Effect of Concomitant Synbiotic and L-Carnitine Supplementation on Nutritional Status, Metabolic, Oxidative, Inflammatory Indices and Plasma Levels of Trimethylamine Oxide (TMAO) in Obese Women
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General information
IRCT20080904001197N12
IRCT20080904001197N13
IRCT20080904001197N12IRCT20080904001197N13
2018-01-19, 1396/10/29
2018-01-19, 1396/10/29
2018-01-19 11:08:4149
Protocol summary
Study aim
Effect of Concomitant Synbiotic and L-Carnitine Supplementation on Nutritional Status, Metabolic, Oxidative and Inflammatory Indices and Plasma Levels of Trimethylamine Oxide (TMAO) in Obese Women
Design
In this double blind randomized clinical trial, 90 obese volunteer eligible women will be recruited by simple sampling method through public announcement and randomly allocated into two intervention groups; informed consent will be obtained from each participant.
Settings and conduct
Allocation to groups will be blinded for the researcher and participants.Study will be conducted at Nutrition Research Center, Tabriz University of Medical Sciences. Sampling will be done through public announcement.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female volunteers, age: 19-49 years & Body Mass Index between 30 to 35 kg/m2. Exclusion criteria: diabetes, cardiovascular, gastrointestinal, thyroid, infectious and ... disorders. Taking any antibiotics, probiotic or synbiotics or following weight loss diets during or 2 months before entering the study; taking steroid, immunosuppressive or anticonvulsant drugs.
Intervention groups
Intervention group 1:1000 mg/day L-carnitine as two 500 mg tablets and one 250 mg synbiotic capsule; Intervention group 2: 1000 mg/day L-carnitine as two 500 mg tablets and synbiotic placebo; for 8 weeks
Main outcome variables
Nutritional status (Dietary intake & Anthropometric indices); Metabolic (Lipid profile, Glucose, Insulin, HOMA-IR); Oxidative (Total Antioxidant Capacity(TAC) & Malondialdehyde(MDA); Inflammatory (hs-CRP, IL-6, TNF-α, LPS); Anti inflammatory (IL-10) Indices and plasma Trimethylamine Oxide (TMAO) levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080904001197N13
Registration date:2018-01-19, 1396/10/29
Registration timing:prospective
Last update:2018-01-19, 1396/10/29
Update count:2
Registration date
2018-01-19, 1396/10/29
Registrant information
Name
Reza Mahdavi
Name of organization / entity
Faculty of Health & Nutrition, Tabriz UniV. of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7584
Email address
mahdavir@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Concomitant Synbiotic and L-Carnitine Supplementation on Nutritional Status, Metabolic, Oxidative, Inflammatory Indices and Plasma Levels of Trimethylamine Oxide (TMAO) in Obese Women
Public title
Effect of Concomitant Synbiotic and L-Carnitine Supplementation in Obese Women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female
Age: 19-49 years
Body Mass Index between 30 to 35 kg/m2
Patient tendency to participate in the study
Exclusion criteria:
Pregnancy
Lactation
Menopause
Cardiovascular diseases, kidney, lung, gastrointestinal, infectious, diabetes or thyroid disorders
History of recent surgeries or any intestine surgeries
Taking any Antibiotics during or 2 months before entering the study
Taking Probiotic, Prebiotic or Synbiotic supplements during or 2 months before entering the study
Taking Fish oil or any weight loss supplements during or 2 months before entering the study
Vegetarians
Smoking or Alcohol Consumption
Following weight loss diets during or 2 months before entering the study
Taking Steroid, Immunosuppressive or Anticonvulsant drugs
Age
From 19 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed by permuted block randomization (block size:4 or 8) using RAS software.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double blind study in which the researcher and patients will be blinded to the group assignments. The patients will receive the supplements by another person who is not involved in performing the assessment and chemical analysis. Patients will be informed of two study groups, however group assignments will be blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Daneshgah st.,Tabriz, University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614776
Approval date
2017-12-04, 1396/09/13
Ethics committee reference number
IR.TBZMED.REC.1396.747
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
Body Mass Index (BMI)
Timepoint
At the beginning, after 4 weeks and at the end of the intervention (after 8 weeks)
Method of measurement
BMI= weight(kg)/height^2(m^2)
2
Description
Dietary intake
Timepoint
At the beginning, after 4 weeks and at the end of the intervention (after 8 weeks)
Method of measurement
24 hours food recall questionnaire
3
Description
Plasma Trimethylamine Oxide (TMAO) level
Timepoint
At the beginning & end of the intervention (8 weeks)
