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Assessment and comparison of the effects of two types of low calorie low carbohydrate and low fat diets on intestinal microbiota changes and its association with some of metabolic factors alterations in obese women

Protocol summary

Study aim
Determination and comparison of the effect of low carbohydrate and low fat-low calorie diets on weight and waist circumference alterations in obese women Determination and comparison of the effect of low carbohydrate and low fat-low calorie diets on fasting lipid profile, blood sugar and insulin alterations in obese women carbohydrate and low fat-low calorie diets on serum hs-CRP alterations in obese women Determination and comparison of the effect of low carbohydrate and low fat-low calorie diets on intestinal microbiota alterations in obese women
Design
Cross-over clinical trial, single blinded, randomized which is randomly assigned to 2 groups receiving low calorie-low fat and low carbohydrate diets.
Settings and conduct
obese women attending to the nutrition clinic receive low fat or low carbohydrate diet for 6 weeks, then 2 weeks washout and then exchange the diet groups again for 6 weeks.
Participants/Inclusion and exclusion criteria
inclusion criteria: body mass index higher than 30, age between 18-50 years, female exclusion criteria: antibiotic intake now/or at least at the one month ago, intake of probiotic supplements at least at the 3 month ago or during the study period, pregnancy and lactation, menopause, liver, kidney, cardiac diseases, gastrointestinal diseases and malabsorption, type 1 and 2 diabetes, cancer, hypothyroidism, special diets, alcohol intake or smoking, participants with compliance lower than 80%, vigorous exercise
Intervention groups
low fat diet group low carbohydrate diet group
Main outcome variables
weight, waist circumference, fasting lipid profile, fasting blood sugar and insulin, high sensitive C-reactive protein, intestinal microbiota

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200929048876N3
Registration date: 2021-01-08, 1399/10/19
Registration timing: prospective

Last update: 2021-01-08, 1399/10/19
Update count: 0
Registration date
2021-01-08, 1399/10/19
Registrant information
Name
Seyedeh Neda Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3315 6300
Email address
neda.mousavi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-09, 1399/10/20
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment and comparison of the effects of two types of low calorie low carbohydrate and low fat diets on intestinal microbiota changes and its association with some of metabolic factors alterations in obese women
Public title
Diet and intestinal microbiota alterations
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index equal or higher than 30 female ages of 18 to 50 year
Exclusion criteria:
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization will be used as two groups with 4-number blocks including 5 participant in each group. randomization unit is person and we will use random allocation software for this purpose. random coded boxes will be used for concealment. At this method, cans with similar weight, shape and color which are numbered according to the random sequence will be used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Zanjan University of Medical Sciences
Street address
Azadi Blv, Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2021-01-06, 1399/10/17
Ethics committee reference number
IR.ZUMS.REC.1399.350

Health conditions studied

1

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

Primary outcomes

1

Description
weight alterations
Timepoint
baseline and after 6 weeks
Method of measurement
scale

2

Description
fasting blood sugar alterations
Timepoint
baseline and after 6 weeks
Method of measurement
autoanalyzer setting

3

Description
fasting triglyceride alterations
Timepoint
baseline and after 6 weeks
Method of measurement
autoanalyzer setting

4

Description
total cholesterol alterations
Timepoint
baseline and after 6 weeks
Method of measurement
autoanalyzer setting

5

Description
LDL.C cholesterol alterations
Timepoint
baseline and after 6 weeks
Method of measurement
autoanalyzer setting

6

Description
HDL.C cholesterol alterations
Timepoint
baseline and after 6 weeks
Method of measurement
autoanalyzer setting

7

Description
Waist circumference alterarions
Timepoint
baseline and after 6 weeks
Method of measurement
centimeter

8

Description
intestinal microbiota alterations
Timepoint
baseline and after 6 weeks
Method of measurement
autoanalyzer setting

9

Description
blood pressure alterations
Timepoint
baseline and after 6 weeks
Method of measurement
autoanalyzer setting

10

Description
C-reactive protein alterations
Timepoint
baseline and after 6 weeks
Method of measurement
ELIZA kit

11

Description
serum insulin alterations
Timepoint
baseline and after 6 weeks
Method of measurement
ELIZA kit

12

Description
hip circumference alterations
Timepoint
baseline and after 6 weeks
Method of measurement
centimeter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention and control group: From the total daily calorie needs, 500 kcal per day will be reduce for 0.5 kg weight reduction in each patient. In low fat diet 20% of total daily calorie will receive from fat (with emphasis on mono and poly- unsaturated plant fatty acids), 15% from protein and 65% from carbohydrates.
Category
Lifestyle

2

Description
Control and intervention group: From the total daily calorie needs, 500 kcal per day will be reduce for 0.5 kg weight reduction in each patient. In low carbohydrate diet 20% of total daily calorie will receive from carbohydrate, 25% from protein and 55% from fats (with emphasis on mono and poly- unsaturated plant fatty acids).
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafieieh Clinic
Full name of responsible person
Dr. Hossein Chiti
Street address
Shariati St
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3315 6300
Email
dr.chiti@zums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Alireza Shoghli
Street address
Azadi Blv.
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3315 6400
Email
shoghli@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Karbalaei
Position
fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Valie-Asr Hospital, Shariati St
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3315 6300
Email
karbalaei.mahnaz@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Seyedeh Neda Mousavi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mahdavi Blv., 13th St.
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3315 6300
Email
neda.mousavi@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Neda Mousavi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mahdavi Blv., 13th St.
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3315 6300
Email
neda.mousavi@zums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
without participant name
When the data will become available and for how long
After study final
To whom data/document is available
All person
Under which criteria data/document could be used
All person
From where data/document is obtainable
Zanjan University of Medical Sciences, Deputy of Research and Thechnology
What processes are involved for a request to access data/document
straight referee to Deputy of Research and Technology of Zanjan University of Medical Sciences
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