1. Home
  2. Approved trials
  3. » فارسی

Assessment of gluten free diet effect on anthropometric measurements, metabolic syndrome’s determinants, insulin resistance, inflammatory factors , gut flora in patients with metabolic syndrome

Protocol summary

Study aim
Assessment of gluten free diet effect on anthropometric measurements, metabolic syndrome’s determinants, insulin resistance, inflammatory factors , gut flora in patients with metabolic syndrome
Design
In this randomized clinical trial, 46 subjects diagnosed with metabolic syndrome according to the Adult Treatment Panel III (ATP III) criteria were recruited and a code was allocated to each one of them. Patients were randomly divided into two control and intervention groups.
Settings and conduct
We selected eligible patients based on inclusion criteria from Nutrition and diet therapy clinic, Shahid Beheshti University of Medical Sciences and randomly assigned them into two intervention (n = 23) or control group (n = 23)
Participants/Inclusion and exclusion criteria
Inclusion criteria: having at least three of the dimensions of metabolic syndrome, including weight circumference≥95cm for both genders, high blood pressure (systolic blood pressure≥130mmHg and diastolic blood pressure≥85mmHg) and high triglyceride (>150 mg/dL) Age range 25-65 years BMI ≥25kg/m2 Exclusion criteria: using fat burning and weight loss drugs, multivitamin/mineral, omega-3 and green tea supplements in the past month using insulin or drugs (Metformin or Glibenclamide) for controlling blood sugar having thyroid gland disorders Pregnancy and Lactation ,athletics
Intervention groups
The intervention group received the GFD diet and the control group were informed to continue their regular diet for eight weeks. In the GFD diet, patients were assumed to receive less than 2-gram gluten per day. Through the intervention process, individuals received gluten free breads. Additionally, participants were informed to not use other cereals containing gluten such as cakes, biscuits and etc
Main outcome variables
Fasting blood glucose Triglyceride Cholesterol High Density Lipoprotein (HDL) Low Density Lipoprotein(LDL) Insulin Homeostasis model assessment for insulin resistance (HOMA-IR) Body weight Waist circumstance Systolic and Diastolic pressure Intestinal microbiom C Reactive Protein(CRP) Tumor necrosis factor alpha(TNF-α) Interleukin 6(IL-6)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170723035244N1
Registration date: 2018-01-07, 1396/10/17
Registration timing: retrospective

Last update: 2018-01-07, 1396/10/17
Update count: 0
Registration date
2018-01-07, 1396/10/17
Registrant information
Name
mehdi ehteshami
Name of organization / entity
National Nutrition and Food Sciences Technology Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 22360661
Email address
mehdi.ehteshami@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
National Nutrition and Food Sciences Technology Research Institute
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
2016-08-22, 1395/06/01
Actual recruitment end date
2017-02-19, 1395/12/01
Trial completion date
empty
Scientific title
Assessment of gluten free diet effect on anthropometric measurements, metabolic syndrome’s determinants, insulin resistance, inflammatory factors , gut flora in patients with metabolic syndrome
Public title
The effects of gluten free diet on patients with metabolic syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
having at least three of the dimensions of metabolic syndrome, including weight circumference≥95cm for both genders, high blood pressure (systolic blood pressure≥130mmHg and diastolic blood pressure≥85mmHg) and high triglyceride (>150 mg/dL) Age range 25-65 years BMI ≥25kg/m2
Exclusion criteria:
using fat burning and weight loss drugs, multivitamin/mineral, omega-3 and green tea supplements in the past month using insulin or drugs (Metformin or Glibenclamide) for controlling blood sugar having thyroid gland disorders Pregnancy and Lactation ,athletics
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 46
Actual sample size reached: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals were randomly allocated to one of two study groups with the help of a random number table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Nutrition and Food Sciences Technology Research Institute
Street address
Faculty of Nutrition and Food Sciences, No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
19395-4741
Approval date
2016-07-22, 1395/05/01
Ethics committee reference number
IR.SBMU.nnftri.Rec.1395.61

Health conditions studied

1

Description of health condition studied
metabolic syndrome
ICD-10 code
E78, E66,
ICD-10 code description
mellitusHypertensive heart disease Disorders of lipoprotein metabolism and other lipidaemias, Obesity, Other specified diabetes

