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The effect of reduced-carbohydrate diet based on high fiber sources on food addiction and gut microbiota of obese adolescents

Protocol summary

Study aim
Determining the effect of reduced carbohydrate diet based on high fiber sources on anthropometric indices, metabolic parameters, food addiction and gastrointestinal microbiota in obese adolescents with food addiction
Design
Randomized clinical trial in parallel groups (control and intervention groups) with a sample size of 70 participants (35 participants in each group)
Settings and conduct
participants will be randomly assigned into two groups: control diet and reduced carbohydrate diet. Then they will receive their meal plan as a menu and detailed instructions. At the beginning and end of the study, weight, blood pressure, body fat percentage and dietary intakes will be recorded at the National Nutrition Research Institute. furthermore, blood and stool samples also will be collected. Participants will be followed up during the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Obese adolescents aged 19-12 years, with at least 3 symptoms of food addiction questionnaire and significant clinical disorder, willingness to participate in the study Exclusion criteria: taking antibiotics, taking supplements such as probiotics or prebiotics, participating in other weight loss programs and those with recent weight fluctuations, Suffering from any type of metabolic, renal, cardiovascular, thyroid, liver and gastrointestinal diseases, secondary obesity, history of eating disorders, current use Corticosteroid, use of medications to treat psychosis or mania-depression, history of surgery
Intervention groups
Individuals in the two groups receive a low-calorie diet with reduced carbohydrates based on high-fiber sources (intervention group) or a standard low-calorie diet (control group) for 3 months.
Main outcome variables
Weight, body mass index, body fat percentage, lipid profile, glucose, insulin, systolic and diastolic blood pressure, food addiction score, gut microbiota

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180805040703N2
Registration date: 2022-05-07, 1401/02/17
Registration timing: registered_while_recruiting

Last update: 2022-05-07, 1401/02/17
Update count: 0
Registration date
2022-05-07, 1401/02/17
Registrant information
Name
Golaleh Asghari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 9309
Email address
g_asghari@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of reduced-carbohydrate diet based on high fiber sources on food addiction and gut microbiota of obese adolescents
Public title
The effect of low carbohydrate diet on food addiction and gut microflora
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adolescents 12-19 years old Obese, body mass index higher than 2 standard deviations from the average standard set for age and sex by the World Health Organization for children or adolescents between 5-19 years Has at least 3 signs of food addiction questionnaire symptoms and significant clinical disorder or discomfort Willingness to participate in the study
Exclusion criteria:
Taking antibiotics for more than 3 days during the previous 3 months Taking medications or supplements such as probiotics or prebiotics that alter the gastrointestinal microbiota for more than 3 days in the past 1 month Participate in other weight loss programs in the previous 3 months and Suffering from any type of metabolic, renal, cardiovascular, thyroid, liver and gastrointestinal diseases Secondary obesity such as Cushing's syndrome, hypothyroidism, hypogonadal or pituitary obesity History of eating disorders Current use of corticosteroids for more than 5 days a month Use of medications to treat psychosis or manic-depressive illness such as lithium, carbamazepine, valproic acid History of surgery in the last 3 months (history of obesity surgery) History of weight fluctuations of more than 5 kg in the last 2 months
Age
From 12 years old to 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block randomization method will be used. 70 participants will be assigned into two groups of diets (A intervention diet and B control diet) using a computer randomization list. This list will be created through the randomization.com website (http://www.randomization.com). Considering 6 blocks and 12 subjects in each block, a list of 72 subjects will be assigned to different groups, which 2 of them will be deleted due to the sample size of 70. Individuals are assigned to two groups according to the order (from the first person number 1 to the last person number 70) who enter the study and according to the compiled randomization list. By researcher number 1, each person's number will be written on the envelope and the group will be placed inside a sealed envelope to ensure that the assigned order is hidden, and then the envelopes will be given to researcher number 2.
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
Ethics Committee of National Nutrition & Food Technology Research Institute
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2022-03-14, 1400/12/23
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1401.001

Health conditions studied

1

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

2

Description of health condition studied
food addiction
ICD-10 code
ICD-10 code description

3

Description of health condition studied
gut microbiota
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
weight
Timepoint
At the beginning and end of the study (3 months after starting the diet)
Method of measurement
Digital scales

2

Description
Body mass index
Timepoint
At the beginning and end of the study (3 months after starting the diet)
Method of measurement
calculation

Secondary outcomes

1

Description
Food Addiction Score
Timepoint
At the beginning and end of the study (3 months after starting the diet)
Method of measurement
Yale Food Addiction Scale

2

Description
Abundance of actionbacteria
Timepoint
At the beginning and end of the study (3 months after starting the diet)
Method of measurement
Polymerase chain reaction test

3

Description
Abundance of firmicutes
Timepoint
At the beginning and end of the study (3 months after starting the diet)
Method of measurement
Polymerase chain reaction test

4

Description
Abundance of bacteroidetes
Timepoint
At the beginning and end of the study (3 months after starting the diet)
Method of measurement
Polymerase chain reaction test

