1. Home
  2. Approved trials
  3. » فارسی

Effects of whey protein isolate long term consumption in comparison with soy protein isolate on appetite and calorie intake، anthropometric and metabolic indices, inflammatory and oxidative stress factors in healthy overweight and obese men

Protocol summary

Summary
(1)Objectives: Effects of whey protein isolate long term consumption in comparison with soy protein isolate on appetite and calorie intake، anthropometric and metabolic indices, inflammatory and oxidative stress factors in healthy overweight and obese men. (2) Design: Randomized, double blind, control without placebo, clinical trial phase 3 (3) Setting and Conduct: After the completing the written consent, the participants are randomized in to either the WPI (to intake 60 grams whey protein isolate) or SPI (to intake 60 grams soy protein isolate).In this study participants of each group intake the supplements solved in 500 ml water 30 minutes before lunch .Before and after the study demographic questionnaire, IPAC and 24 recall are filled out. Appetite, Calorie intake, blood pressure, anthropometric measurement, body composition and plasma Glucose ,TC, VLDL,TG, LDL, HDL, Apolipoproteins a and b, HsCRP, MDA are measured. (4) Participants: 52 healthy overweight and obese men 30 to 65 years old. Inclusion Criteria: Healthy interested men between ages 30 to 65; BMI=25-40kg/m2; No usage of cigarette or drugs or alcohol; No usage of antioxidants; No usage of decreasing blood pressure drugs, decreasing blood lipids or decreasing blood glucose drugs; No usage of antioxidants, gain or lose weight supplements; No lose weight diets; No intake of high doses of caffeine during the last 3 months; No records of diabetes, high blood pressure, acute heart diseases or thyroid/kidney/liver diseases, blood disorders, infarction or other clinical problems increasing oxidative stress like injuries or sever burnings; No allergy to cow milk or soy; No sever weight change during the last month; No usage of drugs affecting body weight ( Hormones or antidepression drugs) Exclusion Criteria; Altering the activity levels or diets in comparison with the ones before the study; Compliance less than 70% (5) Interventions: Intake of 60 grams of whey protein isolate or soy protein isolate (6)Main outcome measures: appetite, body weight, body composition

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201109062365N3
Registration date: 2012-02-21, 1390/12/02
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-02-21, 1390/12/02
Registrant information
Name
Mohammad Reza Vafa
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4734
Email address
vafa.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2012-06-04, 1391/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of whey protein isolate long term consumption in comparison with soy protein isolate on appetite and calorie intake، anthropometric and metabolic indices, inflammatory and oxidative stress factors in healthy overweight and obese men
Public title
Effects of whey protein isolate long term consumption in comparison with soy protein isolate on appetite and calorie intake، anthropometric and metabolic indices, inflammatory and oxidative stress factors in healthy overweight and obese men
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria:Healthy interested men between ages 30 to 65;BMI=25 to 40kg/m2; No usage of cigarette or drugs or alcohol; No usage of antioxidants; no usage of decreasing blood pressure drugs, decreasing blood lipids or decreasing blood glucose drugs; No usage of antioxidants, gain or lose weight supplements; No lose weight diets; No intake of high doses of caffeine during the last 3 months; No record of diabetes, high blood pressure, acute heart diseases or thyroid/kidney/liver diseases, blood disorders,infarction or other clinical problems increasing oxidative stress like injuries or sever burnings; No allergy to cow milk or soy; No sever weight change during the last month, No usage of drugs affecting body weight ( Hormones or antidepression drugs), Exclusion Criteria: Altering the activity levels or diets in comparison with the ones before the study; Compliance less than 70%
Age
From 30 years old to 65 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences, School of Public health
Street address
School of Public Health , No 52,Alvand Avenue, Arjantin Square
City
Tehran
Postal code
1516846514
Approval date
2012-01-16, 1390/10/26
Ethics committee reference number
90-03-27-13475-43649

Health conditions studied

1

Description of health condition studied
Obesity and Overweight
ICD-10 code
E65,E66,E6
ICD-10 code description
Obesity and other hyperalimentation

Primary outcomes

1

Description
Body composition
Timepoint
Before and at the end of the first, second and the third month of the intervention
Method of measurement
Body composition analysis device

2

Description
Body weight
Timepoint
Before and after the intervention and every two weeks
Method of measurement
Scale

3

Description
Appetite
Timepoint
Before and after the intervention and weekly reports
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Blood pressure
Timepoint
Before and after the intervention and every two weeks
Method of measurement
Mercury Barometer

2

Description
Serum Lipids Profile
Timepoint
Before and after intervention
Method of measurement
Autoanalyzer

3

Description
MDA
Timepoint
Before and after the intervention
Method of measurement
Autoanalyzer

4

Description
HS CRP
Timepoint
Before and after the intervention
Method of measurement
Autoanalyzer

5

Description
Glucose
Timepoint
Before and after the intervention
Method of measurement
Autoanalyzer

Intervention groups

1

Description
Intervention Whey Protein Group: Whey Protein Isolate ,90%, 60 grams per day 30 minutes before lunch for 12 weeks
Category
Prevention

2

Description
Intervention Soy Protein Group: Soy Protein Isolate ,90%, 60 grams per day 30 minutes before lunch for 12 weeks
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran University of Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Vafa
Street address
School of Public Health, No 52, Alvand Avenue, Arjantin Square
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Central Building of Tehran University of Medical Sceinces, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Vafa
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, No 52,Alvand Avenue, Arjantin Square
City
Tehran
Postal code
Phone
+98 21 8877 9119
Fax
Email
mrvafa@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Vafa
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, No 52, Alvand Avenue,Arjantin Square
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
mrvafa@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Vafa
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health No 52,Alvand Avenue, Arjantin Square
City
Tehran
Postal code
Phone
+98 21 8877 9119
Fax
Email
mrvafa@tums.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
Loading...