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The Effects of butyrate supplementation on the expression levels of PGC-1α, PPARα and UCP1 genes, serum level of GLP-1, metabolic parameters, and anthropometric indices in obese individuals on a weight loss diet: A Triple- Blind, Randomized, Placebo- Controlled Clinical Trial.

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History
# Registration date Revision Id
2 2022-02-12, 1400/11/23 218685
1 2021-01-31, 1399/11/12 169340
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  • Primary outcomes

    #1
    empty
    Serum level of LBP
    empty
    سطح سرمی LBP
    empty
    Before the intervention and two months after the intervention
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    قبل مداخله و دو ماه بعد از مداخله
    empty
    Enzyme-linked immunosorbent assay (ELISA) kit
    empty
    کیت ELISA
    #2
    empty
    Gene expression of TNF-α
    empty
    بیان ژن TNF-α
    empty
    Before the intervention and two months after the intervention
    empty
    قبل مداخله و دو ماه بعد از مداخله
    empty
    Real time- PCR
    empty
    Real time- PCR
    #3
    empty
    Gene expression of TLR4
    empty
    بیان ژن TLR4
    empty
    Before the intervention and two months after the intervention
    empty
    قبل مداخله و دو ماه بعد از مداخله
    empty
    Real time- PCR
    empty
    Real time- PCR
    #4
    empty
    Gene expression of NFkB
    empty
    بیان ژن NFkB
    empty
    Before the intervention and two months after the intervention
    empty
    قبل مداخله و دو ماه بعد از مداخله
    empty
    Real time- PCR
    empty
    Real time- PCR
    #5
    empty
    population of Lactobacilli in gut microbiota
    empty
    جمعیت لاکتوباسیلوس ها در میکروبیوتای روده
    empty
    Before the intervention and two months after the intervention
    empty
    قبل مداخله و دو ماه بعد از مداخله
    empty
    Real time- PCR
    empty
    Real time- PCR
    #6
    empty
    population of Bifidobacteria in gut microbiota
    empty
    جمعیت بیفیدوباکتریوم ها در میکروبیوتای روده
    empty
    Before the intervention and two months after the intervention
    empty
    قبل مداخله و دو ماه بعد از مداخله
    empty
    Real time- PCR
    empty
    Real time- PCR
    #7
    empty
    population of Lachnospiraceae in gut microbiota
    empty
    جمعیت لاکنوسپیراسه در میکروبیوتای روده
    empty
    Before the intervention and two months after the intervention
    empty
    قبل مداخله و دو ماه بعد از مداخله
    empty
    Real time- PCR
    empty
    Real time- PCR
    #8
    empty
    Malondialdehyde(MDA)
    empty
    مالون دی آلدهید
    empty
    Before the intervention and two months after the intervention
    empty
    قبل مداخله و دو ماه بعد از مداخله
    empty
    MDA kit
    empty
    کیت MDA
    #9
    empty
    glutathione peroxidase(GPX)
    empty
    گلوتاتیون پراکسیداز
    empty
    Before the intervention and two months after the intervention
    empty
    قبل مداخله و دو ماه بعد از مداخله
    empty
    GPX kit
    empty
    کیت GPX
    #10
    empty
    superoxide dismutase (SOD)
    empty
    سوپراکسید دیسموتاز
    empty
    Before the intervention and two months after the intervention
    empty
    قبل مداخله و دو ماه بعد از مداخله
    empty
    SOD kit
    empty
    کیت SOD

  • Recruitment centers

    #1
    Name of recruitment center - English: Health centers of Tabriz University of Medical Sciences
    Name of recruitment center - Persian: مراکز درمانی دانشگاه علوم پزشکی تبریز
    Full name of responsible person - English: سید احمد حسینی
    Full name of responsible person - Persian: Seyed Ahmad Hosseini
    Street address - English: School of Nutrition and Food Sciences, Golgasht Street
    Street address - Persian: خیابان گلگشت، خیابان عطار نیشابوری، دانشکده تغذیه
    City - English: Tabriz
    City - Persian: تبریز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 5166614711
    Phone: +98 41 3335 7580
    Fax:
    Email: seyedahmadhosseini@yahoo.com
    Web page address:
    Name of recruitment center - English: School of Nutrition and Food Sciences, Tabriz University of Medical Sciences
    Name of recruitment center - Persian: دانشکده تغذیه دانشگاه علوم پزشکی تبریز
    Full name of responsible person - English: Maryam saghafi-asl
    Full name of responsible person - Persian: مریم ثقفی اصل
    Street address - English: School of Nutrition and Food Sciences, Golgasht Street
    Street address - Persian: خیابان گلگشت، خیابان عطار نیشابوری، دانشکده تغذیه
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166614711
    Phone: +98 41 3335 7580
    Fax:
    Email: saghafiaslm@gmail.com
    Web page address:

