The survey of oral supplementation effects with probiotic and alpha-lipoic acid, separately or in combination on the maintenance of weigh in overweight individuals under isocaloric weight loss diet
Determination of oral supplementation effects with probiotic and alpha-lipoic acid, separately or in combination on the maintenance of weigh in overweight individuals under isocaloric weight loss diet
Design
In this study, 88 people with over-weight who are eligible to enter the study are selected. Participants are randomly assigned to four intervention and control groups and each participant is assigned a code.
Settings and conduct
The present study is a randomized double blind clinical trial. Overweight people referred to the specialized clinic of Velayat hospital of Qazvin University of Medical Sciences are enrolled in this study. Then, 88 patients were selected and randomly divided into four intervention and control groups. In this study, the patient and researcher will be blinded to drugs and placebo
Participants/Inclusion and exclusion criteria
Willingness to cooperate, people with over weight, age range from 18 to 65 years, no acute or chronic metabolic disease, non pregnancy and breastfeeding
Intervention groups
First intervention group: the group receiving the iso-caloric diet with probiotic capsule, 500 mg per day; Second intervention group: the group receiving the iso-caloric diet with the lipoic acid capsule, 600 mg per day + probiotic capsule, 500 mg per day; Third intervention group: the group receiving the iso-calorie diet plus Lipoic acid capsule, 600 mg per day; Control group: the group receiving an iso-caloric diet plus a placebo capsule.
Main outcome variables
Weight, blood pressure, appetite, body fat
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141025019669N10
Registration date:2018-12-16, 1397/09/25
Registration timing:registered_while_recruiting
Last update:2018-12-16, 1397/09/25
Update count:1
Registration date
2018-12-16, 1397/09/25
Registrant information
Name
Hossein Khadem Haghighian
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3375 2135
Email address
khadem.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-30, 1397/09/09
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survey of oral supplementation effects with probiotic and alpha-lipoic acid, separately or in combination on the maintenance of weigh in overweight individuals under isocaloric weight loss diet
Public title
Effect of probiotic and alpha-lipoic acid supplements on the maintenance of weigh in overweight individuals
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Overweight people according to WHO classification according to body mass index
Age range from 18 to 65 years
Exclusion criteria:
Having an acute or chronic metabolic disorder
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
It will be done with simple random method using the lottery. For each patient, a number or code is provided, then the numbers will be written on pieces of paper. The pieces of paper are placed in a container and well stirred, and the sample is selected according to the sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients of both sexes will be randomly assigned to four intervention and control groups using a randomized distribution method. Supplements and a placebo placed in similar containers and encoded by someone other than the investigator, thus causing the patient and the investigator to be blinded to medicine and placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University Of Medical Sciences
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2018-11-10, 1397/08/19
Ethics committee reference number
IR.QUMS.REC.1397.183
Health conditions studied
1
Description of health condition studied
Simple obesity NOS
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified
Primary outcomes
1
Description
Weight
Timepoint
Before the intervention and after the intervention
Method of measurement
Weight of the participants with minimal dress and no shoes to the nearest 0.5 kg using a medical weight scale
2
Description
Blood pressure
Timepoint
Before the intervention and after the intervention
Method of measurement
By medical barometer
3
Description
Appetite
Timepoint
Before the intervention and after the intervention
Method of measurement
Scale Analog Visual questionnaire
4
Description
Body fat
Timepoint
Before the intervention and after the intervention
Method of measurement
Using of Deurenberg equation
5
Description
C reactive protein
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: isocaloric diet based on the needs of the person with probiotic capsule, 500 mg per day for two months (Phase I of the study), probiotic capsule, 500 mg per day four months (Phase II study) Probiotic compounds: Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus bulgaricus, Lactobacillus acidophilus, Bifidobacterium breve, Bifidobacterium longum, Streptococcus thermophilus, Manufacturer: zisttakhmir
Category
Treatment - Drugs
2
Description
Intervention group: isocaloric diet based on the needs of the person with lipoic acid capsule 600 mg per day+ probiotic capsule 500 mg per day for two months (Phase I of the study), lipoic acid capsule 600 mg per day with probiotic capsule 500 mg per day for four months (Phase II study) Probiotic compounds: Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus bulgaricus, Lactobacillus acidophilus, Bifidobacterium breve, Bifidobacterium longum, Streptococcus thermophilus, Manufacturer: zisttakhmir
Category
Treatment - Drugs
3
Description
Intervention group: isocaloric diet based on the needs of the person with lipoic acid capsule 600 mg per day for two month (Phase I of the study), lipoic acid capsule 600 mg per day for four months (Phase II study)
Category
Treatment - Drugs
4
Description
Control group: isocaloric diet with placebo capsule for two month (Phase I of the study), placebo capsule for four months (Phase II study)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Khadem Haghighian
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Khadem Haghighian
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Khadem Haghighian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Khadem Haghighian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
59811 -34197
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Khadem Haghighian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data on primary and secondary outcomes will be published.
When the data will become available and for how long
After completing the study and analyzing the data
To whom data/document is available
All researchers
Under which criteria data/document could be used
There is no objection to the use of data provided the source of the resource.
From where data/document is obtainable
IRCT site
What processes are involved for a request to access data/document