Protocol summary
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Study aim
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Examining The Effect of a New Developed Synbiotic Yogurt Consumption on Serum Inflammatory Biomarkers and the Expression of NF-κB and Lipid Metabolism Related Genes in Adults with Metabolic Syndrome
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Design
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Randomized, double-blind, placebo-controlled clinical trial
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Settings and conduct
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The intervention will be performed for 12 weeks on people with metabolic syndrome in health centers in Yasuj. People will be given 14 cans of yogurt once every two weeks, and patients will consume a 300-gram can of yogurt daily.The evaluation of variables is done at the beginning and end of the study by sampling the patient's blood.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age between 30 and 50 years old, body mass index= 25-35 Kg/m2, the presence of at least three of the five components of the metabolic syndrome, and willingness to participate in the study. Exclusion criteria: weight changes of more than 10% in the last six months, change in the amount of sports activity, pregnant, lactating, and postmenopausal women, allergy to dairy products and probiotics, smoking and alcohol consumption, routine consumption of probiotic or synbiotic products, suffering from various diseases, taking certain medications such as antibiotics, anti-diabetics, and lipid-lowering drugs, uncontrolled blood pressure, consuming probiotic supplements.
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Intervention groups
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The subjects in the intervention group will receive 300 g/day of synbiotic yogurt containing Lactobacillus Plantarum, Lactobacillus pentosus (2˟108 CFU), and the yeast Kluyveromyces marxianus and 3% of natural plants (mountain celery, shallot, chicory, and mint) for 12 weeks. The control group will consume 300 g/day of regular yogurt. Yasuj Pasteurized Milk Company will provide the yogurts.
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Main outcome variables
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Serum Inflammatory Biomarkers and the Expression of NF-κB and Lipid Metabolism Related Genes
General information
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Reason for update
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It was possible to add new parameters due to the proposal of the statistical and executive consultants of the plan.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170202032367N6
Registration date:
2022-07-17, 1401/04/26
Registration timing:
prospective
Last update:
2024-12-11, 1403/09/21
Update count:
5
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Registration date
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2022-07-17, 1401/04/26
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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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2022-07-23, 1401/05/01
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Expected recruitment end date
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2022-11-22, 1401/09/01
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Actual recruitment start date
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2022-07-23, 1401/05/01
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Actual recruitment end date
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2022-12-06, 1401/09/15
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Trial completion date
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2023-04-04, 1402/01/15
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Scientific title
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Effects of Daily Low-Fat Synbiotic Yogurt Consumption on Metabolic Parameters, Inflammatory Biomarkers, and Gene Expression Related to Inflammation and Lipid in Adults with Metabolic Syndrome
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Public title
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The effect of a new developed synbiotic yogurt consumption in adults with metabolic syndrome
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age between 30 and 50 years old
Body mass index (BMI) ranged from 25 to 35 kg/m2
The presence of at least three of the five components of the metabolic syndrome according to the ATP III criteria including waist circumference greater than 102 cm in men and 88 cm in women, triglyceride equal to or greater than 150 mg/dL, HDL less than or equal to 40 in men and less than or equal to 50 In women, blood pressure equal to or greater than 130/85 mmHg and blood sugar equal to or greater than 100 mg/dL
Willingness to participate in the study
Exclusion criteria:
Participate in weight loss programs over the past six months
Weight change of more than 10% in the last six months
Professional athletes or changes in the intensity and level of physical activity during the last four weeks
Pregnant, lactating and postmenopausal women
Allergy to dairy products and probiotics
Smoking and alcohol consumption
Routine consumption of products containing probiotics or synbiotics
Diagnosed cardiovascular, kidney, gastrointestinal, endocrine, pulmonary, neurological, and autoimmune diseases; diabetes; thyroid dysfunction; cancer; and eating disorders.
Taking medications that could affect appetite, body weight, and lipid metabolism or have anti-inflammatory effects such as corticosteroids, oral contraceptives, antidepressants and antipsychotics, anti-diabetics, statins, and other lipid-lowering drugs.
Take antibiotics one month before the study begins
Uncontrolled blood pressure
ke probiotics and other dietary supplements within one months before the start of the study
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Age
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From 30 years old to 50 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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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
44
Actual sample size reached:
41
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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First, we will use the Stratified Permuted Block Randomization method for patients who meet the inclusion criteria for random distribution in the intervention and control groups. First, they are classified in terms of gender (male/female) and body mass index level (from 25–29.9 and 35–30) and are placed in double blocks using the randomization method with sizes 2 and 4 (from the special table). used for randomization). Accordingly, each person may have four states. Then, people with the same conditions are randomly divided into intervention and control groups. In order to randomly assign both people to one of the groups, each person will be given a code, and these codes will be poured into a pot. An out-of-study person will then be asked to draw the codes out of the pot using a lottery. The person with the first code issued will be assigned to the intervention group and the other person to the control group. This process will be done in the same way for both people with the same condition.