At the beginning & end of the intervention (8 weeks)
Method of measurement
kit/ Spectrophotometry
2
Description
Oxidative factors: Malondialdehide (MDA)
Timepoint
At the beginning & end of the intervention (8 weeks)
Method of measurement
Thio Barbituric Acid (TBA), Fluorimetric method
3
Description
Inflammatory factors: hs-CRP
Timepoint
At the beginning & end of the intervention (8 weeks)
Method of measurement
Immunoturbidimetry method
4
Description
Inflammatory factors: IL-6
Timepoint
At the beginning & end of the intervention (8 weeks)
Method of measurement
Enzyme-linked Immunosorbent Assay (ELISA) kit
5
Description
Inflammatory factors: TNF-α
Timepoint
At the beginning & end of the intervention (8 weeks)
Method of measurement
Enzyme-linked Immunosorbent Assay (ELISA) kit
6
Description
Inflammatory factors: Lipopolysaccharide (LPS)
Timepoint
At the beginning & end of the intervention (8 weeks)
Method of measurement
Enzyme-linked Immunosorbent Assay (ELISA) kit
7
Description
Anti Inflammatory factor: IL-10
Timepoint
At the beginning & end of the intervention (8 weeks)
Method of measurement
Enzyme-linked Immunosorbent Assay (ELISA) kit
8
Description
Insulin resistance indices: Glucose
Timepoint
At the beginning & end of the intervention (8 weeks)
Method of measurement
Spectrophotometry
9
Description
Insulin resistance indices: Insulin
Timepoint
At the beginning & end of the intervention (8 weeks)
Method of measurement
Enzyme-linked Immunosorbent Assay (ELISA)
10
Description
Insulin resistance indices: Homeostatic Model Assessment (HOMA) of Insulin Resistance (HOMA-IR)
Timepoint
At the beginning & end of the intervention (8 weeks)
Method of measurement
Formula calculation
11
Description
Lipid Profile: Triglyceride (TG)
Timepoint
At the beginning & end of the intervention (8 weeks)
Method of measurement
kit/ Spectrophotometry
12
Description
Lipid Profile: Total cholesterol (TC)
Timepoint
At the beginning & end of the intervention (8 weeks)
Method of measurement
kit/ Spectrophotometry
13
Description
Lipid Profile: HDL-c
Timepoint
At the beginning & end of the intervention (8 weeks)
Method of measurement
kit/ Spectrophotometry
14
Description
Lipid Profile: LDL-c
Timepoint
At the beginning & end of the intervention (8 weeks)
Method of measurement
Formula calculation
Intervention groups
1
Description
Intervention group 1: Oral administration of 1000 mg/day L-carnitine as two 500 mg tablets (Karen pharmaceutical and nutritional supplements company) taken with lunch & dinner, and one 250 mg synbiotic capsule, Cfu: 1x108 (Protexin, UK), for 8 weeks
Category
Treatment - Other
2
Description
Intervention group 2: Oral administration of 1000 mg/day L-carnitine as two 500 mg tablets (Karen pharmaceutical and nutritional supplements company) taken with lunch & dinner, and one synbiotic placebo capsule, (maltodextrin), for 8 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Nutrition Research Center, Tabriz University of Medical Sciences / Public Announcement
Full name of responsible person
Prof. Reza Mahdavi
Street address
Golgasht St., Nutrition & Food Sciences Faculty, Nutrition Research Center, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2295
Email
mahdavir@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nutrition Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Prof. Alireza Ostadrahimi
Street address
Golgasht St., Nutrition & Food Sciences Faculty, Nutrition Research Center, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2295
Email
nut-rc@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutrition Research Center, Tabriz 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
Nutrition Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Farnoush Fallah
Position
Ph.D Candidate of Nutrition Sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Nutrition Research Center, Nutrition & Food Sciences Faculty, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2295
Fax
Email
fallahfarnoush@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nutrition Research center, Tabriz University of Medical Sciences
Full name of responsible person
Prof. Reza Mahdavi
Position
Ph.D of Nutrition, Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Research Center, Nutrition & Food Sciences Faculty, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Fax
Email
mahdavir@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nutrition Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Farnoush Fallah
Position
Ph.D Candidate of Nutrition Sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Nutrition Research Center, Nutrition & Food Sciences Faculty, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2295
Email
fallahfarnoush@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Study Protocol, Statistical Analysis Plan, Informed Consent Form & Clinical Study Report will be shared.
When the data will become available and for how long