Protocol summary

Study aim
Determining the effect of consuming aloe vera food powder on fasting blood sugar, lipid profile, body indicators measurement, combination of body mass and blood pressure of patients with type 2 diabetes
Design
Clinical trial with control group, with parallel, double-blind, randomized groups
Settings and conduct
In this randomized clinical trial, double blind study 60 individuals with type 2 diabetes participated. After obtaining the consent of the eligible people to participate in the study, at the beginning and end of the study, after 11 hours of fasting at night, blood samples were collected and demographic information, body measurement and food intake were obtained. The participants were randomly assigned to two intervention groups (aloe vera) and placebo for 8 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) The desire to participate in the study 2) Age range 18 to 69 years 3) Diagnosis of type 2 diabetes by a specialist 4) Duration of type 2 diabetes, at least 6 months 5) Having stable weight over the past 6 months( Self-report) 6) The type and dose of drugs used to be stable in the last 6 months Exclusion criteria 1) No Allergy to aloe vera or products containing it 2) No pregnancy and breastfeeding 9) No using any food supplement in the last 6 months 3) No smoking and being addicted 4) NO acute heart disease, stroke, liver, kidney, gastrointestinal, thyroid and parathyroid, rheumatoid and infectious arthritis
Intervention groups
One group was given an oral aloe vera powder and the other group was given an oral tost flour
Main outcome variables
The oral effects of aloe vera on fasting glucose, triglycerides and weight, body mass index, abdominal circumference and systolic blood pressure were investigated in people with type 2 diabetes.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200331046900N1
Registration date: 2020-06-24, 1399/04/04
Registration timing: retrospective

Last update: 2020-06-24, 1399/04/04
Update count: 0
Registration date
2020-06-24, 1399/04/04
Registrant information
Name
Najmeh sadat Zareayan jahromi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 9101 1710
Email address
najmeh.zareayan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
2019-02-24, 1397/12/05
Actual recruitment end date
2019-03-03, 1397/12/12
Trial completion date
2019-06-09, 1398/03/19
Scientific title
Evaluation the Effect of Oral Aloe Vera Administration on Fasting Plasma Glucose, Lipid Profile, Body Composition Components, Anthropometric Indices, and Blood Pressure Values in Patients with Diabetes Type 2
Public title
Effect of oral aloe vera powder on type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the study Age range 18 to 69 years Diagnosis of type 2 diabetes by a specialist The minimum duration of type 2 diabetes is 6 months Weight constant over the past 6 months ( Self-report ) The type and dose of medications taken have been stable over the past 6 months
Exclusion criteria:
Allergy to aloe vera or products containing it Pregnancy and lactation Use of any dietary supplement in the last 6 months Smoking and addiction Acute heart disease, stroke, liver, kidney, gastrointestinal, thyroid and parathyroid disease, rheumatoid and infectious arthritis
Age
From 18 years old to 69 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 60
More than 1 sample in each individual
Number of samples in each individual: 2
Before the intervention and after the intervention
Actual sample size reached: 60
More than 1 sample in each individual
Actual sample size in each individual: 2
Before the intervention and after the intervention
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation of participants in two groups of intervention and control is done by the Balanced block randomization method. (Randomization of people between the two groups will be done by blocking method. Thus, the size of the blocks is considered to be 4 and all possible cases are written for groups A and B, and this will be done until the number reaches 60 people.) It is repeated. Then, using a table of random numbers, each of the components of the blocks is given a number. The numbers given to each of the components of the blocks represent the number intended for each person that has already been determined. So the order of the group assigned to each person is specified).
Blinding (investigator's opinion)
Double blinded
Blinding description
Study participants, researchers, and assistants did not know who was in the intervention group and who was in the placebo group. The person who checked the information did not know which group the person belonged to, and the person who delivered the drugs did not know which group was interfering and knew groups 1 and 2. In addition, for weekly follow-ups, the first person was in contact with people who did not know in which group the person was. Participants did not know from the beginning to the end of study which group they were in.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2019-03-06, 1397/12/15
Ethics committee reference number
IR.SUMS.REC.1398.210

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
Total cholesterol
Timepoint
Before the intervention and after the intervention
Method of measurement
Blood test

Secondary outcomes

1

Description
Fasting blood sugar
Timepoint
Before and after the intervention
Method of measurement
Blood test

2

Description
Triglyceride
Timepoint
Before and after the intervention
Method of measurement
Blood test

3

Description
High-density lipoprotein
Timepoint
Before and after the intervention
Method of measurement
Blood test

4

Description
Low-density lipoprotein
Timepoint
Before and after the intervention
Method of measurement
Blood test

5

Description
Anthropometry
Timepoint
Before and after the intervention
Method of measurement
Scales, meters, calipers and ...

6

Description
Blood pressure
Timepoint
Before and after the intervention
Method of measurement
Blood pressure monitor

Intervention groups

1

Description
Intervention group: The raw materials and raw materials required were purchased from Shiraz University of Medical Sciences School of Pharmacy with the advice and approval of a consultant, and then combined under standard conditions and intervened as a supplement. Finally, the capsule contained the main intervention containing 500 mg of aloe vera of the species Barbadensis Aloe prepared by Adonis Gol Daru Company (which was placed in a capsule and patients were advised to take 2 tablets daily for 56 days ( 1 after breakfast and 1 after dinner).
Category
Treatment - Drugs

2

Description
Control group: 500 mg test powder with the advice and approval of a consultant from Shiraz University of Medical Sciences School of Pharmacy in a capsule that was exactly the same in terms of shape, color, smell and size with the capsule containing the main intervention and as a placebo to participants. It is recommended to take 2 tablets daily for 56 days (1 after breakfast and 1 after dinner).
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Qutbuddin Hospital
Full name of responsible person
Mehdi Ayaz
Street address
Fakhrabad
City
Shiraz
Province
Fars
Postal code
7163854733
Phone
+98 71 3821 9638
Email
ghot_be_din2005@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mehrzad Lotfi
Street address
Karim Khan Zand
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
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
Najmeh Sadat Zareian Jahromi
Position
Master of Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Karim Khan Zand
City
Shiraz
Province
Fars
Postal code
7135848648
Phone
+98 71 9101 1710
Email
najmeh.zareayan@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Siavash Baba Jafari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Zahra Alley
City
Shiraz
Province
Fars
Postal code
۷۱۵۳۶۷۵۵۴۱
Phone
+98 71 3725 1001
Email
jafaris@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Siavash Baba Jafari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Zahra Alley
City
Shiraz
Province
Fars
Postal code
۷۱۵۳۶۷۵۵۴۱
Phone
+98 71 3725 1001
Email
jafaris@sums.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The Excel file contains all the data
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Data will only be available to researchers working at academic and scientific institutions
Under which criteria data/document could be used
Get permission before using the project executor
From where data/document is obtainable
Dr. Siavash Baba Jafari: jafaris@sums.ac.ir Najmeh Sadat Zareian Jahromi: najmeh.zareayan@gmail.com
What processes are involved for a request to access data/document
The applicant will introduce himself in an email and explain the reason for the need for data.   After review, the data will be sent within a week if agreed.
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