Protocol summary
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Study aim
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The aim of this study is to prepare and produce effective probiotic formulations in obese adults and to evaluate their effectiveness on anthropometric indices, lipid profile, glycemic control, liver enzymes, inflammatory factors and GLP1 hormone.
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Design
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Double-blind Randomized clinical trial (both patients and researchers) with a parallel group design.
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Settings and conduct
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From outpatients with obesity referred to the nutrition clinic of Shariati Hospital affiliated to Tehran University of Medical Sciences, 60 patients will be selected based on inclusion and exclusion criteria. Participants and researchers are unaware of the allocation of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken from patients at the beginning of the study and 12 weeks after the intervention.
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Participants/Inclusion and exclusion criteria
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This randomized clinical trial will be performed on 60 eligible obese adults. Subjects are randomly divided into one of two groups: supplements and placebo. The duration of the intervention is 3 months, and people take supplements or placebos in addition to a low-calorie weight loss diet. At the beginning and end of the study, people have blood and stool tests and are examined for anthropometric indicators and food intake (24-hour recall questionnaire).
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Intervention groups
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Intervention group: Probiotic supplement capsule made by Tak Gene Pharmaceutical Company, twice a day with low calorie diet (500 kcal less than the person energy need), for three months
Control group: Placebo, twice daily with low calorie diet (500 kcal less than the person energy need), for three months
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Main outcome variables
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Weight
Body Mass Index
Waist circumference and hip circumference
Intestinal microbiota
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:
IRCT20090420001825N3
Registration date:
2020-09-07, 1399/06/17
Registration timing:
prospective
Last update:
2021-04-08, 1400/01/19
Update count:
1
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Registration date
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2020-09-07, 1399/06/17
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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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2020-10-06, 1399/07/15
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Expected recruitment end date
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2021-03-21, 1400/01/01
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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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Effectiveness assessment of a probiotic supplement on weight control in obese adults: a double blind clinical trial
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Public title
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The effect of probiotic supplement on weight in obese people
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age range: 20 to 55 years
Body mass index: 30 to 40 kg/m2
Interest in participating in the project
Exclusion criteria:
unwillingness to cooperate
pregnancy and lactation
smoking
cardiovascular disease (history of myocardial infarction and use of digoxin and warfarin)
renal disease (creatinine above 2 mg/dL and GFR less than 30 )
Liver disease (liver enzyme levels two and a half times normal)
inflammatory bowel disease such as colitis
diabetes
cancer
history of gastrointestinal surgery
use of antibiotics during the two months before the start of the study and during the study
taking multivitamin supplements during the study
common use of probiotics and prebiotics during the month before the start of the study
common use Anti-inflammatory drugs during the month before the start of the study
use of weight loss drugs in the last 3 months
history of special diet for weight loss in the last 3 months
history of mental illness
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Age
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From 20 years old to 55 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization is performed in order to balance the number of samples assigned to each of the study groups. Web randomization (https://www.sealedenvelope.com) is used for this purpose. The number and characteristics of the participants are entered in the desired position and the individuals are randomly assigned to one of the two intervention and placebo groups.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study, participants, researchers, and clinical caregivers were unaware that each participant in the study was in the main intervention group (receiving a probiotic supplement) or a placebo (without a probiotic). Supplements and placebos are packaged exactly the same and separated by code. Therefore, people cannot identify which group they belong to.
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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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2019-03-07, 1397/12/16
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Ethics committee reference number
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IR.TUMS.EMRI.REC.1398.001
Health conditions studied
1
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Description of health condition studied
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obesity
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ICD-10 code
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E66
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ICD-10 code description
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Overweight and obesity
Primary outcomes
1
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Description
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weight
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Timepoint
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Beginning and end of the intervention
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Method of measurement
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Digital scale
2
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Description
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Body mass index
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Timepoint
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Beginning and end of the intervention
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Method of measurement
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Formula
3
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Description
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Waist circumference and hip circumference
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Timepoint
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Beginning and end of the intervention
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Method of measurement
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Tape meter
Secondary outcomes
1
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Description
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Waist to hip ratio
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Timepoint
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Beginning and end of the intervention
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Method of measurement
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Formula
2
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Description
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fasting glucose blood
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Timepoint
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Beginning and end of the intervention
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Method of measurement
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Autoanalyzer
3
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Description
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insulin
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Timepoint
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Beginning and end of the intervention
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Method of measurement
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Eliza
4
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Description
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Total cholesterol
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Timepoint
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Beginning and end of the intervention
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Method of measurement
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Spectrophotometry
5
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Description
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HDL
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Timepoint
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Beginning and end of the intervention
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Method of measurement
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Spectrophotometry
6
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Description
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LDL
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Timepoint
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Beginning and end of the intervention
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Method of measurement
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Spectrophotometry
7
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Description
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TG
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Timepoint
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Beginning and end of the intervention
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Method of measurement
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Spectrophotometry
8
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Description
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Liver enzymes (ALT and AST)
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Timepoint
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Beginning and end of the intervention
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Method of measurement
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Colorimetric test
9
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Description
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hsCRP
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Timepoint
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Beginning and end of the intervention
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Method of measurement
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Eliza
10
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Description
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GLP1
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Timepoint
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Beginning and end of the intervention
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Method of measurement
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Eliza
11
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Description
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Intestinal microbiota
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Timepoint
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Beginning and end of the intervention
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Method of measurement
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Real-time polymerase chain reaction
Intervention groups
1
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Description
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Intervention group: Receive a weight loss diet and probiotic supplement for 12 weeks, A weight loss diet (500 kcal less than the daily requirement and the composition of the prescribed diet was 55% carbohydrate, 30% fat and 15%protein) is prescribed for the patient and a probiotic supplement manufactured by the TAKGENE pharmaceutical company (Contains Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus casei, Bifidobacterium langum, 10 to 8 or 9 cfu per capsule) twice per day is prescribed for 12 weeks.
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Category
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Treatment - Other
2
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Description
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Control group: Receive weight loss diet and placebo for 12 weeks, The usual weight loss diet (500 kcal less than the daily requirement and the composition of the prescribed diet was 55% carbohydrate, 30% fat and 15%protein) is prescribed for the patient and the placebo (containing maltodextrine and magnesium stearate) is prescribed in the same size and shape as supplements made by TAKGENE Pharmaceutical Company, twice per day for 12 weeks.
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Category
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Placebo
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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Endocrinology and Metabolism Research Institute, Tehran 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable