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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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History
# Registration date Revision Id
6 2024-12-06, 1403/09/16 323596
5 2024-01-04, 1402/10/14 291192
4 2023-08-24, 1402/06/02 276516
3 2023-07-23, 1402/05/01 272713
2 2023-06-11, 1402/03/21 268472
1 2022-07-17, 1401/04/26 233722
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  • General information

    2023-05-22, 1402/03/01
    2023-09-23, 1402/07/01
    2023-12-06, 1402/09/15
    2024-03-05, 1402/12/15

  • Primary outcomes

    #1
    Weight
    IL-6
    وزن
    اینترلوکین-6
    Digital scales
    ELISA
    ترازو ديجيتال
    الایزا
    #2
    Body mass index
    TNF-α
    نمايه توده بدنی
    تومور نکروزینگ فاکتور-آلفا
    Kg/m2
    ELISA
    وزن بدن بر حسب کيلوگرم تقسيم بر مجذور قد بر حسب متر
    الایزا
    #3
    Waist circumference
    hs-CRP
    محیط دور کمر
    پروتئین واکنشگر C
    tape
    Enzymatic
    متر
    آنزیمی
    #4
    low-density lipoprotein (LDL-C)
    Gene expression of PPAR-γ
    لیپوپروتئین با چگالی پایین
    بیان ژن PPAR-γ
    Based on Friedwald's formula
    Real time RT-PCR
    براساس فرمول فریدوالد
    Real time RT-PCR
    #5
    Total cholesterol (TC)
    Gene expression of LDL-R
    کلسترول تام سرم
    بیان ژن LDL-R
    Enzymatic
    Real time RT-PCR
    آنزیمی
    Real time RT-PCR
    #6
    IL-6
    Gene expression of NF-κB
    اینترلوکین-6
    بیان ژن NF-κB
    ELISA
    Real time RT-PCR
    الایزا
    Real time RT-PCR
    #7
    TNF-α
    empty
    تومور نکروزینگ فاکتور-آلفا
    empty
    Baseline and after 12 weeks of intervention
    empty
    در ابتدا و بعد از 12 هفته مداخله
    empty
    ELISA
    empty
    الایزا
    empty
    #8
    hs-CRP
    empty
    پروتئین واکنشگر C
    empty
    Baseline and after 12 weeks of intervention
    empty
    در ابتدا و بعد از 12 هفته مداخله
    empty
    Enzymatic
    empty
    آنزیمی
    empty
    #9
    Gene expression of PPAR-γ
    empty
    بیان ژن PPAR-γ
    empty
    Baseline and after 12 weeks of intervention
    empty
    در ابتدا و بعد از 12 هفته مداخله
    empty
    Real time RT-PCR
    empty
    Real time RT-PCR
    empty
    #10
    Gene expression of LDL-R
    empty
    بیان ژن LDL-R
    empty
    Baseline and after 12 weeks of intervention
    empty
    در ابتدا و بعد از 12 هفته مداخله
    empty
    Real time RT-PCR
    empty
    Real time RT-PCR
    empty
    #11
    Gene expression of NF-κB
    empty
    بیان ژن NF-κB
    empty
    Baseline and after 12 weeks of intervention
    empty
    در ابتدا و بعد از 12 هفته مداخله
    empty
    Real time RT-PCR
    empty
    Real time RT-PCR
    empty
    #12
    Fasting blood sugar
    empty
    قند خون ناشتا
    empty
    Baseline and after 12 weeks of intervention
    empty
    در ابتدا و بعد از 12 هفته مداخله
    empty
    Enzymatic method
    empty
    روش آنزیمی
    empty
    #13
    Triglycerides
    empty
    تری گلیسرید
    empty
    Baseline and after 12 weeks of intervention
    empty
    در ابتدا و بعد از 12 هفته مداخله
    empty
    Enzymatic
    empty
    روش آنزیمی
    empty
    #14
    HDL cholesterol
    empty
    اچ دی ال کلسترول
    empty
    Baseline and after 12 weeks of intervention
    empty
    در ابتدا و بعد از 12 هفته مداخله
    empty
    Enzymatic
    empty
    روش آنزیمی
    empty
    #15
    Blood pressure
    empty
    فشار خون
    empty
    Baseline and after 12 weeks of intervention
    empty
    در ابتدا و بعد از 12 هفته مداخله
    empty
    Mercury monometer
    empty
    فشارسنج جیوه ای
    empty
    #16
    Wrist circumference
    empty
    دور مچ
    empty
    Baseline of intervention
    empty
    ابتدای مطالعه
    empty
    Tape measure
    empty
    متر
    empty