Primary outcomes

1

Description
fasting glucose
Timepoint
beginning of trial/ end of trial (2 months later)
Method of measurement
enzymatic method

2

Description
Triglycerid
Timepoint
beginning of trial/ end of trial (2 months later)
Method of measurement
enzymatic method

3

Description
body weight
Timepoint
beginning of trial/ end of trial (2 months later)
Method of measurement
scale

4

Description
waist circumstance
Timepoint
beginning of trial/ end of trial (2 months later)
Method of measurement
meter

5

Description
systolic and diastolic pressure
Timepoint
beginning of trial/ end of trial (2 months later)
Method of measurement
barometer

6

Description
hs-CRP
Timepoint
beginning of trial/ end of trial (2 months later)
Method of measurement
ELISA

7

Description
HDL
Timepoint
beginning of trial/ end of trial (2 months later)
Method of measurement
enzymatic method

8

Description
cholestrol
Timepoint
beginning of trial/ end of trial (2 months later)
Method of measurement
enzymatic method

9

Description
TNF-
Timepoint
beginning of trial/ end of trial (2 months later)
Method of measurement
ELISA

10

Description
serum insulin
Timepoint
beginning of trial/ end of trial (2 months later)
Method of measurement
ELISA

11

Description
intestinal microflora
Timepoint
beginning of trial/ end of trial (2 months later)
Method of measurement
Real-time PCR

Secondary outcomes

1

Description
dietary intake of macronutrient
Timepoint
beginning of trial/ end of trial (2 months later)
Method of measurement
food recall questionnaire

2

Description
dietary intake of energy
Timepoint
beginning of trial/ end of trial (2 months later)
Method of measurement
food recall questionnaire

3

Description
LDL
Timepoint
beginning of trial/ end of trial (2 months later)
Method of measurement
Friedwald

Intervention groups

1

Description
In the GFD group, patients were assumed to receive less than 2-gram gluten per day for eight weeks. Through the intervention process,individuals received gluten free breads. Additionally, participants were informed to not use other cerealscontaining glute
Category
Other

2

Description
control group, were informed to continue their regular diet for eight weeks. . A recommendation sheet containing information regarding controlling overweight and obesity was provided to participants
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Nutrition and diet therapy clinic.
Full name of responsible person
Azita Hekmatdoost
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
19395-4741
Phone
+98 21 2236 0658
Email
A-hekmat2000@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
National Nutrition and Food Sciences Technology Research Institute
Full name of responsible person
Abodoreza Mohammadi
Street address
Faculty of Nutrition and Food Sciences, No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
19395-4741
Phone
+98 21 2236 0658
Email
ab.mohammadi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Nutrition and Food Sciences Technology Research Institute
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
Faculty of Nutrition and Food Sciences
Full name of responsible person
Azita Hekmatdoost
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, No 7, Hafezi street, Farahzadi blvd, Shahrake Gharb
City
Tehran
Province
Tehran
Postal code
19395-4741
Phone
+98 21 2236 0657
Fax
Email
a_hekmat2000@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of nutrition and Food Sciences
Full name of responsible person
Azita Hekmat-doost
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, No 7, Hafezi street, Farahzadi blvd, Shahrake Gharb.
City
Tehran
Province
Tehran
Postal code
19395-4741
Phone
+98 21 2236 0657
Fax
Email
a_hekmat2000@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Hekmatdoost
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, No 7, Hafezi street, Farahzadi blvd, Shahrake Gharb.
City
Tehran
Province
Tehran
Postal code
19395-4741
Phone
+98 21 2236 0657
Fax
Email
a_hekmat2000@yahoo.com
Web page address

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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
In the final report
When the data will become available and for how long
5 years-2019 to 2024
To whom data/document is available
All academic researchers
Under which criteria data/document could be used
all users should cite the resours of data
From where data/document is obtainable
Azita Hekmatdoost,MD,PhD,RD Associate Prof. Dep Clin Nutrition & Dietetics, NNFTRI, SBMU, Tehran, Iran Email:a_hekmat2000@yahoo.com
What processes are involved for a request to access data/document
by E mail
Comments
Loading...