The purpose of this study is comparison between replacement of diet soda with water on weight loss in obese and overweight healthy women. This study is parallel randomized clinical trials. Sixty participant with Body Mass Index 27-35 kg/m2 and age 18-50 years that consumes at least 250 calories per day (4-5 days/ week) from caloric beverages will are selected. Participants involving weight loss or physical activity in the previous 6 months, Additionally, report current participating in any other research studies whose results could be compromised by or in which participation could compromise this research study, report pregnancy or lactation, during the previous 6 months, or planned pregnancy in the next 6 months, report taking medication that could affect metabolism or change body weight report heart problems, chest pain, cancer within the last 5 years, unwilling to change intake of beverages during the study period will be exclude. Participants will be randomly divided in two groups: 1) substitute water for diet soda or 2) continue drinking diet soda five times per week. Subjects’ weight are assessed before, after 12, 24 and 77 weeks of study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402177754N5
Registration date:2014-03-11, 1392/12/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-03-11, 1392/12/20
Registrant information
Name
Leila Shafiei Neek
Name of organization / entity
Faculty of Physical Education and Sport Sciences, University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 2258 9952
Email address
shafieineek@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Novin Diet Clinic
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between replacement of diet beverage soft drinks with water on weight loss in obese and overweight healthy women.
Public title
Effects of replacement of diet beverage soft drinks with water on promoting weight reduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: 18-50 years of age; Body mass index between 27-35 kg/m2; Subject consumes at least 250 calories per day (4-5 days/ week) from caloric beverages.
Exclusion Criteria:Report participating in a research project involving weight loss or physical activity in the previous 6 months; Additionally, report current participating in any other research studies whose results could be compromised by or in which participation could compromise this research study; report pregnancy or lactation; during the previous 6 months, or planned pregnancy in the next 6 months; report taking medication that could affect metabolism or change body weight report heart problems; chest pain, cancer within the last 5 years;
unwilling to change intake of beverages during the study period.
Age
From 18 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
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 Digestive Disease Reaserch Institute
Street address
Shariati Hospital., North Kargar Ave.
City
Tehran
Postal code
Approval date
2014-01-28, 1392/11/08
Ethics committee reference number
FWA00001331
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Weight
Timepoint
first, after 12 , 24, 77 weeks
Method of measurement
scale
Secondary outcomes
1
Description
Carbohydrate metabolism
Timepoint
first, after 12 , 24, 77 weeks
Method of measurement
Blood testing
2
Description
Cardiometabolic risk factors
Timepoint
first, after 12 , 24, 77 weeks
Method of measurement
Blood testing
Intervention groups
1
Description
in first group, water are replaced with diet soda and will follow a low calorie diet (Novin Diet protocol).
Category
Behavior
2
Description
second group continued to receive the diet soda and will follow a low calorie diet (Novin Diet protocol).
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Novin Diet Clinic
Full name of responsible person
Dr. Haminreza Farshchi
Street address
No 5., 4th Floor., Nikan Bldg., Shariati Ave.,
City
Teharan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Novin Diet Clinic
Full name of responsible person
Dr. Hamidreza Farshchi
Street address
No.5, 4th Floor, Nikan Bldg, Shariati Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Novin Diet Clinic
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Novin Diet Clininc
Full name of responsible person
Dr.Seyedeh Ameneh Majd
Position
Pharmacologist
Other areas of specialty/work
Street address
No.5, 4th Floor, Nikan Bldg, Shariati Ave
City
Tehran
Postal code
Phone
+98 21 2226 3002
Fax
Email
amameneh@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Novin Diet Clininc
Full name of responsible person
Dr.Hamidreza Farshchi
Position
Clinical Nutritionist & Metabolism
Other areas of specialty/work
Street address
No.5, 4th Floor, Nikan Bldg, Shariati Ave
City
Tehran
Postal code
Phone
+98 21 2226 3002
Fax
Email
hrfarshchi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Novin Diet Clinic
Full name of responsible person
Leila Shafiei Neek
Position
PhD student of exercise physiology
Other areas of specialty/work
Street address
No. 5, 4th Floor, Nikan Bldg, Shariati Ave
City
Tehran
Postal code
Phone
+98 21 2226 3002
Fax
Email
shafieineek@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)