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The Effects of butyrate supplementation on plasma atherogenic index(AIP), serum level of hsCRP, expression level of adiponectin receptors(AdipoR1& R2), AMP activated protein kinase(AMPK) and uncoupling proteins(UCP2&3) genes in Obese individuals on a weight loss diet: A Randomized, Triple- Blind, Placebo- Controlled Clinical Trial

Protocol summary

Study aim
Determination of the effects of sodium butyrate supplementation on the atherogenic index of plasma(AIP), serum levels of hsCRP, the expression levels of adiponectin receptors(AdipoR1& R2), uncoupling proteins(UCP2&3) and peroxisome proliferator-activated receptor α (PPARα) genes in Obese individuals
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
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
ََAtherogenic index of plasma(AIP), serum levels of hsCRP, expression levels of adiponectin receptors(AdipoR1& R2), uncoupling proteins(UCP2&3) and peroxisome proliferator-activated receptor α (PPARα)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190303042905N3
Registration date: 2021-06-22, 1400/04/01
Registration timing: prospective

Last update: 2021-06-22, 1400/04/01
Update count: 0
Registration date
2021-06-22, 1400/04/01
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
2021-06-27, 1400/04/06
Expected recruitment end date
2021-11-01, 1400/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of butyrate supplementation on plasma atherogenic index(AIP), serum level of hsCRP, expression level of adiponectin receptors(AdipoR1& R2), AMP activated protein kinase(AMPK) and uncoupling proteins(UCP2&3) genes in Obese individuals on a weight loss diet: A Randomized, Triple- Blind, Placebo- Controlled Clinical Trial
Public title
The Effects of sodium butyrate supplementation on 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 Taking weightloss drugs and following a weight loss diet 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 random allocation software(RAS)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 iscompleted (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 Tabriz University of Medical Sciences
Street address
Golghasht Street,Tabriz University of Medical Sciences, second centeral building,third floor
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2021-05-31, 1400/03/10
Ethics committee reference number
IR.TBZMED.REC.1400.235

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
Gene expression level of AdipoR1& R2
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Real- time PCR

2

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

3

Description
Gene expression level of UCP 2 & 3
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Real- time PCR

Secondary outcomes

1

Description
Serum levels of hsCRP
Timepoint
Before the intervention and two months after the intervention
Method of measurement
ELISA kit

2

Description
Atherogenic index of plasma(AIP)
Timepoint
Before the intervention and two months after the intervention
Method of measurement
based on formula: AIP=log⁡〖triglycerides /high density lipoprotein〗

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

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers of Tabriz University of Medical Sciences
Full name of responsible person
Neda Roshanravan
Street address
School of Nutrition and Food Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Fax
+98 41 3335 7580
Email
Neda.roshanravan10@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Ghaffari
Street address
Cardiac Research Center-First Floor - Shahid Madani Cardiovascular Education and Research Center - Daneshgah St
City
Tabriz
Province
East Azarbaijan
Postal code
5166615573
Phone
+98 41 3337 3958
Fax
+98 41 3337 3958
Email
ghafaris@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, khuzestan, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
4445561358
Phone
+98 21 4568 9745
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
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, khuzestan, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
4445561358
Phone
+98 21 4568 9745
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
No - There is not 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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