IRCT | Effect of synbiotic and/or vitamin D on intestinal microbiome and its relationship with muscle strength, function and body composition in overweight or obese middle-aged women.

Protocol summary

Study aim: Determining the effect of synbiotic and/or vitamin D on intestinal microbiome and its relationship with muscle strength, function and body composition in overweight or obese middle-aged women
Design: RCT design. Eligible people from the staff of Shiraz university of medical sciences will enter the study. 88 people will randomly divide into 4 groups (vitamin D, synbiotic, vitamin D and synbiotic, placebo) based on permuted block randomization.
Settings and conduct: Eligible women from Shiraz University of Medical Sciences staff will enroll in the study and will receive 1 vitamin D supplement (or placebo) weekly and 1 synbiotic supplement (or placebo) daily for 8 weeks. Anthropometric variables (weight, height, body composition), strength and functional variables (handgrip strength and knee extension and TGUG test), intestinal microbiome and food intake will be measured at the beginning and end of the study. Double blind study (Participants and researcher).
Participants/Inclusion and exclusion criteria: Inclusion criteria: 1. Overweight and obese women aged 40-55 years 2. Not being menopaused. 3. Body mass index higher than 25 kg/m2 4. Willingness to participate Exclusion criteria: 1. Taking vitamin D supplements during the last 2-3 months, either orally or by injection 2. Consumption of synbiotic, probiotic and prebiotic supplements during the last 2-3 months 3. Having chronic diseases such as diabetes, CVD, liver and kidney disorders, uncontrolled blood pressure, etc. 4. Using vitamins, minerals, omega 3 or fish oil supplement 5. Use of antibiotics during the last three weeks 6. Following a special diet
Intervention groups: 1: Vitamin D supplement and synbiotic placebo 2: Vitamin D placebo and synbiotic supplement 3: Vitamin D and a synbiotic supplement 4: Vitamin D placebo and synbiotic placebo
Main outcome variables: Intestinal microbiome

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20090822002365N25

Registration date: 2021-03-03, 1399/12/13

Registration timing: prospective

Last update: 2021-03-03, 1399/12/13

Update count: 0
Registration date: 2021-03-03, 1399/12/13

Registrant information: Name

Mohammad Reza Vafa

Name of organization / entity

Iran University of Medical Sciences

Country

Iran (Islamic Republic of)

Phone

+98 21 8670 4734

Email address

vafa.m@iums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2021-04-21, 1400/02/01
Expected recruitment end date: 2021-08-23, 1400/06/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Effect of synbiotic and/or vitamin D on intestinal microbiome and its relationship with muscle strength, function and body composition in overweight or obese middle-aged women.

Public title: Effect of synbiotic with or without vitamin D on intestinal microbiome
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Overweight and obese women aged 40-55 years Not being menopaused Body mass index higher than 25 kg/m2 Willingness to participate in the study

Exclusion criteria:

Vitamin D intake during the last 2-3 months, either orally or by injection Taking supplements of synbiotics, probiotics and prebiotics during the last 2-3 months Having chronic diseases such as diabetes, cardiovascular disease, uncontrolled blood pressure, liver and kidney disorders, etc. Supplements intake containing vitamins, minerals and omega-3 or fish oil Antibiotic intake during the last three weeks Following a special diet Using steroidal and non-steroidal anti-inflammatory drugs, anticonvulsants, anti-cholesterol drugs, antacids, diuretics and and laxatives over the past two months Using any medications that affect weight over the past two months (such as medications that affect carbohydrate, protein or fat metabolism, and medications that reduce or increase appetite or food intake).
Age: From 40 years old to 55 years old
Gender: Female

Phase

2-3

Groups that have been masked

Participant
Investigator

Sample size

Target sample size: 88

Randomization (investigator's opinion)

Randomized

Randomization description

For randomized allocation performing, permuted block randomization will be used by quadrilateral blocks. According to the sample size of 88 subjects, 22 blocks will be generated using the online site (www.sealedenvelope.com). In order to allocation concealment in the randomized process, unique codes will be used on the drug boxes that is generated by the software. Participants will be entered into study based on the produced sequence. The drug packets will be allocated to the individual with code on them. Therefore, participants will be unaware of the type of intervention that will receive, as well as the random sequence which will be hidden and unpredictable.

Blinding (investigator's opinion)

Double blinded

Blinding description

For blinding, a person who will not be involved in study protocol will create the randomization list assigning participants to the vitamin D, synbiotic, co-supplementation or the placebo group. Vitamin D, synbiotic, and placebo tablets will be placed into identical containers and all investigators, and participants will be blinded to the random assignments.