5

Description
Abundance of proteobacteria
Timepoint
At the beginning and end of the study (3 months after starting the diet)
Method of measurement
Polymerase chain reaction test

6

Description
Abundance of verrucomicrobia
Timepoint
At the beginning and end of the study (3 months after starting the diet)
Method of measurement
Polymerase chain reaction test

7

Description
Abundance of bifidobacterium
Timepoint
At the beginning and end of the study (3 months after starting the diet)
Method of measurement
Polymerase chain reaction test

8

Description
Abundance of Escherichia
Timepoint
At the beginning and end of the study (3 months after starting the diet)
Method of measurement
Polymerase chain reaction test

9

Description
Abundance of lactobacillus
Timepoint
At the beginning and end of the study (3 months after starting the diet)
Method of measurement
Polymerase chain reaction test

10

Description
Abundance of bacteroides
Timepoint
At the beginning and end of the study (3 months after starting the diet)
Method of measurement
Polymerase chain reaction test

11

Description
Abundance of prevotella
Timepoint
At the beginning and end of the study (3 months after starting the diet)
Method of measurement
Polymerase chain reaction test

12

Description
Percentage of body fat
Timepoint
At the beginning and end of the study (3 months after starting the diet)
Method of measurement
Bioelectrical impedance analysis

13

Description
waist circumference
Timepoint
At the beginning and end of the study (3 months after starting the diet)
Method of measurement
tape measure

14

Description
Average of total daily calorie intake
Timepoint
At the beginning of the study, 45 and 90 days after the start of the intervention (diet)
Method of measurement
24-hour food recall questionnaire

15

Description
Average total daily carbohydrate intake
Timepoint
At the beginning of the study, 45 and 90 days after the start of the intervention (diet)
Method of measurement
24-hour food recall questionnaire

16

Description
Average total daily protein intake
Timepoint
At the beginning of the study, 45 and 90 days after the start of the intervention (diet)
Method of measurement
24-hour food recall questionnaire

17

Description
Average total daily fat intake
Timepoint
At the beginning of the study, 45 and 90 days after the start of the intervention (diet)
Method of measurement
24-hour food recall questionnaire

18

Description
Average total daily fiber intake
Timepoint
At the beginning of the study, 45 and 90 days after the start of the intervention (diet)
Method of measurement
24-hour food recall questionnaire

19

Description
Average daily intake of saturated fatty acids
Timepoint
At the beginning of the study, 45 and 90 days after the start of the intervention (diet)
Method of measurement
24-hour food recall questionnaire

20

Description
Average daily intake of unsaturated fatty acids
Timepoint
At the beginning of the study, 45 and 90 days after the start of the intervention (diet)
Method of measurement
24-hour food recall questionnaire

21

Description
Fasting serum glucose concentration
Timepoint
At the beginning and end of the study (3 months after starting the diet)
Method of measurement
Colorimeter/ laboratory kit

22

Description
Fasting serum insulin concentration
Timepoint
At the beginning and end of the study (3 months after starting the diet)
Method of measurement
enzyme-linked immunosorbent assay/laboratory kit

23

Description
Total serum cholesterol level
Timepoint
At the beginning and end of the study (3 months after starting the diet)
Method of measurement
Colorimeter/ laboratory kit

24

Description
Serum triglyceride level
Timepoint
At the beginning and end of the study (3 months after starting the diet)
Method of measurement
Colorimeter/ laboratory kit

25

Description
serum Low density lipoprotein level
Timepoint
At the beginning and end of the study (3 months after starting the diet)
Method of measurement
calculation

26

Description
serum high density lipoprotein level
Timepoint
At the beginning and end of the study (3 months after starting the diet)
Method of measurement
Blood biochemical test / colorimetry

27

Description
Systolic blood pressure
Timepoint
At the beginning and end of the study (3 months after starting the diet)
Method of measurement
sphygmomanometer

28

Description
Diastolic blood pressure
Timepoint
At the beginning and end of the study (3 months after starting the diet)
Method of measurement
sphygmomanometer

Intervention groups

1

Description
Intervention group: 3 months low calorie diet with reduced carbohydrates based on high fiber sources
Category
Treatment - Other

2

Description
Control group: Standard low calorie diet
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrinology, Growth and Metabolism Clinic
Full name of responsible person
Yasaman Khorshidi
Street address
No. 10, Alley 26, Motahhari Intersection, Ghaem Magham Farahani St.
City
tehran
Province
Tehran
Postal code
1586985917
Phone
+98 21 8883 5403
Email
khorshidiyasaman@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Azita Hekmatdoost
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
nnftri_food@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Yasaman Khorshidi
Position
master of science student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No 7, Hafezi St, Farahzadi Blv, Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
khorshidiyasaman@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Golaleh Asghari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No 7, Hafezi St, Farahzadi Blv, Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
g_asghari@hotmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Yasaman Khorshidi
Position
master of science student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No 7, Hafezi St, Farahzadi Blv, Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
khorshidiyasaman@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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