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
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Protocol summary
Comparing the effect of yogurt containing Akk.muciniphila with yogurt containing Lactobacillus acidophilus on body composition, anthropometric, and biochemical indices in obese or overweight adults
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
Comparing the effect of yogurt containing Akk.muciniphila postbiotic with yogurt containing Lactobacillus acidophilusrhamnosus postbiotic on body composition, anthropometric, and biochemical indices in obese or overweight adults
مقایسه اثر ماست حاوی آکرمانسیا موسینیفیلا با ماست حاوی لاکتوباسیلوس اسیدوفیلوس بر ترکیب بدن، شاخص های تن سنجی و بیوشیمیایی در بزرگسالان با اضافه وزن یا چاقی
مقایسه تاثیر مصرف ماست حاوی پست بیوتیک آکرمانسیا موسینیفیلا با ماست حاوی پست بیوتیک لاکتوباسیلوس رامنوسوس بر شاخص های تن سنجی و بیوشیمیایی، نمره اشتها و افسردگی در افراد دارای اضافه وزن و چاقی
مقایسه اثرتاثیر مصرف ماست حاوی پست بیوتیک آکرمانسیا موسینیفیلا با ماست حاوی پست بیوتیک لاکتوباسیلوس اسیدوفیلوسرامنوسوس بر ترکیب بدن، شاخص های تن سنجی و بیوشیمیایی، نمره اشتها و افسردگی در بزرگسالان باافراد دارای اضافه وزن یاو چاقی
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 8 weeks. Body composition, anthropometric and biochemichal indices and appetite and depression scores will be assessed before and after the study
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
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 8 weeks8weeks. Body composition, anthropometric and biochemichal indices and appetite and depression scores will be assessed before and after the study
Inclusion criteria: overweight or obese individuals aged 20 to 50 and Not being menopause for females. Not suffering from metabolic,endocrine,chronic diseases, Covid-19, or any kind of infection; Not hospitalized for 3 months before the study, 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
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
Inclusion criteria: overweight or obese individuals aged 20 to -50 and Not being menopause for females. Not suffering from metabolic,endocrine,chronic diseases, Covid-19, or any kind of infection; Not hospitalized for 3 months before the study, 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 group1: 22 participants will consume 120cc of yogurt containing 10^9 CFU Akkermansia muciniphila 30 min befor meal daily for 8 weeks
Intervention group2: 22 participants will consume 120cc of yogurt containing 10^9CFU Lactobacillus acidophilus 30 min befor meal daily for 8 weeks
Control group:22 participants will consume 120 cc of low fat yogurt 30 min befor meal daily for 8 weeks
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
Intervention group1:22 participants will consume 120cc of yogurt containing 10^9 CFU10 TFU Akkermansia muciniphila 30 minpostbiotic 30min befor meal daily for 8 weeks Intervention group2: 22 participants will consume 120cc of yogurt containing 10^9CFU10TFU Lactobacillus acidophilus 30 minrhamnosus postbiotic 30min befor meal daily for 8 weeks8weeks Control group:22 participants will consume 120 cc120cc of low fat yogurt 30 min30min befor meal daily for 8 weeks8weeks
گروه مداخله1: 22 نفر از شرکت کنندگان 120 سی سی ماست حاوی 9^10 CFU پروبیوتیک آکرمانسیا موسینیفیلا روزانه نیم ساعت قبل از غذا به مدت 8 هفته مصرف خواهند کرد.
گروه مداخله 2: 22 نفر از شرکت کنندگان 120 سی سی ماست حاوی 9^10 CFU پروبیوتیک لاکتوباسیلوس اسیدوفیلوس روزانه نیم ساعت قبل از غذا به مدت 8 هفته مصرف خواهند کرد.
گروه کنترل: 22 نفر از شرکت کنندگان 120 سی سی ماست کم چرب (1/4%) روزانه نیم ساعت قبل از غذا به مدت 8 هفته مصرف خواهند کرد.
گروه مداخله1: 22 نفر از شرکت کنندگان 120 سی سی ماست حاوی 10^10 TFU پست بیوتیک آکرمانسیا موسینیفیلا روزانه نیم ساعت قبل از غذا به مدت 8 هفته مصرف خواهند کرد.
