This RCT was aimed to evaluate the effect of meal timing on weight-loss diet effectiveness in overweight/obese subjects.
Design
An open labelled, parallel groups, randomised controlled clinical trial
Settings and conduct
This study will be conducted with the participation of the employees of Ahvaz Jundishapour University of Medical Sciences. To education and readiness of participants for the nutritional and behavioural alterations, they will be followed a weight loss diet for two weeks without meal timing limitation. participants will be assigned randomly into two groups including intervention and control. participants of each group will be followed a weight-loss diet for 4 weeks. The macronutrients distribution of the weight-loss diet will be the same for groups as follows: 53% carbohydrate 30% fat and 17% protein.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 30 to 60, body mass index (BMI) >25 kg/m2 and willingness to participate in the study. The exclusion criteria were consisted: pregnancy and lactation, chronic disease (such as cancer, liver and kidney disease), thyroid disease, gastrointestinal diseases, surgery for weight loss and any weight loss over the past six months, smoking, taking herbal supplements, weight-loss drugs and drug abuse
Intervention groups
A limited meal timing weight-loss diet group
A non-limited meal timing weight-loss diet group
Main outcome variables
Body weight and body mass index (BMI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131125015542N3
Registration date:2019-08-26, 1398/06/04
Registration timing:retrospective
Last update:2019-08-26, 1398/06/04
Update count:0
Registration date
2019-08-26, 1398/06/04
Registrant information
Name
Maryam Asadi
Name of organization / entity
Ahvaz jundi shapoor university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8253
Email address
maryamasadi136@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-18, 1396/07/26
Expected recruitment end date
2018-03-13, 1396/12/22
Actual recruitment start date
2017-11-12, 1396/08/21
Actual recruitment end date
2018-04-24, 1397/02/04
Trial completion date
2018-04-30, 1397/02/10
Scientific title
The effect of meal timing on weight-loss diet effectiveness in overweight/obese subjects: a randomized clinical trial
Public title
evaluation of meal timing on weight-loss diet effectiveness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
body mass index (BMI) >25 kg/m2
willingness to participate in the study
age between 30 to 60
Exclusion criteria:
pregnancy and lactation
chronic disease (such as cancer, liver and kidney disease)
thyroid diseases
gastrointestinal diseases
surgery for weight loss and any weight loss over the past six months
smoking
taking herbal supplements
weight-loss drugs
drug abuse
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization was done by the computer-generated random numbers
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 jundishapoor University of Medical Sciences
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2019-05-19, 1398/02/29
Ethics committee reference number
IR.AJUMS.REC.1398.179
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
2
Description of health condition studied
Overweight
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified
Primary outcomes
1
Description
Body weight
Timepoint
Baseline, week 2, week 4, week 6
Method of measurement
Scale
2
Description
Body mass index
Timepoint
Baseline, week 2, week 4, week 6
Method of measurement
Weight to square of height in meter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: meal timing weight loss diet group. The intervention group will be followed a standard weight loss diet for 4 weeks and the last daily meal will be up to 6 PM.
Category
N/A
2
Description
Control group: non-meal timing weight loss diet group. The control group will be followed a standard weight loss diet without meal timing for 4 weeks.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Nutrition and Metabolic Diseases Research Centre of Ahvaz Jundishapour University of Medical Science
Full name of responsible person
Anahita Mansoori
Street address
Golestan st.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 7777 7777
Email
Mansoori_anahita@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mohammad Badavi
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
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
Maryam Asadi
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 617777777
Email
maryamasadi136@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Anahita Mansoori
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 98617777777
Email
mansoori_anahita@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Asadi
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 617777777
Email
maryamasadi136@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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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