Protocol summary

Study aim
Determining the effects of ketogenic diet on weight management and apptite in overweight or obese individuals with weight regain and food addiction
Design
Clinical trial with control group, with parallel, randomized groups, on 50 obese or overweight adults. Excel software rand function was used for randomization.
Settings and conduct
Candidates are asked to attend the nutrition clinic of Shahid Beheshti University at the beginning and end of the project. After filling out the required consent and questionnaires, blood samples are taken, the physical composition of the volunteers is measured with an InBody device, stool samples are taken from the volunteers. And finally a proper diet is given to people.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Healthy adults who are obese or overweight with weight regain with food addiction Exclusion criteria: Gout and chronic diseases such as diabetes, cardiovascular, liver, etc. Neurological diseases (depression, bipolar disorder, and obsessive-compulsive disorder) Follow a special diet, use drugs that affect appetite and weight, and use any probiotic product in one recent month of antibiotic use in the last month.
Intervention groups
Obese or overweight adults with recurrent weight regain with food addiction Ketogenic diet for intervention group Dietary control group with calorie restriction
Main outcome variables
plasma serotonin level, plasma BDNF level, eating behavior, weight, body mass index, waist circumference, hip circumference, waist to hip ratio, fat mass percentage Body, percentage of lean body mass, weight of body fat mass, body weight of lean body mass, percentage of visceral body fat, amount of visceral body fat, appetite, Bacteroides abundance, Lactobacillus abundance, Bifidobacterium abundance, Megamonas abundance, Eubacterium abundance, Akkermansia abundance, Urine ketone

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220418054574N1
Registration date: 2022-06-13, 1401/03/23
Registration timing: registered_while_recruiting

Last update: 2022-06-13, 1401/03/23
Update count: 0
Registration date
2022-06-13, 1401/03/23
Registrant information
Name
Ali Zamanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7632 8409
Email address
alitimeeee@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-05, 1401/02/15
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of ketogenic diet on weight management and appetite status in overweight or obese adults with food addiction and weight regain
Public title
Effect of kettogenic diet on weight management and apptite
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Overweight or obese people between 18-60 years old Body mass index 40-26 kg / m2 Food addiction based on YFAS4 questionnaire Weight regain One-third to two-thirds of the weight lost in 1 year, or almost all of them in 5 years Do not be pregnant or breastfeeding
Exclusion criteria:
gout and chronic diseases such as diabetes, cardiovascular, liver, etc. mental illness (depression, bipolar disorder and obsessive-compulsive disorder) Failure to follow a specific diet take drugs that affect appetite and weight use any probiotic products in a recent month use antibiotics during the last month
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, participants were classified into two groups with overweight (26-30) and obesity grade 2 (30-40) by stratified blocked randomization method and based on BMI and randomly assigned to One of the groups TRF or control group. Separate randomization is done based on BMI within each group. The size of the blocks is 4, with two assignments to the intervention group (A) and two allocations to the control group (B). There are 6 different permutations of AABB, ABAB, BBAA, BABA, ABBA, BAAB.
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 Shahid Beheshti University of Medical Sciences
Street address
No. 7, Hafezi (Arghavan) Ave., Farahzadi Ave., Shahrake Qods(Gharb) town, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2022-04-18, 1401/01/29
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1401.003

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
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
seca scale

2

Description
Body Mass Index
Timepoint
before intervention, 4 weeks and 8 weeks after intervention
Method of measurement
Calculation (kg/m2)

3

Description
Waist circumference
Timepoint
before intervention, 4 weeks and 8 weeks after intervention
Method of measurement
Meter strip

4

Description
Fat Mass
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
Bio Impedance Analyzer

5

Description
Fat Free Mass
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
Bio Impedance Analyzer

Secondary outcomes

1

Description
serum serotonin level
Timepoint
before intervention, 8 weeks after intervention
Method of measurement
Elisa

2

Description
serum BDNF
Timepoint
before intervention, 8 weeks after intervention
Method of measurement
Elisa

3

Description
gut microbiota
Timepoint
before intervention, 8 weeks after intervention
Method of measurement
PCR

Intervention groups

1

Description
Intervention group:Get a ketogenic diet with calorie restriction for 8 weeks
Category
Treatment - Other

2

Description
Control group: Get low calorie diet with calorie restriction for 8 weeks
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
nutrition clinic of Shahid Beheshti university of medical science
Full name of responsible person
Ali Zamanian
Street address
Baran Ave., Hafezi (Arghavan) Ave., Farahzadi Ave., Shahrake Qods(Gharb) town, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2237 6420
Email
alitimeeee@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical sciences- School of Nutrition
Full name of responsible person
Dr. Azita hekmatdust
Street address
No. 7, Hafezi (Arghavan) Ave., Farahzadi Ave., Shahrake Qods(Gharb) town, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
a_hekmat2000@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research, Shahid Beheshti University of Medical sciences- School of Nutrition
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
Ali Zamanian
Position
Master student of nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
NO. 7, Hafezi (Arghavan) Ave., Farahzadi Blvd, Qods (Gharb) twon, Tehran
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
alitimeeee@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atoosa Saidpour
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, Hafezi (Arghavan) Ave., Farahzadi Blvd., Qods (Gharb) twon, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7384
Email
Atoosa.saidpour@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Zamanian
Position
Master student of nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
NO. 7, Hafezi (Arghavan) Ave., Farahzadi Blvd, Qods (Gharb) twon, Tehran
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
alitimeeee@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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