Placebo

Used

Assignment

Factorial

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Iran University of Medical Sciences

Street address

Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences

City

Tehran

Province

Tehran

Postal code

۱۴۴۹۶۱۴۵۳۵
Approval date: 2021-01-31, 1399/11/12
Ethics committee reference number: IR.IUMS.REC.1399.1177

Health conditions studied

1

Description of health condition studied: overweight or obese middle-aged women
ICD-10 code: E66
ICD-10 code description: Overweight and obesity

Primary outcomes

1

Description: Intestinal microbiome
Timepoint: Intestinal microbiome assessment at the beginning of the study and after the intervention (end of week 8)
Method of measurement: Real-Time PCR TaqMan method

Secondary outcomes

1

Description: Muscle strength
Timepoint: At the beginning of the study and after the intervention (end of week 8)
Method of measurement: handgrip strength and knee extension

2

Description: Muscle function
Timepoint: At the beginning of the study and after the intervention (end of week 8)
Method of measurement: TGUG test

3

Description: Body composition
Timepoint: At the beginning of the study and after the intervention (end of week 8)
Method of measurement: multi-frequency Bioelectrical Impedance Analysis (BIA) and InBody S10 analyzer

Intervention groups

1

Description: Intervention group 1: Receiving one capsule of 50,000 IU of vitamin D (Zahravi company) weekly, along with one capsule of synbiotic placebo containing maltodextrin (Zist takhmir company) daily, for 8 weeks.
Category: Treatment - Drugs

2

Description: Intervention group 2: Receiving a 500 mg synbiotic capsule (Zist takhmir Company) daily, along with a vitamin D placebo capsule containing paraffin (Zahravi Company) weekly, for 8 weeks.
Category: Treatment - Drugs

3

Description: Intervention group 3: Receiving one 50,000 IU capsule of Vitamin D (Zahravi Company) weekly, along with receiving one 500 mg synbiotic capsule (Zist takhmir Company) daily, for 8 weeks.
Category: Treatment - Drugs

4

Description: Control group: Receiving a vitamin D placebo capsule containing paraffin (Zahravi Company) weekly, along with one capsule of synbiotic placebo containing maltodextrin (Zist takhmir company) daily, for 8 weeks.
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Shiraz university of medical sciences

Full name of responsible person

mohammad reza vafa

Street address

Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Hemmat Highway, Tehran, Iran

City

Tehran

Province

Tehran

Postal code

1449614535

Phone

+98 21 8670 4734

Fax

+98 21 8862 2707

Email

vafa.m@iums.ac.ir

1

Sponsor: Name of organization / entity

Iran University of Medical Sciences

Full name of responsible person

Mohammad reza Vafa

Street address

Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Hemmat Highway, Tehran, Iran

City

Tehran

Province

Tehran

Postal code

1449614535

Phone

+98 21 8670 4734

Fax

+98 21 8862 2707

Email

vafa.m@iums.ac.ir
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, Iran 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

Iran University of Medical Sciences

Full name of responsible person

Mohammad reza Vafa

Position

Professor

Latest degree

Ph.D.

Other areas of specialty/work

Nutrition

Street address

Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Hemmat Highway, Tehran, Iran

City

Tehran

Province

Tehran

Postal code

1449614535

Phone

+98 21 8670 4734

Email

vafa.m@iums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Iran University of Medical Sciences

Full name of responsible person

Mohammad reza Vafa

Position

Professor

Latest degree

Ph.D.

Other areas of specialty/work

Nutrition

Street address

Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Hemmat Highway, Tehran, Iran

City

Tehran

Province

Tehran

Postal code

1449614535

Phone

+98 21 8670 4734

Email

vafa.m@iums.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Iran University of Medical Sciences

Full name of responsible person

Mohammad reza vafa

Position

Professor

Latest degree

Ph.D.

Other areas of specialty/work

Nutrition

Street address

Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Hemmat Highway, Tehran, Iran

City

Tehran

Province

Tehran

Postal code

1449614535

Phone

+98 21 8670 4734

Email

vafa.m@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
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: Yes - There is a plan to make this available
Data Dictionary: Yes - There is a plan to make this available
Title and more details about the data/document: A part of the data will be shared, such as primary outcomes.
When the data will become available and for how long: Four months after the publication of the results.
To whom data/document is available: Researchers and students of university.
Under which criteria data/document could be used: Four months after the publication of this study papers, the obtained data will be available to the applicant researchers and students for further analysis.
From where data/document is obtainable: Applicants can be contacted with corresponding author by e-mail or postal address to receive the requested data. Postal address: Nutrition Department, School of health, Iran University of Medical Science, Hemmat Expressway, Tehran Phone Number: 0098 2186704743 E-mail: rezavafa@yahoo.com
What processes are involved for a request to access data/document: Applicants can be contacted with corresponding author by e-mail or postal address to receive the requested data. Postal address: Nutrition Department, School of health, Iran University of Medical Science, Hemmat Expressway, Tehran Phone Number: 0098 2186704743 E-mail: rezavafa@yahoo.com
Comments

Effect of synbiotic and/or vitamin D on intestinal microbiome and its relationship with muscle strength, function and body composition in overweight or obese middle-aged women.