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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 enrolled in this study will be unaware of whether they are in the normal yogurt group or in the synbiotic yogurt group. On the other hand, due to the similarity of the appearance of both products, which are given to the participants in packages with the same appearance and the same label, an attempt has been made to blind the patients. Also other people who participate in other stages including the researchers , the outcome evaluators, the analysts are blind to the study, and the third independent person is responsible for prescribing and secretly recording our type of prescription, and the other person is responsible for collecting data. The data analyzer also announces the results according to groups A and B. The drug evaluator also does not know the type of yogurt prescribed for each patient.
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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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2022-02-08, 1400/11/19
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1400.1275
Health conditions studied
1
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Description of health condition studied
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Metabolic syndrome
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ICD-10 code
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Metabolic
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ICD-10 code description
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E88.81
Primary outcomes
1
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Description
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IL-6
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Timepoint
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Baseline and after 12 weeks of intervention
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Method of measurement
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ELISA
2
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Description
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TNF-α
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Timepoint
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Baseline and after 12 weeks of intervention
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Method of measurement
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ELISA
3
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Description
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hs-CRP
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Timepoint
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Baseline and after 12 weeks of intervention
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Method of measurement
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Enzymatic
4
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Description
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Gene expression of PPAR-γ
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Timepoint
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Baseline and after 12 weeks of intervention
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Method of measurement
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Real time RT-PCR
5
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Description
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Gene expression of LDL-R
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Timepoint
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Baseline and after 12 weeks of intervention
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Method of measurement
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Real time RT-PCR
6
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Description
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Gene expression of NF-κB
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Timepoint
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Baseline and after 12 weeks of intervention
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Method of measurement
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Real time RT-PCR
Secondary outcomes
1
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Description
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Energy and macronutrients intake
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Timepoint
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Baseline, 6th week, and at the end of the intervention
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Method of measurement
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Three day dietary recall questionnaire
2
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Description
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Physical activity
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Timepoint
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Baseline, 6th week, and at the end of the intervention
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Method of measurement
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International Physical Activity Questionnaire
3
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Description
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Serum level of liver enzymes
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Timepoint
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Baseline and after 12 weeks of intervention
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Method of measurement
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Enzymatic
4
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Description
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Creatinine
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Timepoint
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Baseline and after 12 weeks of intervention
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Method of measurement
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Enzymatic
5
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Description
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Urea
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Timepoint
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Baseline and after 12 weeks of intervention
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Method of measurement
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Enzymatic
6
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Description
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Complete blood cells parameters
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Timepoint
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Baseline and after 12 weeks of intervention
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Method of measurement
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Cell counter devices
7
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Description
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Triglycerides
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Timepoint
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Baseline and after 12 weeks of intervention
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Method of measurement
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Enzymatic method
8
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Description
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Total cholesterol (TC)
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Timepoint
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Baseline and after 12 weeks of intervention
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Method of measurement
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Enzymatic method
9
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Description
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high-density lipoprotein cholesterol (HDL-C)
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Timepoint
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Baseline and after 12 weeks of intervention
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Method of measurement
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Enzymatic method
10
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Description
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low-density lipoprotein cholesterol (LDL-C)
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Timepoint
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Baseline and after 12 weeks of intervention
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Method of measurement
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Based on Friedwald's formula
11
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Description
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Fasting blood sugar
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Timepoint
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Baseline and after 12 weeks of intervention
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Method of measurement
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Enzymatic method
12
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Description
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Blood pressure
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Timepoint
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Baseline and after 12 weeks of intervention
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Method of measurement
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Mercury monometer
13
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Description
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Body mass index
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Timepoint
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Baseline and after 12 weeks of intervention
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Method of measurement
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Kg/m2
14
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Description
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Waist circumference
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Timepoint
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Baseline and after 12 weeks of intervention
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Method of measurement
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Tape
Intervention groups
1
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Description
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Intervention group: Will receive 300 g/day of synbiotic yogurt containing Lactobacillus Plantarum, Lactobacillus pentosus (2˟108 CFU), and Kluyveromyces marxianus and 3% of various natural plants (mountain celery, shallot, chicory, and mint) made by Yasuj Pasteurized Milk Company for 12 weeks.
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Category
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Prevention
2
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Description
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Control group: Will receive 300 g/day of regular yogurt made by Yasuj Pasteurized Milk Company 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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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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Due to confidentiality of participant information, it is not possible to publish it
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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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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable