Protocol summary

Study aim
The aim of this study is to investigate the effect of high protein diet and standard protein on appetite status, body weight, body mass index (BMI), fat mass (FM) and lean body mass (LBM) in normal obese women.
Design
Design: In this randomized controlled trial, the participants randomly will be assigned to 2 groups. 25 women will be allocated in the control group to receive a diet regimen with a standard protein content (standard protein (SP); providing 0.8 g/kg body weight/day), and 25 women will be allocated in the intervention group to receive a diet regimen with a higher protein content (high protein (HP); providing 1.2 g/kg body weight/day) for 12 weeks. The diet regimens have an equal amount of calories in both groups according to the resting metabolic rate (BMR) based on the Harris-Benedict predictive formula.
Settings and conduct
The participants will not know whether they are a member of the HP group or the SP group.
Participants/Inclusion and exclusion criteria
Inclusion criteria into the study are for healthy women, aged between 30 to 60 years having a BMI (in kg/m2) <25 and >18.5, body fat>30 %. Exclusion criteria include: smoking, pregnancy, lactation, history or presence of kidney, gastrointestinal, liver, or thyroid disease, gout, certain cancers, or type 2 diabetes, severe weight changes within the last 3 months and bariatric surgery; recently following a high-protein diet or using anti-obesity medications or supplements; and consuming protein supplement and high amounts of caffeine (>250- 300 mg/d).
Intervention groups
high protein diet and standard protein
Main outcome variables
The weight, body composition including fat body mass and lean body mass by BIA machine and appetite level by visual analogue scale questionnaire will be measured before and after the trial.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170412033393N2
Registration date: 2019-04-06, 1398/01/17
Registration timing: retrospective

Last update: 2019-04-06, 1398/01/17
Update count: 0
Registration date
2019-04-06, 1398/01/17
Registrant information
Name
Neda Haghighat
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 705 0021
Email address
haghighat.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-21, 1397/02/31
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
2018-05-21, 1397/02/31
Actual recruitment end date
2019-01-20, 1397/10/30
Trial completion date
2019-02-03, 1397/11/14
Scientific title
The effect of high protein diet in regulating appetite, anthropometric indices, and body composition of Normal Weight Obese women
Public title
High protein diet in normal weight obese women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
healthy women having a body mass index (kg/m2) <25 and >18.5 body fat>30 % aged between 30 to 60 years
Exclusion criteria:
Age
From 30 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
Actual sample size reached: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Participants divide into two groups randomly. Randomization will be carried out by means of a random number table; for this, an independent coordinator creates the randomization list assigning participants to the high protein diet group or standard protein diet group.
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
Ethics committee of Ahvaz university of medical sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Ethics Committee
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2017-03-13, 1395/12/23
Ethics committee reference number
IR.AJUMS.REC.1395.55

Health conditions studied

1

Description of health condition studied
normal weight obesity
ICD-10 code
E66.8
ICD-10 code description
Other obesity

Primary outcomes

1

Description
weight
Timepoint
6 months
Method of measurement
mechanical scale

2

Description
Fat body mass
Timepoint
Before and after intervention
Method of measurement
BIA machine

3

Description
Lean body mass
Timepoint
Before and after intervention
Method of measurement
BIA machine

Secondary outcomes

1

Description
appetite score
Timepoint
before and after intervention
Method of measurement
Visual analogue scale questionnaire

Intervention groups

1

Description
Intervention group: high protein diet [high protein (HP); protein amount of 1.2 grams per kilogram body weight (gr/kg)]
Category
Lifestyle

2

Description
Control group: standard protein diet high protein diet [standard protein (SP); protein amount of 0.8 grams per kilogram body weight (gr/kg)]
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Obesity clinc
Full name of responsible person
Meysam Alipour
Street address
Golestan hospital
City
Ahvaz
Province
Khouzestan
Postal code
3311861357
Phone
+98 61 3374 1047
Email
Golestanhospital@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badavi
Street address
Vice chancellor for research, Ahvaz Jundishapur University of Medical Science, Ahvaz, Khouzestan
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Neda Haghighat
Position
Ph.D of Nutrition Science
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Dept of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science, Ahvaz, Khouzestan
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3373 8330
Email
haghighat.n@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Neda Haghighat
Position
PhD in nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Dept of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science,Golestan Ave, Ahvaz,Khouzestan
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3311
Email
neda.hag@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Neda Haghighat
Position
Ph.D. of nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Dept of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3311
Email
haghighat.n@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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