گروه مداخله 2: 22 نفر از شرکت کنندگان 120 سی سی ماست حاوی 10^10 TFU پست بیوتیک لاکتوباسیلوس رامنوسوس روزانه نیم ساعت قبل از غذا به مدت 8 هفته مصرف خواهند کرد.
گروه کنترل: 22 نفر از شرکت کنندگان 120 سی سی ماست کم چرب (1/4%) روزانه نیم ساعت قبل از غذا به مدت 8 هفته مصرف خواهند کرد.
گروه مداخله1: 22 نفر از شرکت کنندگان 120 سی سی ماست حاوی 910^10 CFU پروبیوتیکTFU پست بیوتیک آکرمانسیا موسینیفیلا روزانه نیم ساعت قبل از غذا به مدت 8 هفته مصرف خواهند کرد. گروه مداخله 2: 22 نفر از شرکت کنندگان 120 سی سی ماست حاوی 910^10 CFU پروبیوتیکTFU پست بیوتیک لاکتوباسیلوس اسیدوفیلوسرامنوسوس روزانه نیم ساعت قبل از غذا به مدت 8 هفته مصرف خواهند کرد. گروه کنترل: 22 نفر از شرکت کنندگان 120 سی سی ماست کم چرب (1/4%) روزانه نیم ساعت قبل از غذا به مدت 8 هفته مصرف خواهند کرد.
General information
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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.
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.
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به دلیل عدم دسترسی به پروبیوتیک لاکتوباسیلوس اسیدوفیلوس به عنوان یکی از مداخلات مطالعه، لاکتوباسیلوس رامنوسوس جایگزین می شود و با توجه به اینکه اثرات پست بیوتیک آکرمانسیا موسینیفیلا نسبت به پروبیوتیک آن ایمن تر و بیشتر بوده، لذا تصمیم گرفتیم که از پست بیوتیک آن در این مطالعه استفاده کنیم.
به دلیل عدم دسترسی به پروبیوتیک لاکتوباسیلوس اسیدوفیلوس به عنوان یکی از مداخلات مطالعه، لاکتوباسیلوس رامنوسوس جایگزین می شود و با توجه به اینکه اثرات پست بیوتیک آکرمانسیا موسینیفیلا نسبت به پروبیوتیک آن ایمن تر و بیشتر بوده، لذا تصمیم گرفتیم که از پست بیوتیک آن در این مطالعه استفاده کنیم.
Comparing the effects of yogurt containing Akkermansia Muciniphilia with yogurt containing Lactobacillus Acidophilus on body composition, anthropometric and biochemical indices, appetite, and depression scores in overweight or obese adults
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
Comparing the effects of yogurt containing Akkermansia Muciniphilia postbiotic with yogurt containing Lactobacillus AcidophilusRhamnosus postbiotic on body composition, anthropometric and biochemical indices, appetite, and depression scores in overweight or obese adults
مقایسه تاثیر مصرف ماست حاوی آکرمانسیا موسینیفیلا با ماست حاوی لاکتوباسیلوس اسیدوفیلوس بر ترکیب بدن، شاخص های تن سنجی و بیوشیمیایی، نمره اشتها و افسردگی در افراد بزرگسال دارای اضافه وزن یا چاقی
مقایسه تاثیر مصرف ماست حاوی پست بیوتیک آکرمانسیا موسینیفیلا با ماست حاوی پست بیوتیک لاکتوباسیلوس رامنوسوس بر شاخص های تن سنجی و بیوشیمیایی، نمره اشتها و افسردگی در افراد دارای اضافه وزن و چاقی
مقایسه تاثیر مصرف ماست حاوی پست بیوتیک آکرمانسیا موسینیفیلا با ماست حاوی پست بیوتیک لاکتوباسیلوس اسیدوفیلوسرامنوسوس بر ترکیب بدن، شاخص های تن سنجی و بیوشیمیایی، نمره اشتها و افسردگی در افراد بزرگسال دارای اضافه وزن یاو چاقی
Comparing the effects of yogurt containing Akkermansia Muciniphilia with yogurt containing Lactobacillus Acidophilus on body composition, anthropometric and biochemical indices, appetite, and depression scores in overweight or obese adults: a Randomized, double-blind, controlled clinical trial
