Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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Willingness to cooperate, people with over weight, age range from 18 to 65 years, no acute or chronic metabolic disease, non pregnancy and breastfeeding
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Intervention groups
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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.
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Main outcome variables
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Weight, blood pressure, appetite, body fat
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20141025019669N10
Registration date:
2018-12-16, 1397/09/25
Registration timing:
registered_while_recruiting
Last update:
2019-10-20, 1398/07/28
Update count:
1
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Registration date
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2018-12-16, 1397/09/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-11-30, 1397/09/09
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Expected recruitment end date
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2019-02-19, 1397/11/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Effect of probiotic and alpha-lipoic acid supplements on the maintenance of weigh in overweight individuals
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
88
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-11-10, 1397/08/19
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Ethics committee reference number
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IR.QUMS.REC.1397.183
Health conditions studied
1
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Description of health condition studied
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Simple obesity NOS
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ICD-10 code
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E66.9
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ICD-10 code description
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Obesity, unspecified
Primary outcomes
1
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Description
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Weight
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Timepoint
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Before the intervention and after the intervention
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Method of measurement
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Weight of the participants with minimal dress and no shoes to the nearest 0.5 kg using a medical weight scale
2
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Description
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Blood pressure
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Timepoint
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Before the intervention and after the intervention
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Method of measurement
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By medical barometer
3
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Description
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Appetite
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Timepoint
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Before the intervention and after the intervention
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Method of measurement
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Scale Analog Visual questionnaire
4
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Description
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Body fat
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Timepoint
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Before the intervention and after the intervention
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Method of measurement
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Using of Deurenberg equation
5
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Description
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C reactive protein
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Timepoint
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Before the intervention and after the intervention
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Method of measurement
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Eliza
6
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Description
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Sleep quality
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Timepoint
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Before intervention and after intervention
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Method of measurement
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Petersburg’s sleep quality questionnaire
Intervention groups
1
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Description
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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
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Category
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Treatment - Drugs
2
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Description
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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
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Category
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Treatment - Drugs
3
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Description
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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)
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Category
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Treatment - Drugs
4
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Description
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Control group: isocaloric diet with placebo capsule for two month (Phase I of the study), placebo capsule for four months (Phase II study)
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Qazvin University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Data on primary and secondary outcomes will be published.
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When the data will become available and for how long
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After completing the study and analyzing the data
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To whom data/document is available
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All researchers
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Under which criteria data/document could be used
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There is no objection to the use of data provided the source of the resource.
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From where data/document is obtainable
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IRCT site
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What processes are involved for a request to access data/document
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Six months after the study
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Comments
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