IRCT | Comparing the effects of yogurt containing Akkermansia Muciniphilia postbiotic with yogurt containing Lactobacillus Rhamnosus postbiotic on body composition, anthropometric and biochemical indices, appetite, and depression scores in overweight or obese adults: a Randomized, double-blind, controlled clinical trial

Protocol summary

Study aim: Comparing the effect of yogurt containing Akk.muciniphila postbiotic with yogurt containing Lactobacillus rhamnosus postbiotic on body composition, anthropometric, and biochemical indices in obese or overweight adults
Design: This study is a randomized, double-blinded, phase 3 controlled clinical trial with three parallel groups (2 intervention and one control groups). 66 individuals (22 in each group) were randomized into groups with balanced-blocked randomization.
Settings and conduct: 66 eligible individuals referred to Imam Reza clinic,Shiraz, after becoming informed and obtaining informed consent, are randomly assigned into 3 study groups.They receive group yogurts, which are named the same as the groups with the letters A, B and C to blind the participant and the researcher and they take it daily before meals for 8weeks. Body composition, anthropometric and biochemichal indices and appetite and depression scores will be assessed before and after the study
Participants/Inclusion and exclusion criteria: Inclusion criteria: overweight or obese individuals aged 20-50 and Not being menopause for females. Not suffering from metabolic,endocrine,chronic diseases, Covid-19, or any kind of infection; Not hospitalized, didn't use antibiotics, prebiotic and probiotic supplements or any medication or supplement for 3 months before the study.Not following special diets for 1 month before the study Exclusion criteria:Pregnancy and lactation
Intervention groups: Intervention group1:22 participants will consume 120cc of yogurt containing 10^10 TFU Akkermansia muciniphila postbiotic 30min befor meal daily for 8 weeks Intervention group2: 22 participants will consume 120cc of yogurt containing 10^10TFU Lactobacillus rhamnosus postbiotic 30min befor meal daily for 8weeks Control group:22 participants will consume 120cc of low fat yogurt 30min befor meal daily for 8weeks
Main outcome variables: WC,weight,BMI

General information

Reason for update: Due to the lack of access to the probiotic Lactobacillus Acidophilus as one of the interventions of the study, Lactobacillus rhamnosus is replaced and because effects of Ackermansia muciniphila postbiotic are safer and more than its probiotic, therefore we decide to use the postbiotic instead of probiotic in the study.
Acronym
IRCT registration information: IRCT registration number: IRCT20230522058257N1

Registration date: 2023-11-04, 1402/08/13

Registration timing: registered_while_recruiting

Last update: 2024-10-22, 1403/08/01

Update count: 1
Registration date: 2023-11-04, 1402/08/13

Registrant information: Name

Erfaneh Aalipanah

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 71 3638 4944

Email address

aalipanah@sums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2023-09-23, 1402/07/01
Expected recruitment end date: 2024-01-20, 1402/10/30
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Comparing the effects of yogurt containing Akkermansia Muciniphilia postbiotic with yogurt containing Lactobacillus Rhamnosus postbiotic on body composition, anthropometric and biochemical indices, appetite, and depression scores in overweight or obese adults: a Randomized, double-blind, controlled clinical trial

Public title: Comparing the effects of yogurt containing Akkermansia Muciniphilia postbiotic with yogurt containing Lactobacillus Rhamnosus postbiotic on body composition, anthropometric and biochemical indices, appetite, and depression scores in overweight or obese adults
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Aged 20 - 50 years and not being menopause for females Being overweight or obese (Body mass index higher than 25) Not allergic to milk protein and Not lactose intolerant,not being gluten-intolerant Not suffering from known endocrine-related obesity, Inflammatory bowel disease, Irritable bowel syndrome, nouropathy, gastroparesis and gastrointestinal disorders at the beginning of the study Not suffering from thyroid diseases, diabetes, kidney disease, rheumatic diseases and migraine headache at the baseline did not use antibiotics for 2 months before the beginning of the study didn't take probiotic, prebiotic, and omega 3 supplements for 1month before the study Not taking part in other studies for 6 months before the study No weight reduction over 6 Kg in the last 3 months prior to the study no history of hospitalization or any surgery and bariateric surgery for 3 months before the study and 6 months after entering the study Not following special diets such as vegetarian or gluten free or weight-reducing diets Not infected with Covid-19 or any other infections or any hospitalization for 1 month before the study

Exclusion criteria:

planning for pregnancy for 6 months after the study and not having breast-feeding heavy alcohol use
Age: From 20 years old to 50 years old
Gender: Both

Phase

3

Groups that have been masked

Participant
Investigator

Sample size

Target sample size: 66

Randomization (investigator's opinion)

Randomized

Randomization description

Randomization will perform using the random block method (1: 1: 1 ratio) for three groups (one control and two intervention groups). In this method, blocks of three with rotation will be created by an out-of-study person. Then, a block will be randomly selected to determine the groups assigned to the first three participants. The random-blocks selection process will be repeated to determine the random allocation for the entire sample size. For allocation concealment, after determining the random sequence, these sequences will be placed in numbered sealed opaqued envelopes for each participant. An out-of-study person familiar with randomization will perform this process. During the study, by entering any participant in the study, based on the sequence, an envelope will be opened and the allocated group will be revealed.