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
Comparing the effects of yogurt containing Akkermansia Muciniphilia postbiotic with yogurt containing Lactobacillus AcidophilusRhamnosus postbiotic on body composition, anthropometric and biochemical indices, appetite, and depression scores in overweight or obese adults: a Randomized, double-blind, controlled clinical trial
مقایسه تاثیر مصرف ماست حاوی آکرمانسیا موسینیفیلا با ماست حاوی لاکتوباسیلوس اسیدوفیلوس بر ترکیب بدن، شاخص های تن سنجی و بیوشیمیایی، نمره اشتها و افسردگی در افراد بزرگسال دارای اضافه وزن یا چاقی: یک مطالعه کارآزمایی بالینی تصادفی، کنترل شده دوسوکور
مقایسه تاثیر مصرف ماست حاوی پست بیوتیک آکرمانسیا موسینیفیلا با ماست حاوی پست بیوتیک لاکتوباسیلوس رامنوسوس بر شاخص های تن سنجی و بیوشیمیایی، نمره اشتها و افسردگی در افراد دارای اضافه وزن و چاقی: یک مطالعه کارآزمایی بالینی تصادفی، کنترل شده دوسوکور
مقایسه تاثیر مصرف ماست حاوی پست بیوتیک آکرمانسیا موسینیفیلا با ماست حاوی پست بیوتیک لاکتوباسیلوس اسیدوفیلوسرامنوسوس بر ترکیب بدن، شاخص های تن سنجی و بیوشیمیایی، نمره اشتها و افسردگی در افراد بزرگسال دارای اضافه وزن یاو چاقی: یک مطالعه کارآزمایی بالینی تصادفی، کنترل شده دوسوکور
Intervention groups
#1
Intervention group 1: consume 120 cc of yogurt containing 10^9 CFU Ackermansia muciniphila befor meal daily for 8 weeks.
Intervention group 1: consume 120 cc of yogurt containing 10^10 TFU Ackermansia muciniphila postbiotic befor meal daily for 8 weeks.
Intervention group 1: consume 120 cc of yogurt containing 10^9 CFU10 TFU Ackermansia muciniphila postbiotic befor meal daily for 8 weeks.
گروه مداخله اول: روزانه به مدت 8 هفته 120 سی سی ماست حاوی 9^10 CFU پروبیوتیک آکرمانسیا موسینیفیلا قبل از غذا دریافت می کنند.
گروه مداخله اول: روزانه به مدت 8 هفته 120 سی سی ماست حاوی 10^10 TFU پست بیوتیک آکرمانسیا موسینیفیلا قبل از غذا دریافت می کنند.
گروه مداخله اول: روزانه به مدت 8 هفته 120 سی سی ماست حاوی 910^10 CFU پروبیوتیکTFU پست بیوتیک آکرمانسیا موسینیفیلا قبل از غذا دریافت می کنند.
#2
Intervention group 2: consume 120 cc of yogurt containing 10^9 CFU Lactobacillus Acidophilus befor meal daily for 8 weeks.
Intervention group 2: consume 120 cc of yogurt containing 10^10 TFU Lactobacillus Rhamnosus postbiotic befor meal daily for 8 weeks.
Intervention group 2: consume 120 cc of yogurt containing 10^9 CFU10 TFU Lactobacillus AcidophilusRhamnosus postbiotic befor meal daily for 8 weeks.
گروه مداخله دوم: روزانه به مدت 8 هفته 120 سی سی ماست حاوی 9^10 CFU پروبیوتیک لاکتوباسیلوس اسیدوفیلوس قبل از غذا دریافت می کنند.
گروه مداخله دوم: روزانه به مدت 8 هفته 120 سی سی ماست حاوی 10^10 TFU پست بیوتیک لاکتوباسیلوس رامنوسوس قبل از غذا دریافت می کنند.
گروه مداخله دوم: روزانه به مدت 8 هفته 120 سی سی ماست حاوی 910^10 CFU پروبیوتیکTFU پست بیوتیک لاکتوباسیلوس اسیدوفیلوسرامنوسوس قبل از غذا دریافت می کنند.
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
Sponsors / Funding sources
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