Evaluation and comparison of the effect of Alternate Day Fasting and Low Calorie Diet on basal metabolic rate and body composition in overweight and obese individuals
1) Comparison of the situation of body composition and basal metabolic rate in two groups before and after the study.
2) Comparison of change in glucose, serum insulin and lipid profile in two groups before and after the intervention.
Design
This clinical trial with two intervention groups was performed in parallel, without randomized and blinded, on 100 patients.
Settings and conduct
Place of study at Imam Reza Hospital in Mashhad.
Both groups were measured and evaluated before and after the study by indirect calorimetry, the metabolic energy of the base and with the bio-impedance analysis apparatus of their body composition.
During a weekly study, a 24-hours recall is taken once a week.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Male and female both sexes
2) Age between 18 and 40 years
3) BMI≥25 and less than 40
4) weight stability for 3 months before study
5)Have no history of gastric surgery
6) Have not consumed medicines for weight loss in last 6 months
7) Based on the acknowledgment of the participants, no history of diabetes, hypertension, cardiovascular diseases, liver and kidney disorders, thyroid and lipid dysfunction or do not consume drugs related to these diseases
Non-entering study criteria:
1) pregnancy and lactation
2) suffering from a diseases that can eliminate the possibility of a low calorie diet and fasting diet
Intervention groups
We have two groups in this study.
The first group is the Alternate Day Fasting that will receive 24 hours a very low calorie diet(25 to 30 % of total daily energy) and 24 hours later an isocaloric diet.
The second group is a Low Calorie Diet that will received a normal weight loss diet.( 25% decrease in total daily energy).
The duration in two groups was 8 weeks.
Main outcome variables
Body composition, Basal metabolic rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200614047765N1
Registration date:2020-06-27, 1399/04/07
Registration timing:registered_while_recruiting
Last update:2020-06-27, 1399/04/07
Update count:0
Registration date
2020-06-27, 1399/04/07
Registrant information
Name
Afrouz Pishbin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3830 6808
Email address
pishbina961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the effect of Alternate Day Fasting and Low Calorie Diet on basal metabolic rate and body composition in overweight and obese individuals
Public title
Evaluation and comparison of the effect of Alternate Day Fasting and Low Calorie Diet on basal metabolic rate and body composition in overweight and obese individuals
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 45 years old
BMI ≥ 25 and less than 40
Weight stability for 3 months before the start of study (no more than 3kg decreased or increased weight)
Have no history of gastric surgery
In the last six months, they have not used medicine to reduce weight
Based on the acknowledgement of participants, diabetes, hypertension, cardiovascular disease, liver and kidney disorders and lipid disorders and thyroid problems are not, or do not consume drugs related to these diseases
Exclusion criteria:
The diseases that eliminate the possibility of a low-caloric or fasting diet in an individual
Pregnancy and lactation
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Mashhad University of Medical Sciences
Street address
No. 145, 12 Hamedi alley., Amirkabir Blvd., Shiraz Town
City
Shiraz
Province
Fars
Postal code
7175715973
Approval date
2019-01-01, 1397/10/11
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.730
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
Body composition
Timepoint
Before the beginning of the study and after the end of eighth week
Method of measurement
Inbody 770 Body Composition Analyzer
2
Description
Basal Metabolic Rate
Timepoint
Before the beginning of the study and after the end of eighth week
Method of measurement
Indirect calorimetry using Metalyzer 3B-R3 (German Cortex company)
Secondary outcomes
1
Description
Fasting blood glucose
Timepoint
Before the study and after the end of the eighth week
Method of measurement
Blood test
2
Description
Serum insulin
Timepoint
Before the study and after the end of the eighth week
Method of measurement
Blood test
3
Description
Lipid profile
Timepoint
Before the study and after the end of the eighth week
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: Get the Alternate Day Fasting diet in this group.During the 24 hours a very low calorie diet(25 to 30% of total daily energy) is received and 24 hours later they receive an isocaloric diet. The process continues intermittently for 8 weeks.
Category
Treatment - Other
2
Description
Control group: Receiving Low Calorie Diet in this group, they receive a normal weight loss diet (25% reduction of total daily energy) every day. The study period in this group is 8 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reaza hospital
Full name of responsible person
Mohsen Nematy
Street address
East door of Ferdowsi University, Public Relation Department of the University
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7034
Email
pishbina961@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Nematy
Street address
East door of Ferdowsi University, Public Relation Department of University
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7034
Email
Pishbina961@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Afruz Pishbin
Position
M.Sc Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
East door of Ferdowsi University, Public Relation Department of the University
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7034
Email
pishbina961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Afrouz Pishbin
Position
M.Sc Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 145, 12/5 Hamedi Alley, Amirkabir Blvd
City
Shiraz
Province
Fars
Postal code
7175715973
Phone
+98 71 3830 6808
Fax
Email
pishbina961@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Afrouz Pishbin
Position
M.Sc Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 145, 12/5 Hamedi Alley, Amirkabir Blvd
City
Shiraz
Province
Fars
Postal code
7175715973
Phone
+98 71 3830 6808
Fax
Email
pishbina961@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All information and data obtained will be published as an article
When the data will become available and for how long
Six month after the article was published
To whom data/document is available
All people who need information
Under which criteria data/document could be used
All people who need information
From where data/document is obtainable
pishbina961@mums.ac.ir
What processes are involved for a request to access data/document
The request is sent with the following email in the first opportunity to email data file