Protocol summary

Summary
The objective of this randomized double-blind placebo controlled trial is to assess the effect of probiotic yogurt and regular yogurt consumption on the components, inflammatory and oxidative markers and vascular endothelial function in patients with metabolic syndrome. Subjects will be recruited to the study, according to inclusion criteria: ages between 20 to 65 years; diagnosis of the metabolic syndrome based on definition of the Iranian National Committee of Obesity, and exclusion criteria: suffering from cardiovascular disease, renal failure, diabetes mellitus and gastrointestinal diseases; receiving supplements of probiotic during the two months before the study; pregnancy; lactation; menopause. Subjects including 44 individuals from both sexes will be randomly divided into two intervention and control groups, using a blocked randomization procedure of size of 4. Subjects in intervention and control group will receive 300 g daily of probiotic or regular yogurt respectively for 8 weeks. The assignment of groups will cover from the investigators and the subjects. Probiotic and regular yogurt containers will be identical looking and with three-digit code will be separable. Fasting blood samples, blood pressure and anthropometric measurements, appetite questionnaire, physical activity questionnaire, 3 dietary records for each person will be performed at the beginning and end of the study. The levels of markers of inflammatory and oxidative and vascular endothelial function, blood sugar, lipid profile and insulin in the fasting blood samples will be assessed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201608213140N17
Registration date: 2016-11-09, 1395/08/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-11-09, 1395/08/19
Registrant information
Name
Bahram Pourghassem Gargari
Name of organization / entity
Health and Nutrition Faculty, Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1435 7580
Email address
pourghassemb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of probiotic yogurt and regular yogurt consumption on the components, inflammatory and oxidative markers and vascular endothelial function in patients with metabolic syndrome
Public title
The effect of probiotic yogurt and regular yogurt consumption in patients with metabolic syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to participate; women and men aged 20-65 years; diagnosis of the metabolic syndrome based on the presence of any 3 of the criteria defined by the Iranian National Committee of Obesity: waist circumference ≥95 cm in both genders; fasting serum glucose ≥100 mg/dl; serum triglyceride ≥150 mg/dl; serum HDL cholesterol <40 mg/dl in men and <50 mg/dl in women; systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥85 mmHg. Exclusion criteria: suffering from cardiovascular disease, renal failure, diabetes and gastrointestinal diseases; receiving antibiotics; supplement of vitamin and minerals, fiber, omega-3 and probiotic supplements during the two months before the start of the study; presence of pregnancy or lactation or menopause; extreme sports more than 100 minutes per week; having the weight loss diet the three months before the study; hormone therapy; taking contraceptive drugs; alcohol intake, smoking and tobacco; history of cancer and medical treatment and drugs that affect the neuroendocrine function, metabolism or appetite; thyroid problems; gastrointestinal surgery during the past year; treatment with immunomodulatory drugs one month before the study; chronic use of laxative (more than twice a week).
Age
From 20 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Attar Neyshaboori Street, Golgasht Avenue, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2016-08-29, 1395/06/08
Ethics committee reference number
IR.TBZMED.REC.1395.668

Health conditions studied

1

Description of health condition studied
Metabolic Syndrom
ICD-10 code
ٍE88.9
ICD-10 code description
metabolic disorders not specified

Primary outcomes

1

Description
Blood glucose
Timepoint
Begining and end of the intervention
Method of measurement
Enzymatic

2

Description
Insulin, insulin resistance index
Timepoint
Begining and end of the intervention
Method of measurement
ELISA and HOMA-IR formula

3

Description
Lipid profile
Timepoint
Begining and end of the intervention
Method of measurement
Spectrophotometry

4

Description
Blood pressure
Timepoint
Begining and end of the intervention
Method of measurement
Digital monometer

5

Description
Anthropometry markers
Timepoint
Begining and end of the intervention
Method of measurement
Stadiometer, scale, tape

6

Description
Tumor Necrosis Factor-Alpha (TNF-α)
Timepoint
Begining and end of the intervention
Method of measurement
ELISA

7

Description
Interleukin-6 (IL-6)
Timepoint
Begining and end of the intervention
Method of measurement
ELISA

8

Description
hs-CRP
Timepoint
Begining and end of the intervention
Method of measurement
Immunotorbidometry

9

Description
Lipopolysaccharides (LPS)
Timepoint
Begining and end of the intervention
Method of measurement
ELISA

10

Description
Malondialdehyde (MDA)
Timepoint
Begining and end of the intervention
Method of measurement
Spectrophotometry

11

Description
Total Antioxidant Capacity
Timepoint
Begining and end of the intervention
Method of measurement
Spectrophotometry

12

Description
Uric Acid
Timepoint
Begining and end of the intervention
Method of measurement
Enzymatic

13

Description
Oxidized LDL (OxLDL)
Timepoint
Begining and end of the intervention
Method of measurement
ELISA

14

Description
Plasminogen Activator Inhibitor-1 (PAI-1)
Timepoint
Begining and end of the intervention
Method of measurement
ELISA

15

Description
Vascular Cell Adhesion Molecule Type 1 (VCAM-1)
Timepoint
Begining and end of the intervention
Method of measurement
ELISA

16

Description
Intercellular Adhesion Molecule Type 1 (ICAM-1)
Timepoint
Begining and end of the intervention
Method of measurement
ELISA

Secondary outcomes

1

Description
Appetite
Timepoint
Begining and end of the intervention
Method of measurement
Appetite Questionnaire (Visual Analouge Scale)

2

Description
Physical activity
Timepoint
Begining and end of the intervention
Method of measurement
International Physical Activity Questionnaire

3

Description
Energy and macronutrients intake
Timepoint
Begining and end of the intervention
Method of measurement
Three day dietary record questionnair

Intervention groups

1

Description
Intervention group: 300 g/day probiotic yogurt including Lactobacillus acidophilus La5 and bifidobacterium lactis Bb12 for 8 weeks
Category
Prevention

2

Description
Placebo group: 300 g/day regular yogurt
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sceinces
Full name of responsible person
Dr. Pourgasem Gargari
Street address
Attar Neyshaboori Street, Golgasht Avenue, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Attar Neyshaboori Street, Golgasht Avenue, Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences
Full name of responsible person
Leila Rezazadeh
Position
Ph.D candidate of Nutrition
Other areas of specialty/work
Street address
Attar Neyshaboori Street, Golgasht Avenue, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3335 7581
Fax
Email
rezazadehl@tbzmed.ac.ir; rezazadehleila@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sceinces
Full name of responsible person
Dr. Bahram Pourghasem Gargari
Position
Ph.D of Nutrition
Other areas of specialty/work
Street address
Attar Neyshaboori Street, Golgasht Avenue, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3337 6229
Fax
Email
bahrampg@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences
Full name of responsible person
Leila Rezazadeh
Position
Ph.D candidate of Nutrition
Other areas of specialty/work
Street address
Attar Neyshaboori Street, Golgasht Avenue, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3335 7580
Fax
Email
rezazadehl@tbzmed.ac.ir; rezazadehleila@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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