To evaluate the efficacy and side effects of using the Ma-al-Jobn (whey protein) in treatment of diabetic patients as a complementary therapy
Design
Randomized controlled clinical trial with parallel groups and double blinded
Settings and conduct
This study is conducting in Fasa and participants and researchers are blinded to the study groups.
Participants/Inclusion and exclusion criteria
All the diabetic patients with HgbA1c more than 6.4 who are between 30 to 65 years old and have a weight less than 100 kg will recruit in this study. Additional inclusion criteria are; not to have any alcohol or drug addiction, have a BMI less than 35 and not to consume any corticosteroid and herbal or chemical anti-diabetic drug.
Intervention groups
Participants consume a sachet per day for 3 months besides their anti-diabetic drugs. They open a sachet in a glass of hot water (150-200 cc) and drink it before breakfast. In drug group each sachet contains whey protein and in control group each sachet has caramelized corn flour.
Main outcome variables
FBS; BS2pp; HgbA1c; Cholestrol; HDL; LDL; TG and LFT
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140715018490N4
Registration date:2018-07-20, 1397/04/29
Registration timing:prospective
Last update:2018-07-20, 1397/04/29
Update count:0
Registration date
2018-07-20, 1397/04/29
Registrant information
Name
Massih Sedigh Rahimabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3825 6275
Email address
sedighrm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
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
To evaluate the efficacy and side effects of using the Ma-al-Jobn in treatment of diabetic type II patients as a complementary therapy
Public title
To evaluate the complementary effect of whey protein for treatment of diabetes type II
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of diabetes (FBS>126 mg/dl)
Have a FBS less than 250 and HgbA1c more than 6.4
Age between 30 to 65 years
No systemic diseases like; liver, renal, rheumatologic diseases or hypertension
No consume any anti-diabetic or corticosteroid drugs 2 weeks before the study
No drink alcohol or use opium
Weight less than 100 kg
Have a BMI less than 35
Exclusion criteria:
No agree to participate in the study
Have a FBS more than 270 mg/dl
Consuming corticosteroid drugs during the study
Presence of any side effects
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked Randomized Table
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and researchers are blinded to the study groups. Placebo and therapeutic sachets are similar to each other and labeled by a letter (A to D).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Comimtte of Fasa University of Medical Sciences
Street address
Ebn-Sina square
City
Fasa
Province
Fars
Postal code
86688-74616
Approval date
2018-03-13, 1396/12/22
Ethics committee reference number
IR.FUMS.REC.1396.313
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
FBS
Timepoint
At the beginning of intervention, after 2 weeks then after 12 weeks from the beginning of intervention
Method of measurement
Venous blood sampling
2
Description
HgbA1C
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention
Method of measurement
Venous blood sampling
3
Description
Total cholesterol
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention
Method of measurement
Venous blood sampling
4
Description
BS2pp
Timepoint
At the beginning of intervention, after 2 weeks then after 12 weeks from the beginning of intervention
Method of measurement
Venous blood sampling
5
Description
LDL
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention
Method of measurement
Venous blood sampling
6
Description
HDL
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention
Method of measurement
Venous blood sampling
7
Description
SGOT
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention
Method of measurement
Venous blood sampling
8
Description
SGPT
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention
Method of measurement
Venous blood sampling
9
Description
Alp
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention
Method of measurement
Venous blood sampling
10
Description
TG
Timepoint
At the beginning of intervention and after 12 weeks from the beginning of intervention
Method of measurement
Venous blood sampling
Secondary outcomes
1
Description
Satisfaction of patients
Timepoint
3 months after recruitment
Method of measurement
visual analog scale
2
Description
Tolerance
Timepoint
3 months after recruitment
Method of measurement
visual analog scale
3
Description
Temperament
Timepoint
At the beginning of the study
Method of measurement
Questionnaire
4
Description
Drug side effects
Timepoint
3 months after recruitment
Method of measurement
Questionnaire
Intervention groups
1
Description
Drug group: In addition to anti-diabetes medications, patients in this group should receive a sachet of whey protein powder (12.5 g. each) in 150-200 cc of hot water every day. They are asked to drink it before breakfast and not to eat or drink until 1 hour after consumption.
Category
Treatment - Drugs
2
Description
Control group: In addition to anti-diabetes medications, patients in this group should receive a sachet of caramelized corn powder (5 g. each) in 150-200 cc of hot water every day. They are asked to drink it before breakfast and not to eat or drink until 1 hour after consumption.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic
Full name of responsible person
Sahar Sajadi
Street address
Taleghani st.
City
Fasa
Province
Fars
Postal code
12
Phone
+98 71 5331 4076
Email
massih21@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Farjam
Street address
Fasa University of Medical Sciences, Ebnesina square, Fasa
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Email
pajohan@fums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Massih Sedigh Rahimabadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Ghazal II, Paeez st., Pasargad Ave.
City
Shiraz
Province
Fars
Postal code
123456789
Phone
+98 71 3825 6275
Email
massih21@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Massih Sedigh Rahimabadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Ghazal II, Paeez st., Pasargad Ave.
City
Shiraz
Province
Fars
Postal code
123456789
Phone
+98 71 3825 6275
Email
massih21@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Sahar Sajadi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Fasa university of medical sciences, Ibn-e-Sina Sq.
City
Fasa
Province
Fars
Postal code
74616-86688
Phone
+98 71 5331 4076
Email
saharsajjadi1396@gmail.com
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
Data and results of analysis will be published in a paper.
When the data will become available and for how long
After the end of study.
To whom data/document is available
All of those who have access to the article.
Under which criteria data/document could be used
The editor in chief, if necessary.
From where data/document is obtainable
Vice chancellor for research affair of Fasa University of Medical Sciences
What processes are involved for a request to access data/document
Asking from Vice chancellor for research affair of Fasa University of Medical Sciences