Blinding (investigator's opinion)

Double blinded

Blinding description

In this study, for blinding the interventions, enriched yogurts (including two types of yogurts) and placebo are the same in terms of color, odor, and taste and will be named A, B, and C. The process of filling yogurt containers and naming them will be done by an out-of-study person. Therefore, in this study, the research team and the participants of different groups will be blinded to the type of the interventions or placebo consumed by each participant in order to observe the principles of blinding.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Research Ethics Committees of Schools of Health and Nutrition-Shiraz University of Medical Sciences

Street address

School of Health and Nutrition, Razi Blvd., Shiraz

City

Shiraz

Province

Fars

Postal code

7134814336
Approval date: 2023-05-21, 1402/02/31
Ethics committee reference number: IR.SUMS.SCHEANUT.REC.1402.073

Health conditions studied

1

Description of health condition studied: Overweight and obesity
ICD-10 code: E66
ICD-10 code description: Overweight and obesity

Primary outcomes

1

Description: waist circumference
Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement: stadiometer

2

Description: body weight
Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement: scale

3

Description: body mass index
Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement: By calculating using the formula with using height and weight

Secondary outcomes

1

Description: percent of body fat
Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement: Body composition analyzer

2

Description: Lipopolysaccharide (LPS)
Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement: Enzyme-linked immuno_sorbent assay (ELISA) kit

3

Description: High-sensitivity C-reactive Protein (hs-CRP) blood level
Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement: Enzyme-linked immuno_sorbent assay (ELISA) kit

4

Description: visceral body fat
Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement: Body composition analyzer

5

Description: Lean body mass
Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement: Body composition analyzer

6

Description: waist to hip ratio
Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement: flexible meter

7

Description: malondialdehyde (MDA)
Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement: spectrophotometry

8

Description: Appetite score
Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement: VAS questionnaire

9

Description: depression score
Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement: beck questionnaire

10

Description: total antioxidant capacity (TAC)
Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement: colorimetric method

11

Description: waist circumference to height
Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement: flexible meter

12

Description: triglyceride
Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement: colorimetric method

13

Description: total cholestrol
Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement: colorimetric method

14

Description: LDL (low-density lipoprotein)
Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement: colorimetric method

15

Description: HDL (high-density lipoprotein)
Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement: colorimetric method

16

Description: fasting blood sugar (FBS)
Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement: colorimetric method

17

Description: Alanine transaminase (ALT)
Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement: colorimetric method

18

Description: Aspartate transaminase (AST)
Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement: colorimetric method

19

Description: Physical activity
Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement: met questionnaire

20

Description: food intake
Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention)
Method of measurement: 24-hour dietary recall (24hr)

Intervention groups

1

Description: Intervention group 1: consume 120 cc of yogurt containing 10^10 TFU Ackermansia muciniphila postbiotic befor meal daily for 8 weeks.
Category: Treatment - Other

2

Description: Intervention group 2: consume 120 cc of yogurt containing 10^10 TFU Lactobacillus Rhamnosus postbiotic befor meal daily for 8 weeks.
Category: Treatment - Other

3

Description: Control group: consume 120 cc of low fat yogurt befor meal daily for 8 weeks.
Category: Treatment - Other

Recruitment centers

1

Recruitment center: Name of recruitment center

Imam Reza clinic

Full name of responsible person

Zahra Sohrabi

Street address

Imam Reza clinic, Zand St., Namazi Sq., Shiraz

City

Shiraz

Province

Fars

Postal code

7134814734

Phone

+98 71 3725 1002

Email

Zahra_2043@yahoo.com

1

Sponsor: Name of organization / entity

Shiraz University of Medical Sciences

Full name of responsible person

Zahra Sohrabi

Street address

Shiraz University of Medical Sciences, Zand St., Shiraz

City

Shiraz

Province

Fars

Postal code

7134814336

Phone

+98 71 3235 7282

Email

Sohrabi@sums.ac.ir
Grant name
Grant code / Reference number: 27971
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Shiraz 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

Shiraz University of Medical Sciences

Full name of responsible person

Erfaneh Aalipanah

Position

Ph.D. Candidate

Latest degree

Master

Other areas of specialty/work

Nutrition

Street address

School of Nutrition and Food Sciences, Razi Blvd., Shiraz

City

Shiraz

Province

Fars

Postal code

7134814336

Phone

+98 71 3725 8099

Email

E.Aalipanah71@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Shiraz University of Medical Sciences

Full name of responsible person

Zahra Sohrabi

Position

Associate professor

Latest degree

Ph.D.

Other areas of specialty/work

Nutrition

Street address

School of Nutrition and Food Sciences, Razi Blvd., Shiraz

City

Shiraz

Province

Fars

Postal code

7134814336

Phone

+98 71 3725 8099

Email

zahra_2043@yahoo.com

Person responsible for updating data

Contact: Name of organization / entity

Shiraz University of Medical Sciences

Full name of responsible person

Erfaneh Alipanah

Position

Ph.D. Candidate

Latest degree

Master

Other areas of specialty/work

Nutrition

Street address

School of Nutrition and Food Sciences, Razi Blvd., Shiraz

City

Shiraz

Province

Fars

Postal code

7134814336

Phone

+98 71 3725 8099

Email

e.aalipanah71@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: Undecided - It is not yet known if there will be a plan to make this available
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: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available