Protocol summary

Summary
Objectives: Patients with metabolic syndrome will be assessed to determine the effects of low carbohydrate diets on serum concentrations of inflammatory and metabolic factors, weight and body composition. Design: A randomized controlled trial with factorial design. Setting and conduct: 80 Subjects will be randomly divided into four groups. For each patient anthropometric measurement, general characteristics will be assessed and 15 cc fasting blood samples will be taken from each patient at the baseline and end of study. 24-h food record questionnaire and physical activity questionnaire will be completed every four week. Inclusion criteria: Age: 20-50 years old; meeting the NCEP-ATPIII criteria (Three or more of the following five criteria should be met: Waist circumference over 40 inches (men) or 35 inches (women); Blood pressure over 130/85 mmHg; Fasting triglyceride over 150 mg/dl; Fasting HDL-cholesterol less than 40 mg/dl (men) or 50 mg/dl (women) and fasting blood sugar over 100 mg/dl). Exclusion criteria: Alcohol and tobacco consumption; Pregnancy; Lactation, Menopause; History of acute or chronic liver failure; Gastrointestinal diseases; Cholestasis; Diabetes, Kidney disease, Seizure, Autoimmune diseases, Thyroid disorders; Using estrogen, Hormone replacement therapy; Routine consumption of oral contraceptives, Insulin therapy; Malignancy; Routine consumption of antioxidants and vitamin/mineral supplements; Following vegetarian diet or any other special diet in the last 3 months. Intervention: Subjects will randomly receive either type of low carbohydrate diets for 12 weeks. Main outcome measures (variables): Weight changes, Body composition, Serum CTRP1, FGF-21, Chemerin, Asprosin, plasma levels of EMPs, Appetite regulatory hormones before and after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016121925267N4
Registration date: 2017-07-26, 1396/05/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-07-26, 1396/05/04
Registrant information
Name
Maryam Mahmoudi
Name of organization / entity
School of Nutritional Sciences & Dietetics, Tehran University of Medical Sciences,
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5975
Email address
m-mahmoudi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of low-carbohydrate (Paleo diet) and moderate-carbohydrate diet with two delivery mode; “fixed diet plan” vs “calorie counting” on body composition, serum levels of some hepatokines and adipocytokines and flowcytometric analysis of endothelial micro particles (EMPs) in adults with metabolic syndrome: A randomized clinical trial
Public title
Evaluating the efficacy of two types of low-carbohydrate diets on weight, metabolic and inflammatory factors in patients with metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria consists of: Age between 20 and 50 years old; Diagnosis of metabolic syndrome according to the NCEP-ATPIII criteria (If three or more of the following five criteria are met: Waist circumference over 40 inches (men) or 35 inches (women); Blood pressure over 130/85 mmHg; Fasting triglyceride (TG) level over 150 mg/dl; Fasting high-density lipoprotein (HDL) cholesterol level less than 40 mg/dl (men) or 50 mg/dl (women) and fasting blood sugar over 100 mg/dl). Exclusion criteria are: Alcohol and tobacco consumption; Pregnancy; Lactation; Menopause; History of acute or chronic liver failure; Acute or chronic gastrointestinal diseases, Cholestasis; Diabetes, Kidney disease, Seizure, Autoimmune diseases, Thyroid disorders; Using hormonal drugs such as estrogen, Hormone replacement therapy, Routine consumption of oral contraceptives, Insulin therapy; Malignancy or neoplasia; Routine consumption of antioxidants and vitamin/mineral supplements; Following vegetarian diet or any other special diet in the last 3 months.
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Balanced Block Randomization

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Qods St, Keshavarz blv, Tehran, Iran.
City
Tehran
Postal code
Approval date
2017-04-08, 1396/01/19
Ethics committee reference number
IR.TUMS.VCR.REC.1396.2046

Health conditions studied

1

Description of health condition studied
Metabolic Syndrome
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Weight
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Scale

2

Description
Body Composition
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Body Impedence Analysis

3

Description
Serum Asprosin
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
ELISA assay

4

Description
Serum Chemerin
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
ELISA assay

5

Description
FGF-21
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
ELISA assay

6

Description
Serum CTRP1
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
ELISA assay

7

Description
Plasma level of Endothelial Microparticles (CD 31,105, 146)
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Flowcytometry

8

Description
Appetite regulatory hormones (Peptide YY and ghrelin)
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
ELISA assay

Secondary outcomes

1

Description
Lipid profiles (TC, TG, LDL-C, HDL-C)
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Enzymatic methods for TC,TG and HDL-C For LDL-C : Freidwald’s formula: LDL-C = TC- HDL-C - (TG/5)

2

Description
Fasting blood glucose
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Enzymatic colorimetric

3

Description
Fasting insulin serum
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
ELISA assay

4

Description
Insulin resistance
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
HOMA-IR calculation

5

Description
Insulin sensitivity
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
QUICKI calculation

6

Description
Urine Sodium
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Electrolyte Analyzer

7

Description
Urine Potassium
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Electrolyte Analyzer

8

Description
HS-CRP
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
ELISA assay

9

Description
Appetite changes
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
VAS questionnaire

10

Description
Leptin
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
ELISA assay

11

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

Intervention groups

1

Description
Intervention group 4: Receiving moderate carbohydrate diet with “fixed diet plan” for 12 weeks. Medium-carbohydrate diet is defined as a 40% carbohydrate, 30% protein and 30% fat diet.
Category
Lifestyle

2

Description
Intervention group 3: Receiving moderate carbohydrate diet with calorie counting for 12 weeks. Medium-carbohydrate diet is defined as a 40% carbohydrate, 30% protein and 30% fat diet.
Category
Lifestyle

3

Description
Intervention group 1: Receiving paleo diet with calorie counting for 12 weeks. Low-carbohydrate paleo diet is defined as a 20% carbohydrate, 35% protein and 45% fat diet.
Category
Lifestyle

4

Description
Intervention group 2: Receiving paleo diet with “fixed diet plan” for 12 weeks. Low-carbohydrate paleo diet is defined as a 20% carbohydrate, 35% protein and 45% fat diet.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes and Metabolic diseases Clinic; Municipal Districts of Tehran
Full name of responsible person
Ms.Shariat
Street address
Building of Social and Cultural Affairs, Intersection of the Gomnam Shahid Autobahn, Kurdistan highway, Tehran, Iran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr.Masud Yunesian
Street address
Qods St, Keshavarz blv, Tehran, Iran.
City
Tehran
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, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr.Maryam Mahmoudi
Position
MD and PhD in Nutritional Sciences, Associate Professor
Other areas of specialty/work
Street address
No. 44, Hojatdoost Alley, Naderi St, Keshavarz blv, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8895 5569
Fax
Email
m-mahmoudi@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Maryam Mahmoudi
Position
MD and PhD in Nutritional Sciences, Associate Professor
Other areas of specialty/work
Street address
No. 44, Hojatdoost Alley, Naderi St, Keshavarz blv, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8895 5569
Fax
Email
m-mahmoudi@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farnosh Shemirani
Position
PhD student in Nutrition Sciences
Other areas of specialty/work
Street address
No. 44, Hojatdoost Alley, Naderi St, Keshavarz blv, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8895 5569
Fax
Email
sfarnosh@yahoo.com; jfaranush@gmail.com
Web page address

Sharing plan

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