The effect of Lactobacillus rhamnosus, Lactobacillus fermentum and Lactobacillus plantarum on anthropometric indices and circulating level of metabolic parameters, oxidative stress and inflammatory biomarkers in obese individuals
Comparison the effect of Lactobacillus rhamnosus, Lactobacillus fermentum and Lactobacillus plantarum on anthropometric indices and circulating level of metabolic parameters, oxidative stress and inflammatory biomarkers in obese individuals
Design
A clinical trial with control group and four parallel groups of 20 obese women, randomized through www.sealedenvelope.com
Settings and conduct
People attending to the health centers in the city of Maragheh are invited to participate in this study. After having the consent to participate in this study, the address of Khajeh Nasir Nutrition Clinic will be given to them. All stages of research are done in that clinic. Patients who signed informed consent will be randomly divided into four groups. The first, second and third s will received Lactobacillus rhamnosus, Lactobacillus fermentum, Lactobacillus plantarum respectively and the control group will received placebo. The final outcome of the study will be assessed by a third party who is unaware of the study process. Also, the statistician will be unaware of the study process.
Participants/Inclusion and exclusion criteria
Inclusion criteria included obese women in the range of body mass index (BMI ≤ 40), age group 18-60 years
Exclusion criteria: in the last two months, having a special diet to treat obesity,
Intervention groups
group1:Probiotic supplement in powder sacs containing Lactobacillus fermentum 014 NIMBB (NCBI MT registration code 994667) isolated from the ridge (for 60 days)
Group2:Lactobacillus rhamnosus NIMBB006 (NCBI MT registration code 995144) isolated from breast milk at a rate of 2 * 10 cfu(for 60 days)
Group3: Lactobacillus plantarum isolated from camel milk (cfu 9 10 * 2 NCBI MT 012188)(for 60 days)
Control group: Placebo with tasteless maltodextrin 100 for 60 days(for 60 days)
Main outcome variables
Weight changes
General information
Reason for update
Acronym
PTO
IRCT registration information
IRCT registration number:IRCT20220608055106N1
Registration date:2022-07-03, 1401/04/12
Registration timing:prospective
Last update:2022-07-03, 1401/04/12
Update count:1
Registration date
2022-07-03, 1401/04/12
Registrant information
Name
Jamileh Ghalami
Name of organization / entity
The university of Alborz
Country
Iran (Islamic Republic of)
Phone
+98 26 3664 8761
Email address
s_ghalami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2023-08-01, 1402/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Lactobacillus rhamnosus, Lactobacillus fermentum and Lactobacillus plantarum on anthropometric indices and circulating level of metabolic parameters, oxidative stress and inflammatory biomarkers in obese individuals
Public title
Probiotics in the treatment of obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obese women in the range of body mass index( 30≤BMI ≤ 40)
Age group of 18-60 years
Exclusion criteria:
Allergy to probiotics
Diabetes and chronic illness
Having a special diet to treat obesity in the last two months
Taking certain medications and corticosteroids
Consumption of probiotics
Gastric surgery
Thyroid disorders
Age
From 18 years old to 60 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method with non-matched block size will be studied. For this purpose, a list of the order of allocation of samples by the second (non-original) researcher and using the software provided on the website https://www.sealedenvelope.com. Prepared and the size of the blocks will be two, four and six.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Ethics committee unit; Vice Chancellor for Research; No.20; Saffarian alley; 45 Metri Golshahr street
City
Tehran
Province
Tehran
Postal code
3149779453
Approval date
2022-05-21, 1401/02/31
Ethics committee reference number
IR.ABZUMS.REC.1401.054
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
Anthropometric indicators (height and weight, waist circumference and hip circumference)
Timepoint
The first day and two months later
Method of measurement
Meter
Secondary outcomes
1
Description
Serum level Total body antioxidant capacity (serum TAC level)
Timepoint
The first day and two months later
Method of measurement
Spectrophotometry and enzyme kit
2
Description
Reactive aldehyde active compound (serum MDA level)
Timepoint
The first day and two months later
Method of measurement
Flowmetry
3
Description
Serum level of IL-6
Timepoint
The first day and two months later
Method of measurement
Eliza
4
Description
Fasting blood sugar
Timepoint
The first day and two months later
Method of measurement
BT autoanalyzer device ( Biotecnica BT)
Intervention groups
1
Description
Intervention group: (group1) Probiotic supplement in powder sacs containing Lactobacillus fermentum 014 NIMBB (NCBI MT registration code 994667) isolated from the ridge (for 60 days)
Category
Treatment - Drugs
2
Description
Intervention group:(Group2) Lactobacillus rhamnosus NIMBB006 (NCBI MT registration code 995144) isolated from breast milk at a rate of 2 * 10 cfu (for 60 days)
Category
Treatment - Drugs
3
Description
Intervention group ( Group3) Lactobacillus plantarum isolated from camel milk (cfu 9 10 * 2 NCBI MT 012188)(for 60 days)
Category
Treatment - Drugs
4
Description
Control group: Placebo with tasteless maltodextrin 100 for 60 days(for 60 days)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khajeh Nasir al-Din Nutrition Clinic
Full name of responsible person
Jamileh Ghalami
Street address
Shahid Dastgheib St, Maragheh, East Azarbaijan,
City
Maragheh
Province
East Azarbaijan
Postal code
5515878151
Phone
+98 41 3723 1618
Email
s_ghalami@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Nourisepehr
Street address
Vice Chancellor for Research; No.20; Saffarian alley; 45 Metri Golshahr street
City
Tehran
Province
Tehran
Postal code
3198764653
Phone
+98 26 3464 3705
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Jamileh Ghalami
Position
Employee
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No.13.West. Ave., Vahdat Town
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3664 8761
Fax
Email
j.ghalami@abzums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Jamileh Ghalami
Position
Employee
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No.13.West, Ave, Vahdat Town
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3664 8761
Fax
Email
j.ghalami@abzums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Jamileh Ghalami
Position
Employee
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No.13.West, Ave,Vahdat Town
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3664 8761
Fax
Email
j.ghalami@abzums.ac.ir
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
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