Protocol summary

Study aim
Determination of the effects of butyrate supplementation on the expression levels of PGC-1α, PPARα and UCP1 genes, serum level of GLP-1, metabolic parameters, and anthropometric indices in obese individuals on a weight loss diet
Design
A clinical trial with the control group, with parallel groups, triple-blind, randomized, phase 2 on 50 patients. For randomization, block design is used.
Settings and conduct
Referred to Nutrition Faculty of Tabriz University of Medical Sciences in 2021, selection of 50 patients based on inclusion and exclusion criteria, randomization into intervention and control groups. Blinding of patients and researchers, coding by a third party who does not know the details.
Participants/Inclusion and exclusion criteria
Inclusion criteria: body mass index 30 to 40, both females and males, age between 18 to 60 years Non-inclusion criteria: unwillingness to continue the study, kidney diseases, liver failure, heart failure, rheumatic diseases, diabetes, malignancies, and gastrointestinal diseases, taking any supplements, taking weight-loss drugs and following a weight loss diet, history of obesity surgery, smoking, pregnancy, lactation, menopause
Intervention groups
The intervention group: one butyrate capsule of 600mg/day (made by Body Bio company, USA, containing 550 mg of butyrate and 50 mg sodium hydroxide, medium-chain triglycerides (MCT), hydroxypropyl methylcellulose, and purified water) for 60 days. The control group: one placebo capsule of 600 mg/day (compounds similar to supplement except for butyrate) for 60 days
Main outcome variables
weight, body mass index, waist circumference, waist circumference, fat mass, lean mass; serum level of GLP-1; gene expression of PGC-1α, PPARα, UCP1; lipid factors, fasting glucose, alanine aminotransferase, aspartate aminotransferase, insulin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190303042905N2
Registration date: 2021-01-31, 1399/11/12
Registration timing: prospective

Last update: 2022-03-02, 1400/12/11
Update count: 1
Registration date
2021-01-31, 1399/11/12
Registrant information
Name
Parichehr َAmiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5503
Email address
amiriparichehr70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of butyrate supplementation on the expression levels of PGC-1α, PPARα and UCP1 genes, serum level of GLP-1, metabolic parameters, and anthropometric indices in obese individuals on a weight loss diet: A Triple- Blind, Randomized, Placebo- Controlled Clinical Trial.
Public title
Effect of butyrate in obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index (BMI) between 30-40 Both of genders female and male Age between 18-60 years old
Exclusion criteria:
Unwillingness to participate in the study Kidney diseases, liver failure, heart failure, rheumatic diseases, diabetes, malignancies, and gastrointestinal diseases Consumption of any product or supplement containing probiotics, prebiotics and antibiotics in the last 1 month Taking vitamin, fiber, omega-3, antioxidant supplements during the 3 weeks before and during the study Taking weight-loss drugs and following a weight loss diet for the past six months History of bariatric surgery Smoking Pregnancy, lactation, menopause
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Based on inclusion criteria, 50 patients will randomly allocated to placebo (n = 25) or intervention (n = 25) groups. Block design based on the combined analysis and using packed envelopes is used for randomization. In fact, according to the pattern and using two codes of A and B 6 groups with 4 blocks are selected. This work is repeated in 2 steps. In the end, two A and B codes are assigned to the 2 last patients and the randomization is completed (50 patients).
Blinding (investigator's opinion)
Triple blinded
Blinding description
The researchers and patients will not inform of the contents of the packets. A third person of health care does the coding. This person will not aware of the details of the research trial.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2021-01-27, 1399/11/08
Ethics committee reference number
IR.AJUMS.REC.1399.845

