Effect of whey protein on levels of endocannabinoids, glycemic and lipid profile, inflammatory factors, adipocytokines and body composition in obese women on a weight-loss diet
This is a clinical trial with the goal of determine the effect of whey protein on levels of endocannabinoids, glycemic and lipid profile, inflammatory factors, adipocytokines and body composition in premenopausal obese women on a weight-loss diet. Inclusion criteria include aged 18 years and older; BMI range of 30 to 40 kg/m2; absence of menopause; lactation; pregnancy; food allergies; not having cancer, hepatic, renal, thyroid and gastrointestinal disorders; no surgery for weight loss; no weight loss over the past 6 months; no taking herbs and drug that reduce appetite and weight and vitamin-mineral supplements and exclusion criteria is become pregnant during study; unwilling to continue; no consumption of powders exceed 10% of total administered powders. Eligible subjects will be stratified according to age and BMI randomly assigned to one of two groups: control (standard weight loss group, n=30) and intervention (whey supplementation weight loss group, n=30). Each of intervention group subjects, will receive 30grams whey protein powders per day. Each subject will be interviewed with a questionnaire to collect demographic, physical activity and 24 hr recall information. At baseline and end of trial, 10ml of venous blood samples will be collected after overnight fasting. All participants will follow a hypo-caloric diet of 800 kcal below estimated energy requirements.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021410181N8
Registration date:2017-03-10, 1395/12/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-03-10, 1395/12/20
Registrant information
Name
Fatemeh Heidari
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8255
Email address
haidari-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2017-07-06, 1396/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of whey protein on levels of endocannabinoids, glycemic and lipid profile, inflammatory factors, adipocytokines and body composition in obese women on a weight-loss diet
Public title
Effect of whey protein on weight loss
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria : aged 18 years and older; BMI range of 30 to 40 kg/m2; absence of menopause; lactation; pregnancy; food allergies; not having cancer, hepatic, renal, thyroid and gastrointestinal disorders; no surgery for weight loss; no weight loss over the past 6 months; no taking herbs and drug that reduce appetite and weight and vitamin-mineral supplements. Exclusion criteria: become pregnant during study; unwilling to continue; no consumption of powders exceed 10% of total administered powders.
Age
From 18 years old to 48 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz-Gholestan
City
Ahvaz
Postal code
15794-61357
Approval date
2017-02-07, 1395/11/19
Ethics committee reference number
ir.ajums.REC.1395.729
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Serum Insulin
Timepoint
Before and 2 months after the intervention
Method of measurement
Bloodletting
2
Description
Endocannabinoids
Timepoint
Before and 2 months after the intervention
Method of measurement
Bloodletting
3
Description
Glucose
Timepoint
Before and 2 months after the intervention
Method of measurement
Bloodletting
4
Description
Leptin
Timepoint
Before and 2 months after the intervention
Method of measurement
Bloodletting
5
Description
Interluekin-6
Timepoint
Before and 2 months after the intervention
Method of measurement
Bloodletting
6
Description
Adiponectin
Timepoint
Before and 2 months after the intervention
Method of measurement
Bloodletting
7
Description
TNF-α
Timepoint
Before and 2 months after the intervention
Method of measurement
Bloodletting
8
Description
Lipid profile
Timepoint
Before and 2 months after the intervention
Method of measurement
Bloodletting
9
Description
Weight
Timepoint
Before and 2 months after the intervention
Method of measurement
Seca scale-kg
10
Description
Body Composition
Timepoint
Before and 2 months after the intervention
Method of measurement
Body Composition Analyzer
Secondary outcomes
empty
Intervention groups
1
Description
control group: will receive standard weight loss (macronutrients percent will be carbohydrate55%, fat 30% and 15% protein).
Category
Treatment - Other
2
Description
intervention group: Isocaleric weight loss diet and whey protein powders will be prescribed. Each of intervention group subjects, will receive 30 gram whey protein powders per day.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr.Majid Mohammadshahi,s Diet Therapy Clinic
Full name of responsible person
Vahideh Aghamohammadi
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr.Makhmalzadeh
Street address
Gholestan highway.Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences
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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Vahideh Aghamohammadi
Position
Phd Candidate of Nutrition Sciences
Other areas of specialty/work
Street address
Ahvaz,Gholestan highway,Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
1579461357
Phone
+98 61 3333 9092
Fax
Email
v_agamohammadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Haidari Fatemeh
Position
Nutrition Sciences Phd
Other areas of specialty/work
Street address
Ahvaz.Gholestan highway.Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3333 9092
Fax
Email
haidari58@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Vahideh Aghamohammadi
Position
Phd Candidate of Nutrition Sciences
Other areas of specialty/work
Street address
Ahvaz.Gholestan highway.Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3333 9092
Fax
Email
v_agamohammadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)