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Intervention groups
#1
Intervention group: Receive a weight loss diet and probiotic supplement for 12 weeks, A weight loss diet (500 kcal less than the daily requirement and the composition of the prescribed diet was 55% carbohydrate, 30% fat and 15%protein) is prescribed for the patient and a probiotic supplement manufactured by the TAKGENE pharmaceutical company (containing 1.8 billion CFUs per capsule / Lactobacillus acidophilus, Bifidobacterium bifidum, Bifidobacterium lactis and Bifidobacterium) twice per day is prescribed for 12 weeks.
Intervention group: Receive a weight loss diet and probiotic supplement for 12 weeks, A weight loss diet (500 kcal less than the daily requirement and the composition of the prescribed diet was 55% carbohydrate, 30% fat and 15%protein) is prescribed for the patient and a probiotic supplement manufactured by the TAKGENE pharmaceutical company (Contains Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus casei, Bifidobacterium langum, 10 to 8 or 9 cfu per capsule) twice per day is prescribed for 12 weeks.
Intervention group: Receive a weight loss diet and probiotic supplement for 12 weeks, A weight loss diet (500 kcal less than the daily requirement and the composition of the prescribed diet was 55% carbohydrate, 30% fat and 15%protein) is prescribed for the patient and a probiotic supplement manufactured by the TAKGENE pharmaceutical company (containing 1.8 billion CFUsContains Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus casei, Bifidobacterium langum, 10 to 8 or 9 cfu per capsule / Lactobacillus acidophilus, Bifidobacterium bifidum, Bifidobacterium lactis and Bifidobacterium) twice per day is prescribed for 12 weeks.
گروه مداخله: دریافت رژیم کاهش وزن و مکمل پروبیوتیک به مدت 12 هفته , رژیم غذایی کاهش وزن (500 کیلوکالری کمتر از نیاز روزانه و با ترکیب 55 درصد کربوهیدرات 30 درصد چربی و 15 درصد پروتئین) برای بیمار تجویز می شود و مکمل پروبیوتیک ساخت شرکت دارویی تک ژن ( حاوی 1.8 بیلیون CFU در هر کپسول/ لاکتوباسیلوس اسیدوفیلوس، بیفیدوباکتریوم بیفیدوم، بیفیدوباکتریوم لاکتیس و بیفیدوباکتریوم لانگوم) دو عدد در هر روز به مدت 12 هفته تجویز می شود.
گروه مداخله: دریافت رژیم کاهش وزن و مکمل پروبیوتیک به مدت 12 هفته , رژیم غذایی کاهش وزن (500 کیلوکالری کمتر از نیاز روزانه و با ترکیب 55 درصد کربوهیدرات 30 درصد چربی و 15 درصد پروتئین) برای بیمار تجویز می شود و مکمل پروبیوتیک ساخت شرکت دارویی تک ژن ( حاوی لاکتوباسیلوس پلانتاروم، لاکتوباسیلوس رامنوسوس،لاکتوباسیلوس کازئی، بیفیدوباکتریوم لانگوم، 10 به توان 8 یا 9 cfu در هر کپسول) دو عدد در هر روز به مدت 12 هفته تجویز می شود.
گروه مداخله: دریافت رژیم کاهش وزن و مکمل پروبیوتیک به مدت 12 هفته , رژیم غذایی کاهش وزن (500 کیلوکالری کمتر از نیاز روزانه و با ترکیب 55 درصد کربوهیدرات 30 درصد چربی و 15 درصد پروتئین) برای بیمار تجویز می شود و مکمل پروبیوتیک ساخت شرکت دارویی تک ژن ( حاوی 1.8 بیلیون CFUلاکتوباسیلوس پلانتاروم، لاکتوباسیلوس رامنوسوس،لاکتوباسیلوس کازئی، بیفیدوباکتریوم لانگوم، 10 به توان 8 یا 9 cfu در هر کپسول/ لاکتوباسیلوس اسیدوفیلوس، بیفیدوباکتریوم بیفیدوم، بیفیدوباکتریوم لاکتیس و بیفیدوباکتریوم لانگوم) دو عدد در هر روز به مدت 12 هفته تجویز می شود.