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 the intervention and two months after the intervention
Method of measurement
Using scales

2

Description
Waist circumference
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Using tape

3

Description
Body mass index(BMI)
Timepoint
Before the intervention and two months after the intervention
Method of measurement
By dividing weight (kg) to height square (m2)

4

Description
Waist to hip ratio(WHR)
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Waist circumference/hip circumference

5

Description
Fat mass(FM)
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Using bioelectrical impedence analyser

6

Description
Fat free mass(FFM)
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Using bioelectrical impedence analyser

7

Description
Serum level of GLP-1
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kit

8

Description
Gene expression of PGC-1α
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Real time- PCR

9

Description
Gene expression of PPARα
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Real time- PCR

10

Description
Gene expression of UCP1
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Real time- PCR

11

Description
Serum level of LBP
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kit

12

Description
Gene expression of TNF-α
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Real time- PCR

13

Description
Gene expression of TLR4
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Real time- PCR

14

Description
Gene expression of NFkB
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Real time- PCR

15

Description
population of Lactobacilli in gut microbiota
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Real time- PCR

16

Description
population of Bifidobacteria in gut microbiota
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Real time- PCR

17

Description
population of Lachnospiraceae in gut microbiota
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Real time- PCR

18

Description
Malondialdehyde(MDA)
Timepoint
Before the intervention and two months after the intervention
Method of measurement
MDA kit

19

Description
glutathione peroxidase(GPX)
Timepoint
Before the intervention and two months after the intervention
Method of measurement
GPX kit

20

Description
superoxide dismutase (SOD)
Timepoint
Before the intervention and two months after the intervention
Method of measurement
SOD kit

Secondary outcomes

1

Description
Serum levels of Triglyceride
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Using enzymatic kit method

2

Description
Serum levels of High-Density Lipoprotein cholesterol (HDL-c)
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Using enzymatic kit method

3

Description
Serum levels of High-Density Lipoprotein cholesterol (LDL-c)
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Using enzymatic kit method

4

Description
Fasting blood sugar
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Using enzymatic kit method

5

Description
Serum levels of alanine transaminase (ALT)
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Using enzymatic kit method

6

Description
Serum levels of aspartate aminotransferase (AST)
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Using enzymatic kit method

7

Description
Serum levels of insulin
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kit

Intervention groups

1

Description
Intervention group: one butyrate capsule of 600mg/day (made by Body Bio company, USA, containing 550 mg of butyrate and 50 mg sodium hydroxide, medium-chain triglycerides (MCT), hydroxypropyl methylcellulose, and purified water) for 60 days
Category
Treatment - Other

2

Description
Control group: one placebo capsule of 600 mg/day (compounds similar to supplement except for butyrate) for 60 days
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Nutrition and Food Sciences, Tabriz University of Medical Sciences
Full name of responsible person
Maryam saghafi-asl
Street address
School of Nutrition and Food Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
saghafiaslm@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Parichehr Amiri
Position
Ph.D. student of Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, School of Allied Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan St., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
7853167465
Phone
+98 21 5566 7924
Email
amiriparichehr70@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyed Ahmad Hosseini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Department of Nutrition, School of Allied Medical Sciences, Jundishapur University of Medical Sciences, Golestan St., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6163764754
Phone
+98 74 3333 1257
Email
seyedahmadhosseini@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parichehr Amiri
Position
Ph.D. student of Nutrition science
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, School of Allied Medical Sciences, Jundishapur University of Medical Sciences, Golestan St., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
7853167465
Phone
+98 21 5566 7924
Email
amiriparichehr70@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
The person's information will be confidential and the results will be as collective statistics
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
This clinical trial will be a research article and its protocol, results report and statistical analysis will be published to be used by therapists and researchers.
When the data will become available and for how long
If the journal requests access to the data at any time, the data will be provided.
To whom data/document is available
Journal editors and Reviewers
Under which criteria data/document could be used
Sometimes for re-analysis or for use in meta-analysis studies
From where data/document is obtainable
Project manager
What processes are involved for a request to access data/document
It should send an email to the project manager and after reviewing the reason for requesting the data, they will be sent
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