes
Weight Loss
Viral Diseases
Immunity
Anti-obesity Agents

Interventions

weight loss program

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Mar 20, 2012Actual

Primary Completion Date

Nov 30, 2012Actual

Completion Date

Dec 25, 2012Actual

First Submitted Date

Sep 17, 2017

First Submission Date that Met QC Criteria

Nov 7, 2017

First Posted Date

Nov 8, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2017

Last Update Posted Date

Nov 8, 2017Actual

Name	Class
Mashhad University of Medical Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experimental	Other	This group underwent a weight loss program	Combination Product: weight loss program
control	No Intervention	This group underwent adlibitum diet + physical activity

Interventions

Name	Type	Description	Arm Group Labels	Other Names
weight loss program	Combination Product	A low calorie diet+ Orlistat+ Soluble Fiber+ Physical activity	experimental

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Body Mass Index	(Kg/m^2) by equation	6 months
Biomarkers	ZN, Iron (microgram/deciliter) by biochemical assessment	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015431	Weight Loss
D014777	Virus Diseases

Ancestor Terms

ID	Term
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D061217	Weight Reduction Programs

Ancestor Terms

ID	Term
D006293	Health Promotion
D006266	Health Education
D011314	Preventive Health Services
D006296	Health Services

Browse Leaves

Not provided

Browse Branches

Not provided