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Endocrinology and Metabolism Research Institute
Full name of responsible person - Persian: پژوهشگاه علوم غدد و متابولیسم
Street address - English: Chamran Highway, Jalal Al-Ahmad Highway, Shariati Hospital, Fifth Floor, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Obesity and Eating Habits Research Center
Street address - Persian: بزرگراه چمران، بزرگراه جلال آل احمد, بیمارستان شریعتی, طبقه پنجم، پژوهشکده علوم غدد و متابولیسم دانشگاه علوم پزشکی تهران, مرکز تحقیقات چاقی و عادات غذایی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411713137
Phone: +98 21 8863 1298
Fax:
Email: sh_hasani@sina.tums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences
Name of organization / entity - Persian: پژوهشگاه علوم غدد و متابولیسم، دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Neda Mehrdad
Full name of responsible person - Persian: ندا مهرداد
Street address - English: Chamran Highway, Jalal Al-Ahmad Highway, near Shariati Hospital, Endocrinology and Metabolism Research Institute
Street address - Persian: بزرگراه چمران، بزرگراه جلال آل احمد, جنب بیمارستان شریعتی, پژوهشکده علوم غدد و متابولیسم
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411713137
Phone: +98 21 8863 1298
Fax:
Email: emri-research@tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences Name of organization / entity - Persian: پژوهشگاه علوم غدد و متابولیسم، دانشگاه علوم پزشکی تهران Full name of responsible person - English: Endocrinology and Metabolism Research InstituteNeda Mehrdad Full name of responsible person - Persian: پژوهشگاه علوم غدد و متابولیسمندا مهرداد Street address - English: Chamran Highway, Jalal Al-Ahmad Highway, near Shariati Hospital, Fifth Floor, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Obesity and Eating Habits Research Center Street address - Persian: بزرگراه چمران، بزرگراه جلال آل احمد, جنب بیمارستان شریعتی, طبقه پنجم، پژوهشکده علوم غدد و متابولیسم دانشگاه علوم پزشکی تهران, مرکز تحقیقات چاقی و عادات غذایی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1411713137 Phone: +98 21 8863 1298 Fax: Email: sh_hasaniemri-research@sina.tums.ac.irtums.ac.ir Web page address:
Protocol summary
Study aim
The aim of this study is to prepare and produce effective probiotic formulations in obese adults and to evaluate their effectiveness on anthropometric indices, lipid profile, glycemic control, liver enzymes, inflammatory factors and GLP1 hormone.
Design
Double-blind Randomized clinical trial (both patients and researchers) with a parallel group design.
Settings and conduct
From outpatients with obesity referred to the nutrition clinic of Shariati Hospital affiliated to Tehran University of Medical Sciences, 60 patients will be selected based on inclusion and exclusion criteria. Participants and researchers are unaware of the allocation of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken from patients at the beginning of the study and 12 weeks after the intervention.
Participants/Inclusion and exclusion criteria
This randomized clinical trial will be performed on 60 eligible obese adults. Subjects are randomly divided into one of two groups: supplements and placebo. The duration of the intervention is 3 months, and people take supplements or placebos in addition to a low-calorie weight loss diet. At the beginning and end of the study, people have blood and stool tests and are examined for anthropometric indicators and food intake (24-hour recall questionnaire).
Intervention groups
Intervention group: Probiotic supplement capsule made by Tak Gene Pharmaceutical Company, twice a day with low calorie diet (500 kcal less than the person energy need), for three months
Control group: Placebo, twice daily with low calorie diet (500 kcal less than the person energy need), for three months
Main outcome variables
Weight
Body Mass Index
Waist circumference and hip circumference
Intestinal microbiota
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090420001825N3
Registration date:2020-09-07, 1399/06/17
Registration timing:prospective
Last update:2021-04-08, 1400/01/19
Update count:1
Registration date
2020-09-07, 1399/06/17
Registrant information
Name
Shirin Hasani-Ranjbar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0076
Email address
sh_hasani@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-06, 1399/07/15
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness assessment of a probiotic supplement on weight control in obese adults: a double blind clinical trial
Public title
The effect of probiotic supplement on weight in obese people
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range: 20 to 55 years
Body mass index: 30 to 40 kg/m2
Interest in participating in the project
Exclusion criteria:
unwillingness to cooperate
pregnancy and lactation
smoking
cardiovascular disease (history of myocardial infarction and use of digoxin and warfarin)
renal disease (creatinine above 2 mg/dL and GFR less than 30 )
Liver disease (liver enzyme levels two and a half times normal)
inflammatory bowel disease such as colitis
diabetes
cancer
history of gastrointestinal surgery
use of antibiotics during the two months before the start of the study and during the study
taking multivitamin supplements during the study
common use of probiotics and prebiotics during the month before the start of the study
common use Anti-inflammatory drugs during the month before the start of the study
use of weight loss drugs in the last 3 months
history of special diet for weight loss in the last 3 months
history of mental illness
