The aim of this study was to evaluate the effect of flaxseed powder on weight, appetite and appetite hormones and mental fatigue in overweight and obese children aged 7-18 years.
Design
Two arm parallel group randomized, controled trial (Study phase: 3)
sample size: 70
Settings and conduct
Seventy eligible children were selected based on available sampling from Shiraz health centers. Subjects were randomly divided into intervention and control groups by drawing method. At the beginning of the study, blood samples were taken to determine the amount of appetite control hormones and the appetite questionnaire, mental fatigue was completed. Then, flaxseed and puffed wheat (control) were distributed for 4 weeks. After 4 weeks, blood samples were taken again and the appetite and mental fatigue questionnaires were completed. Also, 24-hour food intake was taken at the beginning and at the end of the study to control and consider Disturbing edible variables.
Participants/Inclusion and exclusion criteria
The participants were children aged 7-18 years that had overweight and obesity. The inclusion criteria included the healthiness of these participants and their willingness to cooperation. Non-inclusion criteria:Children who had a particular diet.
Children who used flaxseed for at least a week ago.
Children who have been given supplementation or an appetite suppressant drug.
Intervention groups
The intervention group used 20 grams of flaxseed powder on yogurt, salad and food each day for 4 weeks.
The control group used 25 grams of puffed wheat each day for 4 weeks.
The intervention and control had the same calories.
Main outcome variables
The majer outcomes of this study included weight, appetite, appetite hormone (PPYY), and mental fatigue in overweight and obese children aged 7-18 years.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190408043204N1
Registration date:2019-04-28, 1398/02/08
Registration timing:retrospective
Last update:2019-04-28, 1398/02/08
Update count:0
Registration date
2019-04-28, 1398/02/08
Registrant information
Name
Zohreh Gholami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3754 5024
Email address
gholami_z@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
2018-12-22, 1397/10/01
Actual recruitment end date
2019-01-30, 1397/11/10
Trial completion date
2019-03-16, 1397/12/25
Scientific title
Effect of powder of flaxseed on weight, appetite, appetite hormones, and mental fatigue of Overweight and obesity children aged 7 to 18 years
Public title
Effect of flaxseed in improvement of appetite and mental fatigue
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy overweight and obesity children aged 7 to 18 years
Tendency to cooperate
Exclusion criteria:
Children who had a particular diet.
Children who used flaxseed for at least a week ago.
Children who have been given supplementation or an appetite suppressant drug.
Age
From 7 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Drawing method: Initially, we categorized the participants into four groups: obese children, overweight children, obese adolescents and overweight adolescents. Then, by using the drawing method, we randomized each group for allocation to either intervention or control group; In the drawing, individuals are allocated into intervention group for even times and into control for odd times.
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 Shiraz University of Medical Sciences
Street address
Street Zand, opposite Felestin Street, Central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2018-02-07, 1396/11/18
Ethics committee reference number
IR.SUMS.REC.1396.172
Health conditions studied
1
Description of health condition studied
Overweight and obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Weight in kilograms
Timepoint
At first (before intervention) and end (after 4 weeks of intervention) of study
Method of measurement
Digital scales by accuracy of 0.1 kilograms
Secondary outcomes
1
Description
Appetite questionnaire score
Timepoint
At first (before intervention) and end (after 4 weeks of intervention) of study
Method of measurement
Simple Appetite Questionnaire (8 Questions)
2
Description
Appetite hormone (PPYY)
Timepoint
At first (before intervention) and end (after 4 weeks of intervention) of study
Method of measurement
PPYY hormone measuring kit
3
Description
Mental fatigue score
Timepoint
At first (before intervention) and end (after 4 weeks of intervention) of study
Method of measurement
Multidimensional Fatigue Inventory (MFI)
Intervention groups
1
Description
Intervention group: This group consumed 20 grams of flaxseed each day for four weeks in full powder form.
Category
Prevention
2
Description
Control group: This group consumed 25 grams of puffed wheat each day for 4 weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Health Center (Valfajar)
Full name of responsible person
Zohreh Gholami
Street address
West Saheli Street, Next to the Governorate
City
Shiraz
Province
Fars
Postal code
71357-66563
Phone
+98 71 3234 0884
Email
gholami_z@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoumeh Akhlaghi
Street address
Street Zand, Opposite Flestine Street, Central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Web page address
Grant name
sg- Grant of Shiraz University of Medical Sciences
Grant code / Reference number
sg -گرنت 39- 96
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
Masoumeh Akhlaghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Razi Blvd, School of Nutrition and Food sciences
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
msm.akhlaghi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoumeh Akhlaghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Razi Blvd, School of Nutrition and Food Sciences
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
msm.akhlaghi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zohreh Gholami
Position
Master student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Razi Blvd, School of Nutrition and Food Sciences
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3754 5024
Email
gholami_z@sums.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
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