The effects of symbiotic supplement containing Bacillus coagulans and fructo oligosaccharide on glycemic index , cardiovascular risk factors and and systemic inflammation in patients with type 2 diabetes
The effects of symbiotic supplementation of bacillus coagulans and fructo oligosaccharide on glucose metabolism,insulin concentration,insulin resistance,lipid profiles and systemic inflammation in type 2 diabetic patients
Design
The present study will be conducted as a phase 3, randomized double-blind placebo controlled trial on 40 type 2diabetics patients allocated in 2 parallel groups each consisted of 20 patients who will receive symbiotic or placebo.From the beginning of the study, A and B codes are available to researchers to recruit the patients using simple Randomization.
Settings and conduct
The study will perform at Imam Hossein Hospital. Information on demographic data and 24 hours recall will be collected.Patients will be blinded about the intervention type and will randomized to either the placebo or intervention group at the beginning of study for 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria
The willingness to participant
• Age from 30 to 70 years
• Body mass index ≤ 35 kg / m2
• Having type 2 diabetes
• Pregnancy and lactation
• Not getting thyroid gland disorders
• Lack of kidney and inflammatory disease
• Lack of weight loss regimens 6 months before the start of the study
• No use of glucocorticoids and non-steroidal anti-inflammatory drugs
• Do not use of insulin
Exclision criteria
• Complications associated with supplementation
• Not using regular supplement
• Consume less than 80% of supplements in three months
Intervention groups
Patients in the intervention group will receive 1sachet containing symbiotic
in addition to routine medications. While the control group will receive 1 placebo sachet which will be indistinguishable from symbiotic sachetes in taste and appearance.
Main outcome variables
Fasting blood surge;Triglyceride;Low-density lipoprotein;High-density lipoprotein;Insulin level; High sensitive C reactive protein level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190103042220N1
Registration date:2019-01-07, 1397/10/17
Registration timing:registered_while_recruiting
Last update:2019-01-07, 1397/10/17
Update count:0
Registration date
2019-01-07, 1397/10/17
Registrant information
Name
aynaz velayaty
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 7483
Email address
avelayaty@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-05, 1397/03/15
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of symbiotic supplement containing Bacillus coagulans and fructo oligosaccharide on glycemic index , cardiovascular risk factors and and systemic inflammation in patients with type 2 diabetes
Public title
The effects of symbiotic supplement on complications of type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to cooperate and complete informed informed consent form • Patients aged 30-70 years • Body mass index ≤ 35 kg / m2 • haveType 2 diabetes • No history of alcohol or alcohol less than 10 grams Per day in women and less than 20 grams per day in men • no pregnancy and lactation • no thyroid gland disorders • no kidney and inflammatory disease • failure to follow weight loss regimens 6 months before the start of the study • no use Slimming drugs (Orlites, Slim Lists) and fat burners, fiber powder • Non-use of glucocorticoids and non-steroidal anti-inflammatory drugs • no use of insulin
Exclusion criteria:
•show complications associated with supplementation• No regular use of supplement• Consume less than 80% of supplements in three months
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
in this study simple randomization will used for sample selection with using table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
in this study participants and researchers will not aware of the type of assigned innervation for each patients. Symbiotic or placebo are marked by A or B codes and patients will receive one of them randomly.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
No. 7, Hafezi Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2018-10-20, 1397/07/28
Ethics committee reference number
IR.SBMU.nnftri.Rec.1397.230
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11.9
ICD-10 code description
Type 2 diabetes mellitus without complications
Primary outcomes
1
Description
Changes in fasting blood sugare
Timepoint
At the baseline of intervention and at the end of study.
Method of measurement
Enzymatic methods using kit
2
Description
Triglyceird level
Timepoint
At the baseline of intervention and at the end of study.
Method of measurement
Enzymatic methods using kit
3
Description
Low-density lipoprotein
Timepoint
At the baseline of intervention and at the end of study.
Method of measurement
Enzymatic methods using kit
4
Description
High-density lipoprotein
Timepoint
At the baseline of intervention and at the end of study.
Method of measurement
Enzymatic methods using kit
5
Description
Serum insulin level
Timepoint
At the baseline of intervention and at the end of study.
Method of measurement
Enzymatic methods using kit
6
Description
High-sensitive C-reactive protein
Timepoint
At the baseline of intervention and at the end of study.
Method of measurement
Enzymatic methods using kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group will receive 1 sachets contains symbiotic every day for 12 weeks
Category
Treatment - Other
2
Description
Control group: Control group will receive 1 placebo every day for 12 weeks