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Comparison of changes in lymphocyte subpopulations during weight loss program on obese subjects and control group

Protocol summary

Summary
Objective: To study the effect of weight loss program on plasma count of important lymphocyte subtypes (CD3, CD4, CD8, CD19, CD16/56) in non-pregnant, non-lactating, obese premenopausal females and comparison to the control group. Methods: In a randomized controlled trial, 29 females were enrolled. The intervention group was selected by chance, and the control group was matched by BMI and age with cases. All the intervention and control subjects must be analyzed for their healthy status. Blood sampling for primary outcome measures was done in one of these days of cycle (7th, 8th, 9th, 10th of monthly cycle). Body composition, serum zinc and iron status and plasma count of lymphocyte subpopulations were measured, at baseline and at the end of the intervention. Intervention group received a low calorie diet (3976.7 kJ/ 950 kcal per day) plus Lipase inhibitor (Orlistat), soluble fiber, and daily moderate physical activity (VO2max 60%), until 10-15% weight loss. Data were analyzed and compared between intervention and control groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014052617872N1
Registration date: 2014-10-30, 1393/08/08
Registration timing: na

Last update:
Update count: 0
Registration date
2014-10-30, 1393/08/08
Registrant information
Name
Mahsa Mehrdad
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1005
Email address
mehrdad@sums.ac.ir
Recruitment status
Not enough for processing
Funding source
Vice Chancellor for Research of Mashhad University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of changes in lymphocyte subpopulations during weight loss program on obese subjects and control group
Public title
assessment of immune system during Low Calorie Diet induced weight loss
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Female; Age 25-40years; BMI ≥ 30.00; Normal thyroid function; Normal blood cortisol; Normal mensturation; Healthy individuals(without any certain diseases); Normal HbA1c; Normal blood glucose test; Non smokers; non alcohol consumption Exclusion criteria:Any drug consumption; Anemic Individuals
Age
From 25 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 29
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Scienses
Street address
Medicine Faculty, Mashhad University of Medical Scienses, Vakil Abad Avenue, Mashhad, Khorasan Razavi
City
Mashhad
Postal code
Approval date
2012-05-23, 1391/03/03
Ethics committee reference number
900413

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66.9
ICD-10 code description
Simple obesity NOS

Primary outcomes

1

Description
T Lymphocyte CD4+
Timepoint
Befor and after the intervention (Day 0 of intervention and after 10-15% weight loss)
Method of measurement
flow cytometry

2

Description
T Lymphocyte CD3+
Timepoint
Befor and after the intervention (Day 0 of intervention and after 10-15% weight loss)
Method of measurement
flow cytometry

3

Description
B Lymphocyte CD19+
Timepoint
Befor and after the intervention (Day 0 of intervention and after 10-15% weight loss)
Method of measurement
flow cytometry

4

Description
Natural Killer Cells CD16/56+
Timepoint
Befor and after the intervention (Day 0 of intervention and after 10-15% weight loss)
Method of measurement
flow cytometry

5

Description
T Lymphocyte CD8+
Timepoint
Befor and after the intervention (Day 0 of intervention and after 10-15% weight loss)
Method of measurement
flow cytometry

Secondary outcomes

1

Description
Zinc
Timepoint
Befor and after the intervention (Day 0 of intervention and after 10-15% weight loss)
Method of measurement
Blood test

2

Description
Iron
Timepoint
Befor and after the intervention (Day 0 of intervention and after 10-15% weight loss)
Method of measurement
Blood test

Intervention groups

1

Description
Low Calorie Diet by 500 Kcal less than reqirement up to 10-15% weight loss
Category
Treatment - Other

2

Description
administration of orlistat(120mg) twice a day with lunch and dinner
Category
Treatment - Drugs

3

Description
1 hour moderate physical activity(VO2 max 60%)
Category
Lifestyle

4

Description
Administration of 15gr soluble fiber twice a day before lunch and dinner
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Qaem nutrition and diet thrapy Clinic
Full name of responsible person
Dr.Abdolreza Norouzy
Street address
Qaem Clinic, Qaem Hospital, Ahmad Abad St, Mashhad, Khorasane Razavi
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Scienses
Full name of responsible person
Dr. Abdolreza Norouzy
Street address
Medicine Faculty, Mashhad University of Medical Sciences, Vakil Abd St, Mashhad, Khorasane Razavi
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Scienses
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Scienses
Full name of responsible person
Mahsa Mehrdad
Position
student
Other areas of specialty/work
Street address
Medicine Faculty, Mashhad University of Medical Scienses, Mashhad, Khorasane razavi
City
Mashhad
Postal code
Phone
+98 918 380 9662
Fax
Email
Mehrdad@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abdolreza Norouzy
Position
Ph.D of Nutrition
Other areas of specialty/work
Street address
Medicine Faculty, Mashhad University of Medical Scienses, Mashhad, Khorasane razavi
City
Mashhad
Postal code
Phone
+98 51 1800 2382
Fax
Email
NorouzyA@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Scienses
Full name of responsible person
Mahsa Mehrdad
Position
Ph.D student
Other areas of specialty/work
Street address
khorasane razavi-mashhad-mashhad university of medical sciences
City
Mashhad
Postal code
Phone
+98 918 380 9662
Fax
Email
Mehrdad@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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