Protocol summary
-
Study aim
-
Comparison the effect of taking yogurt enriched with probiotic and 25OHD3 and low calorie diet on satiety and hunger hormones and 25OHD3 in obese people
-
Design
-
A randomised, double blinded, controlled clinical trial with four parallel group design
-
Settings and conduct
-
This study will be conducted at health faculty. volunteers randomly will be allocated to one of the 4 groups by using 4 randomized blocks. Individuals will complete physical activity questionnaire (comparing physical activity pattern between 4 groups in the end of intervention), consent form and demographic information. Height will determined with a stadiometer to the nearest of 0.1 cm. Weight and body composition will measured by using body analyzer. After 12–14 h of fasting, venous blood samples will collected. In this study, factory will choose 4 different codes for 4 kind of yogurts instead of their names, therefore main researcher, participant and yogurt distributor will be blind from start to the end of study.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: Willingness to lose weight, Age between 18 and 60, BMI between 29 and 51, Filling the consent form, Absence of associated co-morbidities, Absence of breast-feeding, pregnancy or menopause, No history of hormone disorders, No intake of vitamin D for 1 months before the intervention. Non inclusion criteria includes: have allergy to yogurt, Using weight loss regimens
-
Intervention groups
-
The intervention groups including 3 group recieving probiotic yogurt and low calorie diet; probiotic yogurt enriched with 25OHD3 and low calorie diet; yogurt enriched with 25OHD3 and low calorie diet; traditional yogurt and low calorie diet
-
Main outcome variables
-
Changes in ghrelin, peptid YY, glucagon like peptid, 25OHD3 and anthropomorphic factors
General information
-
Reason for update
-
for filling out the date of finishing recruiting and clinical trial and
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20120525009856N7
Registration date:
2018-06-13, 1397/03/23
Registration timing:
prospective
Last update:
2019-12-30, 1398/10/09
Update count:
1
-
Registration date
-
2018-06-13, 1397/03/23
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2018-04-21, 1397/02/01
-
Expected recruitment end date
-
2018-05-20, 1397/02/30
-
Actual recruitment start date
-
2018-11-13, 1397/08/22
-
Actual recruitment end date
-
2018-12-10, 1397/09/19
-
Trial completion date
-
2019-04-06, 1398/01/17
-
Scientific title
-
Investigating the effect of probiotic and 25OHD3 with low-calorie diet on satiety and hunger hormones and vitamin D in obese people
-
Public title
-
Investigating the synergist effect of probiotic and vitamin D in obesity
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Willingness to lose weight
Age between 18 and 60
Body mass index (BMI) between 29 and 51
Filling the consent form of the present project
Absence of associated co-morbidities (insulin dependent diabetes, chronic kidney disease, cancer and anemia)
Absence of breast-feeding, pregnancy or menopause
No history of hormone disorders including: hypothyroid, hyperthyroid, polycystic ovary syndrome (PCOS), breast and ovary cyst
No intake of vitamin D for 1 months before the study initiation
No antibiotic treatment for the last 1 month
No intake of probiotic, prebiotic and synbiotic supplement and/ or probiotic, prebiotic and synbiotic enriched products 1 month before the study initiation
Exclusion criteria:
Individuals who had allergy to yogurt
Individuals who use certain regimens or weight loss regimens
Individuals who use any kind of vitamin supplements
Individuals who use any kind of weight loss drug or supplement
women who use contraceptive drugs
-
Age
-
From 18 years old to 60 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Investigator
- Data analyser
-
Sample size
-
Target sample size:
140
Actual sample size reached:
140
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Individual randomization with out layering, Four blocks randomized
Blocks will determined daily and write on paper
Selecting randomized blocks will done by somebody except researcher.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
The appearance of yogurts are the same
The main investigator will not be aware of yogurt's content and the group which subjects are in.
The person who analyze date will be unaware of the group which each subject belong.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2018-02-28, 1396/12/09
-
Ethics committee reference number
-
IR.KUMS.REC.1396.651
Health conditions studied
1
-
Description of health condition studied
-
Obesity
-
ICD-10 code
-
E66.9
-
ICD-10 code description
-
Obesity, unspecified
Primary outcomes
1
-
Description
-
25(OH)D3
-
Timepoint
-
In base line (before intervention) and 10 months after the beginning of intervention
-
Method of measurement
-
By using ELISA Kit
2
-
Description
-
Ghrelin hormone
-
Timepoint
-
In base line (before intervention) and 10 months after the beginning of intervention
-
Method of measurement
-
By using ELISA Kit
3
-
Description
-
Peptid YY hormone
-
Timepoint
-
In base line (before intervention) and 10 months after the beginning of intervention
-
Method of measurement
-
By using ELISA Kit
4
-
Description
-
GLP-1 hormone
-
Timepoint
-
In base line (before intervention) and 10 months after the beginning of intervention
-
Method of measurement
-
By using ELISA Kit
5
-
Description
-
Waist Circumference
-
Timepoint
-
In base line (before intervention) and 10 months after the beginning of intervention
-
Method of measurement
-
In term of centimeter by Tape measure
6
-
Description
-
Body Fat Mass
-
Timepoint
-
In base line (before intervention) and 10 months after the beginning of intervention
-
Method of measurement
-
in term of kg, by using body analyzer instrument
7
-
Description
-
Hip Circumference
-
Timepoint
-
In base line (before intervention) and 10 months after the beginning of intervention
-
Method of measurement
-
In term of centimeter by Tape measure
Secondary outcomes
1
-
Description
-
Serum LDL
-
Timepoint
-
before and after 10 weeks
-
Method of measurement
-
by using Friedewald equation
2
-
Description
-
Serum HDL
-
Timepoint
-
before and after 10 weeks
-
Method of measurement
-
by using biochemical kits (mono bind ELISA kit)
3
-
Description
-
serum fasting blood sugar
-
Timepoint
-
before and after 10 weeks
-
Method of measurement
-
by using biochemical kits (mono bind ELISA kit)
4
-
Description
-
serum total cholostrol
-
Timepoint
-
before and after 10 weeks
-
Method of measurement
-
by using biochemical kits (mono bind ELISA kit)
5
-
Description
-
serum Total triglycerides
-
Timepoint
-
before and after 10 weeks
-
Method of measurement
-
by using biochemical kits (Monobind ELISA kit)
Intervention groups
1
-
Description
-
The first intervention group: low calorie diet and 100 g/day yogurt enriched with 1000 IU 25OHD3
-
Category
-
Lifestyle
2
-
Description
-
The second intervention group: low calorie diet and 100 g/day probiotic yogurt enriched with 1000 IU 25OHD3
-
Category
-
Lifestyle
3
-
Description
-
The third intervention group: low calorie diet and 100 g/day probiotic yogurt
-
Category
-
Lifestyle
4
-
Description
-
The control group: low calorie diet and 100 g/day traditional yogurt.
-
Category
-
Lifestyle
1
-
Sponsor
-
-
Grant name
-
خالي
-
Grant code / Reference number
-
خالي
-
Is the source of funding the same sponsor organization/entity?
-
No
-
Title of funding source
-
Medical univercity of kermanshah
-
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
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
No - There is not a plan to make this available
-
Justification/reason for indecision/not sharing IPD
-
No more information
-
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