The objective of this randomized controlled clinical trial is to investigate the effect of prebiotic and metformin on the gut microbiota in obese women.
Design
This randomized trial is conducted with parallel group design.
Settings and conduct
Samples of this study will be recruited from obesity clinic in Shariati Hospital in Tehran and participants will be assigned in three groups randomly. In this double-blind trial, participants and investigators are blinded and the packages of drugs are identical.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women aged 20 to 45 years; BMI in the range of 30-40 kg/m2; Exclusion criteria: Pregnancy and lactation; Smoking; Chronic cardiovascular disease, Kidney disorders, liver disorders, inflammatory bowel diseas, diabetes, cancer and history of digestive tract surgery; The incidence of acute gastrointestinal disorder.
Intervention groups
Patients will be randomly assigned to receive metformin or prebiotic or placebo twice per day along with the hypo-caloric diet for two months.
Main outcome variables
Anthropometric measurements, gut microbiome analysis and measurement of faecal short-chain fatty acid concentrations and serum biochemical variables will be done before and after treatment and will be compared among three groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090420001825N2
Registration date:2018-03-17, 1396/12/26
Registration timing:prospective
Last update:2018-03-17, 1396/12/26
Update count:0
Registration date
2018-03-17, 1396/12/26
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
2018-04-04, 1397/01/15
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of metformin and prebiotic on weight and gut microbiota composition in obese women
Public title
The effect of metformin and prebiotic on gut microbiota composition in obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 20 to 45 years;
BMI in the range of 30-40 kg/m2;
Interest in participating in the study
Exclusion criteria:
Pregnancy and lactation;
Smoking;
Chronic cardiovascular disease (history of CHF and using digoxin and warfarin drugs), kidney disorders, liver disorders, inflammatory bowel disease, diabetes, cancer and history of digestive tract surgery;
A history of acute and chronic diarrhea over a month before the start of the study;
The incidence of acute gastrointestinal disorder;
Antibiotic therapy within the two months prior to or during the study;
Multivitamin supplementation during the study;
Routine use of probiotics and prebiotics products over a month before the start of the study;
Routine use of anti-inflammatory drugs within a month prior to the start of the study;
Taking weight loss drugs over the past 3 months;
History of specific weight loss diet over the past 3 months;
History of mental illness
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization: Block randomization
Unit of randomization: individual
The random sequence was built by computer software and allocation concealment was carried out using sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, investigators and healthcare providers are blinded in this study. Supplements and placebo are packaged identically and they are separated by code.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical science
Street address
Jalale Ale Ahmad Ave.
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2016-03-02, 1394/12/12
Ethics committee reference number
IR.TUMS.EMRI.REC.1395.0090
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
Gut microbiota
Timepoint
baseline, endpoint
Method of measurement
Real time PCR, 16S rRNA sequencing
2
Description
weight
Timepoint
baseline, endpoint
Method of measurement
Digital scale
3
Description
Body mass index
Timepoint
baseline, endpoint
Method of measurement
Formula
4
Description
waist and hip circumferences
Timepoint
baseline, endpoint
Method of measurement
Tape
5
Description
Fecal short-chain fatty acids concentrations
Timepoint
baseline, endpoint
Method of measurement
gas chromatography
Secondary outcomes
1
Description
Glucose
Timepoint
baseline, endpoint
Method of measurement
autoanalyzer
2
Description
Insulin
Timepoint
baseline, endpoint
Method of measurement
ELISA
3
Description
Total cholesterol
Timepoint
baseline, endpoint
Method of measurement
spectrophotometric method
4
Description
triglycerides
Timepoint
baseline, endpoint
Method of measurement
spectrophotometric method
5
Description
LDL cholesterol
Timepoint
baseline, endpoint
Method of measurement
spectrophotometric method
6
Description
HDL cholesterol
Timepoint
baseline, endpoint
Method of measurement
spectrophotometric method
7
Description
Liver enzymes
Timepoint
baseline, endpoint
Method of measurement
colorimetric tests
8
Description
hsCRP
Timepoint
baseline, endpoint
Method of measurement
ELISA
9
Description
lipoprotein lipase
Timepoint
baseline, endpoint
Method of measurement
ELISA
10
Description
fasting induced adipose factor
Timepoint
baseline, endpoint
Method of measurement
ELISA
11
Description
GLP1
Timepoint
baseline, endpoint
Method of measurement
ELISA
Intervention groups
1
Description
Intervention group 1: herbal capsule manufactured by Dineh pharmaceutical company, Twice a day with hypocaloric diet (500 kcal less than patients' energy requirements ), for 2 months
Category
Treatment - Drugs
2
Description
Intervention group 2: Metformin 500 mg manufactured by Glyonce, twice a day with hypocaloric diet (500 kcal less than patients' energy requirements ), for 2 months
Category
Treatment - Drugs
3
Description
Control group: Placebo, twice a day with hypocaloric diet (500 kcal less than patients' energy requirements ), for 2 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Shirin Hasani-Ranjbar
Street address
Endocrinology and Metabolism Research Institute, 5th Floor, Shariati Hospital, North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1411413137
Phone
+98 21 8822 0076
Email
sh_hasani@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Institute for Medical Research Development (NIMAD)
Full name of responsible person
Noncommunicable Disease Committee
Street address
No 21, Besat Ave., West Fatemi Ave.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Phone
+98 21 6693 8037
Email
NIMAD@RESEARCH.AC.IR
Grant name
Grant code / Reference number
942022
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development (NIMAD)
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ahmad-Reza Soroush
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Surgery
Street address
Endocrinology and Metabolism Research Institute, 5th Floor, Shariati Hospital, North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1411413137
Phone
+98 21 8822 0076
Email
Soroush1344@gmail.com
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
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinology
Street address
Endocrinology and Metabolism Research Institute, 5th Floor, Shariati Hospital, North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1411413137
Phone
+98 21 8822 0076
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
هانیه السادات اجتهد
Position
PhD by research candidate
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Endocrinology and Metabolism Research Institute, 5th Floor, Shariati Hospital, North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1411413137
Phone
+98 21 8822 0076
Email
haniejtahed@yahoo.com
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
There is no further 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