IRCT | 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.

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

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
Comments

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.