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization is performed in order to balance the number of samples assigned to each of the study groups. Web randomization (https://www.sealedenvelope.com) is used for this purpose. The number and characteristics of the participants are entered in the desired position and the individuals are randomly assigned to one of the two intervention and placebo groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants, researchers, and clinical caregivers were unaware that each participant in the study was in the main intervention group (receiving a probiotic supplement) or a placebo (without a probiotic). Supplements and placebos are packaged exactly the same and separated by code. Therefore, people cannot identify which group they belong to.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Endocrinology and Metabolism Research Institute afilliated to Tehran University
Street address
Chamran Highway, Jalal Al-Ahmad Highway, Shariati Hospital, Fifth Floor, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Obesity and Eating Habits Research Center
City
Tehran
Province
Tehran
Postal code
1411713137
Approval date
2019-03-07, 1397/12/16
Ethics committee reference number
IR.TUMS.EMRI.REC.1398.001
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
weight
Timepoint
Beginning and end of the intervention
Method of measurement
Digital scale
2
Description
Body mass index
Timepoint
Beginning and end of the intervention
Method of measurement
Formula
3
Description
Waist circumference and hip circumference
Timepoint
Beginning and end of the intervention
Method of measurement
Tape meter
Secondary outcomes
1
Description
Waist to hip ratio
Timepoint
Beginning and end of the intervention
Method of measurement
Formula
2
Description
fasting glucose blood
Timepoint
Beginning and end of the intervention
Method of measurement
Autoanalyzer
3
Description
insulin
Timepoint
Beginning and end of the intervention
Method of measurement
Eliza
4
Description
Total cholesterol
Timepoint
Beginning and end of the intervention
Method of measurement
Spectrophotometry
5
Description
HDL
Timepoint
Beginning and end of the intervention
Method of measurement
Spectrophotometry
6
Description
LDL
Timepoint
Beginning and end of the intervention
Method of measurement
Spectrophotometry
7
Description
TG
Timepoint
Beginning and end of the intervention
Method of measurement
Spectrophotometry
8
Description
Liver enzymes (ALT and AST)
Timepoint
Beginning and end of the intervention
Method of measurement
Colorimetric test
9
Description
hsCRP
Timepoint
Beginning and end of the intervention
Method of measurement
Eliza
10
Description
GLP1
Timepoint
Beginning and end of the intervention
Method of measurement
Eliza
11
Description
Intestinal microbiota
Timepoint
Beginning and end of the intervention
Method of measurement
Real-time polymerase chain reaction
Intervention groups
1
Description
Intervention group: Receive a weight loss diet and probiotic supplement for 12 weeks, A weight loss diet (500 kcal less than the daily requirement and the composition of the prescribed diet was 55% carbohydrate, 30% fat and 15%protein) is prescribed for the patient and a probiotic supplement manufactured by the TAKGENE pharmaceutical company (Contains Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus casei, Bifidobacterium langum, 10 to 8 or 9 cfu per capsule) twice per day is prescribed for 12 weeks.
Category
Treatment - Other
2
Description
Control group: Receive weight loss diet and placebo for 12 weeks, The usual weight loss diet (500 kcal less than the daily requirement and the composition of the prescribed diet was 55% carbohydrate, 30% fat and 15%protein) is prescribed for the patient and the placebo (containing maltodextrine and magnesium stearate) is prescribed in the same size and shape as supplements made by TAKGENE Pharmaceutical Company, twice per day for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Obesity Clinic of Shariati hospital
Full name of responsible person
Shirin Hasani-Ranjbar
Street address
Chamran Highway, Jalal Al-Ahmad Highway, Shariati Hospital, Fifth Floor, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Obesity and Eating Habits Research Center
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8822 0038
Email
sh_hasani@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences
Full name of responsible person
Neda Mehrdad
Street address
Chamran Highway, Jalal Al-Ahmad Highway, near Shariati Hospital, Endocrinology and Metabolism Research Institute
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 21 8863 1298
Email
emri-research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrinology and Metabolism Research Institute, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hanieh-Sadat Ejtahed
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Chamran Highway, Jalal Al-Ahmad Highway, Shariati Hospital, Fifth Floor, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Obesity and Eating Habits Research Center
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 21 8822 0038
Fax
Email
haniejtahed@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shirin Hasani-Ranjbar
Position
Professor of Endocrinology & Metabolism
Latest degree
Ph.D.
Other areas of specialty/work
Endocrine
Street address
Chamran Highway, Jalal Al-Ahmad Highway, Shariati Hospital, Fifth Floor, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Obesity and Eating Habits Research Center
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 21 8822 0038
Email
sh_hasani@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hanieh Malmir
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Chamran Highway, Jalal Al-Ahmad Highway, Shariati Hospital, Fifth Floor, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Obesity and Eating Habits Research Center
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 21 8822 0076
Email
hanieh.malmir@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available