  • Secondary outcomes

    #1
    empty
    Triglycerides
    empty
    تری گلیسرید
    empty
    Baseline and after 12 weeks of intervention
    empty
    در ابتدا و بعد از 12 هفته مداخله
    empty
    Enzymatic method
    empty
    روش آنزیمی
    #2
    empty
    Total cholesterol (TC)
    empty
    کلسترول تام سرم
    empty
    Baseline and after 12 weeks of intervention
    empty
    در ابتدا و بعد از 12 هفته مداخله
    empty
    Enzymatic method
    empty
    روش آنزیمی
    #3
    empty
    high-density lipoprotein cholesterol (HDL-C)
    empty
    لیپوپروتئین با چگالی بالا
    empty
    Baseline and after 12 weeks of intervention
    empty
    در ابتدا و بعد از 12 هفته مداخله
    empty
    Enzymatic method
    empty
    روش آنزیمی
    #4
    empty
    low-density lipoprotein cholesterol (LDL-C)
    empty
    لیپوپروتئین با چگالی پایین
    empty
    Baseline and after 12 weeks of intervention
    empty
    در ابتدا و بعد از 12 هفته مداخله
    empty
    Based on Friedwald's formula
    empty
    براساس فرمول فریدوالد
    #5
    empty
    Fasting blood sugar
    empty
    قند خون ناشتا
    empty
    Baseline and after 12 weeks of intervention
    empty
    در ابتدا و بعد از 12 هفته مداخله
    empty
    Enzymatic method
    empty
    روش آنزیمی
    #6
    empty
    Blood pressure
    empty
    فشار خون
    empty
    Baseline and after 12 weeks of intervention
    empty
    در ابتدا و بعد از 12 هفته مداخله
    empty
    Mercury monometer
    empty
    فشارسنج جیوه ای
    #7
    empty
    Body mass index
    empty
    نمایه توده بدنی
    empty
    Baseline and after 12 weeks of intervention
    empty
    در ابتدا و بعد از 12 هفته مداخله
    empty
    Kg/m2
    empty
    وزن بدن بر حسب کيلوگرم تقسيم بر مجذور قد بر حسب متر
    #8
    empty
    Waist circumference
    empty
    محیط دور کمر
    empty
    Baseline and after 12 weeks of intervention
    empty
    در ابتدا و بعد از 12 هفته مداخله
    empty
    Tape
    empty
    متر

Protocol summary

Study aim
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
Design
Randomized, double-blind, placebo-controlled clinical trial
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Serum Inflammatory Biomarkers and the Expression of NF-κB and Lipid Metabolism Related Genes

General information

Reason for update
It was possible to add new parameters due to the proposal of the statistical and executive consultants of the plan.
Acronym
IRCT registration information
IRCT registration number: IRCT20170202032367N6
Registration date: 2022-07-17, 1401/04/26
Registration timing: prospective

Last update: 2024-01-08, 1402/10/18
Update count: 5
Registration date
2022-07-17, 1401/04/26
Registrant information
Name
Hossien Imani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5975
Email address
h-imani@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-03-05, 1402/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of a new developed synbiotic yogurt consumption in adults with metabolic syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
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
Age
From 30 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Room 605, Sixth Floor, Central Building of Tehran University of Medical Sciences, Qods Street, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653911
Approval date
2022-02-08, 1400/11/19
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1275

Health conditions studied

1

Description of health condition studied
Metabolic syndrome
ICD-10 code
Metabolic
ICD-10 code description
E88.81

Primary outcomes

1

Description
IL-6
Timepoint
Baseline and after 12 weeks of intervention
Method of measurement
ELISA

2

Description
TNF-α
Timepoint
Baseline and after 12 weeks of intervention
Method of measurement
ELISA

