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The effect of synbiotic supplementation on glycemic indices, inflammatory biomarkers, and appetite in patients with metabolic syndrome, an approach to prevent cardiovascular disease

Protocol summary

Study aim
Determination of the effect of synbiotic supplementation on glycemic indices, inflammatory biomarkers (hs-CRP, TNFα) and appetite in patients with metabolic syndrome
Design
A randomized, placebo-controlled, double-blind parallel-group clinical trial. Fourty eight participants will be randomly allocated to two groups, one group receives synbiotic (n = 24) and another group receives placebo (n = 24).
Settings and conduct
individuals with metabolic syndrome will be recruited from Isfahan Endocrine & Metabolism Research Center (IEMRC), Isfahan, Iran.The synbiotic supplements and placebos will be packed in similar boxes, and the researcher and the patients will not be aware of the content of the pack until the end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness to participate ; age of 20 to 55 years BMI > 25 kg/m2 waist circumference ≥88 cm in women and waist circumference ≥102 cm in men, serum triglyceride ≥150 mg/dl , serum HDL cholesterol <40 mg/dl in men and <50 mg/dl in women, fasting blood glucose ≥100 mg/dl Exclusion critaria :participating in weight loss or weight gain programs ; history of mental disease,cancer,cardiovascular disease. Thyroid, pulmonary,renal and hepatic problems,eating disorders Pregnant,lactating and post menopausal women; Taking any dietary supplements,probiotic , prebiotic and synbiotic food products, antibiotics, drugs that affect appetite and body weight, and anti-inflammatory drugs ; History of allergies to probiotics , prebiotics and maltodextrin products
Intervention groups
Individuals will be divided into two groups to receive two 500 mg synbiotic capsules or two 500 mg placebo capsules per day for 8 weeks.
Main outcome variables
Fasting blood sugar, fasting insulin,HOMA-IR, quantitative insulin sensitivity check index, High Sensitivity C-Reactive Protein, Tumor necrosis factor-α and appetite

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140208016529N4
Registration date: 2020-02-01, 1398/11/12
Registration timing: registered_while_recruiting

Last update: 2020-02-01, 1398/11/12
Update count: 0
Registration date
2020-02-01, 1398/11/12
Registrant information
Name
Mohammad hassan Entezari
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 8487
Email address
entezari@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-14, 1398/09/23
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of synbiotic supplementation on glycemic indices, inflammatory biomarkers, and appetite in patients with metabolic syndrome, an approach to prevent cardiovascular disease
Public title
The effect of synbiotic supplementation on patients with metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Willingness to participate in projects Women and men aged 20-55 years Waist circumference ≥88 cm in women and waist circumference ≥102 cm in men, serum triglyceride ≥150 mg/dl, serum HDL cholesterol <40 mg/dl in men and <50 mg/dl in women, fasting blood glucose ≥100 mg/dl body mass index > 25 kg/m2
Exclusion criteria:
History of mental disease, cancer, cardiovascular disease, thyroid, pulmonary,renal and hepatic problems and eating disorders Pregnant,lactating and post-menopausal women Participating in weight loss or weight gain programs three months before the intervention Taking any dietary supplements, probiotics, prebiotic, synbiotic food products, and antibiotics two months before the intervention Taking drugs that affect appetite and body weight,and anti-inflammatory drugs History of allergies to probiotics , prebiotics and maltodextrin products
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with size 4
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a randomized double-blind clinical trial. Participants and investigators will be blinded to the allocation of synbiotic or placebo.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjrib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-06-26, 1398/04/05
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.182

Health conditions studied

1

Description of health condition studied
Metabolic syndrome
ICD-10 code
E88.9
ICD-10 code description
Metabolic disorder, unspecified

Primary outcomes

1

Description
Fasting Blood Sugar
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Colorimetric method

2

Description
Serum insulin
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
ELISA

3

Description
Homeostasis model assessment of insulin resistance (HOMA-IR)
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Equation

4

Description
Quantitative Insulin Sensitivity Check Index(QUICKI)
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Equation

Secondary outcomes

1

Description
High Sensitivity C-Reactive Protein
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Biochemical method

2

Description
Tumor Necrosis Factor-Alpha (TNF-α)
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
ELISA

3

Description
Appetite
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Visual Analogue Scale

4

Description
Energy content of food
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Food record questionnaire

5

Description
Physical activity energy expenditure
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Metabolic equivalent of tasks questionnaire

Intervention groups

1

Description
Intervention group: Synbiotic Supplement, as 500 mg capsule, twice a day orally, for 8 weeks
Category
Treatment - Drugs

2

Description
Control group: Placebo (as 500 mg capsule, maltodexterin), quite similar to synbiotic capsules, twice a day orally , for 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Endocrin and Metabolism Research Center
Full name of responsible person
Mohammad Hasan Entezari
Street address
Khorram St., Jomhouri Sq.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 1378
Fax
+98 31 3668 1378
Email
entezari@hlth.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University of Medical Sciences, Hezarjrib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Hasan Entezari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezarjrib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 1378
Email
entezari@hlth.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Hasan Entezari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences, Hezarjrib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3171
Email
entezari@hlth.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Hasan Entezari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences, Hezarjrib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3171
Email
entezari@hlth.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The collected deidentified for the primary outcome measure only will be shared.
When the data will become available and for how long
starting 12 months after publication.
To whom data/document is available
Available for people working in academic institutions
Under which criteria data/document could be used
The data will provide for educational use.
From where data/document is obtainable
Dr.Mohammad hasan Entezar ientezari@hlth.mui.ac.ir
What processes are involved for a request to access data/document
The data will send as soon as possible, after receiving the request.
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