Comparison of the Effect of Milk and Pistachio on Satiety and Weight Changes in Women With Overweight or Obesity
Design
Randomized clinical trial: crossover
Settings and conduct
Ahwaz University of Medical Sciences
After obtaining a license، the participants were randomly divided into dairy groups and nuts and they are asked to eat food as sank between 10 and 10:30.The duration of the intervention is one month and the washout period will be two weeks.The day of filling in the questionnaire they are asked to have their routine daily activity and after having spent the usual breakfast at 8:00 in the morning before 9:00 AM, go to the research center.Before and after taking milk and pistachio as a snack and every half hour, using the visual analogue questionnaire, the status of satiety will be determined.Weight variations are measured at the beginning and at the end of each intervention.
Participants/Inclusion and exclusion criteria
Inclusion:Body mass index over 25- age 18 to 55 years
exclusion:Pregnancy -Lactation -Drug use or diseases that affect metabolism-satiety and hunger-hate of milk and pistachios-The disease associated with milk and pistachios
Intervention groups
Group 1:Milk
Group2:Pistchio
Main outcome variables
satiety and weight change
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181024041448N1
Registration date:2018-11-06, 1397/08/15
Registration timing:registered_while_recruiting
Last update:2018-11-06, 1397/08/15
Update count:0
Registration date
2018-11-06, 1397/08/15
Registrant information
Name
leila sheikhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3837 7353
Email address
lsheikhy@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-04, 1397/08/13
Expected recruitment end date
2018-11-10, 1397/08/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Milk and Pistachio on Satiety and Weight Changes in Women With Overweight or Obesity
Public title
"Effect of Milk and Pistachio on Satiety and Weight"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Body Mass Index(BMI): higher than 25
Age:18 to 55 years old
Exclusion criteria:
Pregnancy
Lactation
Drug use and diseases that affect metabolism, hunger and satiety
Hate of milk and pistachio
Disease associated with milk and pistachios
Age
From 18 years old to 55 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
For randomization, lottery was used and the subjects were divided into two groups: 1 group of milk and 2 groups of pistachio group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
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
Golestan Blvd. Ahvaz Jundishapur University of Medical Sciences
City
Ahwaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2018-10-23, 1397/08/01
Ethics committee reference number
IR.AJUMS.REC.1397.529
Health conditions studied
1
Description of health condition studied
Satiety and Weight Changes
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Satiety
Timepoint
Satiety at the end of the intervention
Method of measurement
Visual Analogue Scale
2
Description
Weight Changes
Timepoint
Before and after the intervention
Method of measurement
Scales
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group1: Milk(200cc) as snack every day 10-10:30 AM for 1month/ Factory:Mahin
Category
Other
2
Description
Intervention Group2: 25 gr Pistachio as snack every day 10-10:30 AM for 1month
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Dormitory Jondishapoor University Of Medical Sciences Ahvaz
Full name of responsible person
Leila Sheikhi
Street address
Golestan Blvd. Ahvaz Jundishapur University Of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
Email
lsheikhy@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badvi
Street address
Golestan Blvd. Ahvaz Jundishapur University Of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Email
lsheikhy@yahoo.com
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
Leila Sheikhi
Position
MSc Nutrition Student, Ahwaz University of Medical Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan Blvd. Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 33311
Email
lsheikhy@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Leila Sheikhi
Position
MSc Nutrition Student, Ahvaz University of Medical Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan Blvd. Ahvaz Jundishapur University Of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 33311
Email
lsheikhy@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Leila Sheikhi
Position
MSc Nutrition Student, Ahwaz University Of Medical Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan Blvd. Ahvaz Jundishapur University Of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 33311
Email
lsheikhy@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available