3

Description
hs-CRP
Timepoint
Baseline and after 12 weeks of intervention
Method of measurement
Enzymatic

4

Description
Gene expression of PPAR-γ
Timepoint
Baseline and after 12 weeks of intervention
Method of measurement
Real time RT-PCR

5

Description
Gene expression of LDL-R
Timepoint
Baseline and after 12 weeks of intervention
Method of measurement
Real time RT-PCR

6

Description
Gene expression of NF-κB
Timepoint
Baseline and after 12 weeks of intervention
Method of measurement
Real time RT-PCR

Secondary outcomes

1

Description
Energy and macronutrients intake
Timepoint
Baseline, 6th week, and at the end of the intervention
Method of measurement
Three day dietary recall questionnaire

2

Description
Physical activity
Timepoint
Baseline, 6th week, and at the end of the intervention
Method of measurement
International Physical Activity Questionnaire

3

Description
Serum level of liver enzymes
Timepoint
Baseline and after 12 weeks of intervention
Method of measurement
Enzymatic

4

Description
Creatinine
Timepoint
Baseline and after 12 weeks of intervention
Method of measurement
Enzymatic

5

Description
Urea
Timepoint
Baseline and after 12 weeks of intervention
Method of measurement
Enzymatic

6

Description
Complete blood cells parameters
Timepoint
Baseline and after 12 weeks of intervention
Method of measurement
Cell counter devices

7

Description
Triglycerides
Timepoint
Baseline and after 12 weeks of intervention
Method of measurement
Enzymatic method

8

Description
Total cholesterol (TC)
Timepoint
Baseline and after 12 weeks of intervention
Method of measurement
Enzymatic method

9

Description
high-density lipoprotein cholesterol (HDL-C)
Timepoint
Baseline and after 12 weeks of intervention
Method of measurement
Enzymatic method

10

Description
low-density lipoprotein cholesterol (LDL-C)
Timepoint
Baseline and after 12 weeks of intervention
Method of measurement
Based on Friedwald's formula

11

Description
Fasting blood sugar
Timepoint
Baseline and after 12 weeks of intervention
Method of measurement
Enzymatic method

12

Description
Blood pressure
Timepoint
Baseline and after 12 weeks of intervention
Method of measurement
Mercury monometer

13

Description
Body mass index
Timepoint
Baseline and after 12 weeks of intervention
Method of measurement
Kg/m2

14

Description
Waist circumference
Timepoint
Baseline and after 12 weeks of intervention
Method of measurement
Tape

Intervention groups

1

Description
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.
Category
Prevention

2

Description
Control group: Will receive 300 g/day of regular yogurt made by Yasuj Pasteurized Milk Company for 12 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Damide Boyer Ahmad Health Center
Full name of responsible person
Mohammad Yazdan-panah
Street address
Boyer Ahmad Health Center, Shahid Dastjerdi alley - Artesh avenue
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591875114
Phone
+98 74 3322 8212
Email
yazdanpanahm@gmail.com

2

Recruitment center
Name of recruitment center
Yasuj Shahid Beheshti Hospital
Full name of responsible person
Zaker Saeedinejad
Street address
Shahid Beheshti hospital, Mohammad Montazeri avenue
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 4721
Email
beheshtihospital@yasooj.ir

3

Recruitment center
Name of recruitment center
Imam Sajjad hospital, Yasuj
Full name of responsible person
Parastou Rad
Street address
Imam Sajjad Hospital, next to Azadi Hotel
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3322 0163
Email
parastou.rad@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Central Building of Tehran University of Medical Sciences, Qods Street, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
afotouhi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hossien Imani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 44, Shahid Hojjat Doost Alley, Naderi St, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
+9821889900285
Email
h_imani@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Imani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 44, Shahid Hojatost Alley, Keshavarz Boulevard, Naderi St
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
+98 21 8899 0285
Email
h-imani@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Jowshan
Position
Student
Latest degree
Master
Other areas of specialty/work
Clinical Nutrition
Street address
No. 13 , Raja 10 Alley , Rajaei street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591956157
Phone
+98 74 3323 2203
Email
mr-jowshan@razi.tums.ac.ir
Web page address
http://joushan.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to confidentiality of participant information, it is not possible to publish it
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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