Comparison of the effect of Modified Intermittent Fasting Diet and Daily Calorie Restriction Diet on sleep quality and anthropometric indices of obese and/or overweight adult women 18 to 50 years
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General information
2022-08-01, 1401/05/10
2022-09-01, 1401/06/10
2022-0809-01 00:00:00
2022-08-30, 1401/06/08
2022-12-30, 1401/10/09
2022-0812-30 00:00:00
Protocol summary
Study aim
omparison of the effect of modified intermittent fasting diet and daily calorie restriction diet on sleep quality and anthropometric indices of obese or overweight adult women 18 to 50 years
Design
This is a randomized, controlled, parallel-group trial. Participants will be stratified using stratified randomization based on age and BMI. Then using the random numbers table are assigned to one of the two groups intervention and control. Because it is a diet intervention, it is not blinding. The trial phase is not applicable.
Settings and conduct
Participants are selected from the Health Centers of Kashan University of Medical Sciences by convenient sampling. Participants are randomly assigned into two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women in the age range of 18 to 50 years and body mass index greater than or equal to 25 and less than 40.
Exclusion criteria: pregnancy, lactation, chronic diseases such as hypertension, heart disease, diabetes, gastrointestinal disorders such as gastritis, gastric and duodenal ulcers, Smoking habits, alcoholism, weight loss of 1 to 2 kg in the past month, following a special diet or taking certain medications, taking dietary supplements, having a mental disorder
Intervention groups
Intervention: The energy requirements for the individuals calculate using the Mifflin equation. It involves alternating periods of feeding and fasting, on an every-other-day basis. Fasting day only comprises 25% of the recommended calorie intake. On feeding days, the participants are provided foods at 100% of calculated daily energy requirements.
control: The energy requirements for the individuals calculate using the Mifflin equation. subjects consume 63% of their energy requirement each day.
Main outcome variables
The sleep quality؛ daytime sleepiness؛ insomnia؛ BMI؛ FFM؛ and the body fat mass
General information
Reason for update
Due to the delay in the recruitment dates, we request to change the expected recruitment start date.
Acronym
IRCT registration information
IRCT registration number:IRCT20220522054958N3
Registration date:2022-07-08, 1401/04/17
Registration timing:prospective
Last update:2022-07-30, 1401/05/08
Update count:4
Registration date
2022-07-08, 1401/04/17
Registrant information
Name
Saeedeh Hosseini hooshiar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5558 9024
Email address
shoseinih3322@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-01, 1401/06/10
Expected recruitment end date
2022-12-30, 1401/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Modified Intermittent Fasting Diet and Daily Calorie Restriction Diet on sleep quality and anthropometric indices of obese and/or overweight adult women 18 to 50 years
Public title
The effect of Modified Intermittent Fasting Diet on sleep quality and anthropometric indices of obese and/or overweight adult women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
women in the age range of 18 to 50 years
BMI more than or equal to 25 and less than 40
Exclusion criteria:
pregnancy
breastfeeding
Chronic diseases such as high blood pressure, heart disease, diabetes, gastrointestinal disorders such as gastritis, peptic ulcer and duodenal ulcer
the habit of smoking
alcohol abuse
weight loss of 1 to 2 kg in the past month
following a specific diet or taking a specific medication
taking dietary supplements
Having mental disorders
Having overnight shifts
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects are selected by a convenient sampling method. Then, participants are divided into groups of control and intervention by simple randomization and using the random numbers table. The randomization method is that at the beginning, it is agreed to give the intervention group the odd number and the control group the even number. Therefore, participants are assigned to the control or intervention group depending on whether we reach the odd or even number in the random numbers table. Randomization is individual.
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
Faculty of Medicine and Dentistry - Kashan University of Medical Sciences (Research Ethics Committee
Street address
5 km Qutb Ravandi Boulevard, Kashan University of Medical Sciences, Vice Chancellor for Research
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2022-04-17, 1401/01/28
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1401.002
Health conditions studied
1
Description of health condition studied
overweight
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Obesity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sleep quality
Timepoint
The beginning and end of the study
Method of measurement
Pittsburgh Sleep Quality questionnaire
2
Description
daytime sleepiness
Timepoint
The beginning and end of the study
Method of measurement
Epworth Sleepiness questionnaire
3
Description
Insomnia
Timepoint
The beginning and end of the study
Method of measurement
Insomnia Severity questionnaire
4
Description
BMI
Timepoint
The beginning and end of the study
Method of measurement
Height: stadiometer, Weight: scale
5
Description
Free fat mass FM and the body fat mass
Timepoint
The beginning and end of the study
Method of measurement
Inbody Device
6
Description
The body fat mass
Timepoint
The beginning and end of the study
Method of measurement
Inbody Device
7
Description
waist circumference
Timepoint
The beginning and end of the study
Method of measurement
non-stretchable measuring tape
8
Description
The waist-to-hip ratio
Timepoint
The beginning and end of the study
Method of measurement
by dividing the waist circumference by the hip circumference
Secondary outcomes
1
Description
The hip circumference
Timepoint
The beginning and end of the study
Method of measurement
non-stretchable measuring tape
2
Description
visceral fat area
Timepoint
The beginning and end of the study
Method of measurement
Inbody device
3
Description
The percent body fat
Timepoint
The beginning and end of the study
Method of measurement
Inbody device
4
Description
The soft lean mass
Timepoint
The beginning and end of the study
Method of measurement
Inbody device
5
Description
The skeletal muscle mass
Timepoint
The beginning and end of the study
Method of measurement
Inbody device
6
Description
the extracellular water ratio
Timepoint
The beginning and end of the study
Method of measurement
Inbody device
7
Description
The total body water
Timepoint
The beginning and end of the study
Method of measurement
Inbody device
Intervention groups
1
Description
Intervention group: The energy requirements for the individuals calculate using the Mifflin equation. Then, alternately, one day 25% of the energy and the next day 100% of the required energy is provided. On fasting days, one can get 25% of the daily calories needed from 12 noon to 2 pm. This diet is followed for 8 weeks.
Category
Prevention
2
Description
Control group: The energy requirements for the individuals calculate using the Mifflin equation. subjects consume 63% of their energy requirement each day. This diet is followed for 8 weeks.