The effect of high protein snack replacement by low protein snack in regulating dietary intake, appetite, body composition and anthropometric indices of normal weight obese female
The aim of the present study is to compare the effect of high protein to low protein snack meals on appetite, anthropometry indices, body composition and dietary intake in normal weight obese women.
Design
A randomized, double-blinded clinical trial with a parallel group design of 120 participants, enrolled between October 2018 and September 2019, and followed for 6 months
Settings and conduct
The participants who met the inclusion and exclusion criteria were randomly assigned to either the high protein content snacks or low protein content snacks group, using a convenience allocation. The participants and researchers were unaware of the allocation of the two meal plan.
Participants/Inclusion and exclusion criteria
healthy, none-menopause female, having a body mass index (BMI) <25 and >18.5, body fat > 30 %
Intervention groups
high protein snack group: an instruction with a high protein content snacks (50 grams of soybeans)
low protein content snacks: an instruction with a low protein content snacks (fruits from the exchange list)
Main outcome variables
Body weight
percentage of body fat
Fat mass
Lean mass
Waist circumference
waist to hip ratio (WC/hip)
appetite
dietary intake
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170412033393N3
Registration date:2019-10-31, 1398/08/09
Registration timing:retrospective
Last update:2019-10-31, 1398/08/09
Update count:0
Registration date
2019-10-31, 1398/08/09
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
2018-09-21, 1397/06/30
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
2018-10-22, 1397/07/30
Actual recruitment end date
2019-02-19, 1397/11/30
Trial completion date
2019-03-18, 1397/12/27
Scientific title
The effect of high protein snack replacement by low protein snack in regulating dietary intake, appetite, body composition and anthropometric indices of normal weight obese female
Public title
The effect of high protein snack replacement by low protein snack in nutritional status of normal weight obese female
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
healthy, none-menopause female
body fat > 30 %
aged between 20 to 60 years
having a BMI (in kg/m2) <25 and >18.5
Exclusion criteria:
Age
From 20 years old to 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
120
Actual sample size reached:
112
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 snack group or low protein snack group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants were unaware of the allocation of the two meal plan. The researchers were not aware of the type of meal plans and they delivered the instruction in sealed envelopes to participants.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz university of medical sciences
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2019-06-23, 1398/04/02
Ethics committee reference number
IR.SUMS.REC.1398.776
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
before and 6 months after intervention
Method of measurement
mechanical scale
2
Description
Fat body mass
Timepoint
before and 6 months after intervention
Method of measurement
BIA machine
3
Description
lean body mass
Timepoint
before and 6 months after intervention
Method of measurement
BIA machine
4
Description
calorie intake
Timepoint
before and 6 months after intervention
Method of measurement
24-hour dietary recall questionaire
Secondary outcomes
1
Description
appetite score
Timepoint
before and after 6 months intervention
Method of measurement
Visual analogue scale questionnaire
Intervention groups
1
Description
Intervention group: high protein snack group; an instruction with a high protein content snacks (50 grams of soybeans)
Category
Prevention
2
Description
Control group: low protein content snacks; an instruction with a low protein content snacks (fruits from the exchange list)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Clinic
Full name of responsible person
Neda Haghighat
Street address
Karim Khan Zand Blvd
City
Shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 3612 1000
Email
motahari@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Centeral buliding of Shiraz University of Medical Sciences, in front of Felestin avenue, Zand stree.
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3242 4127
Email
Ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz 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
Ghadir mother and child hospital
City
Shiraz
Province
Fars
Postal code
7144995377
Phone
+98 71 3227 9711
Email
neda.hag@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz 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
Ghadir mother and child hospital
City
Shiraz
Province
Fars
Postal code
7144995377
Phone
+98 71 3227 9711
Email
neda.hag@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz 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
Ghadir mother and child hospital
City
Shiraz
Province
Fars
Postal code
7144995377
Phone
+98 71 3227 9711
Email
neda.hag@gmail.com
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