Objectives: The purpose of this study is to investigate the effect of Tamarindus indica L. fruit for 6 weeks, on body weight, BMI, serum lipid profile, blood pressure and blood sugar levels in obese and overweight adult patients.
Design:
This study will be conducted as a randomized blinded controlled trial, with the election of 44 overweight or obese volunteers with mild to moderate initial BMI (25 to 39.9) and age over 18 years.
Setting and conduct:
44 volunteers will be randomly assigned (by random number table method) into two equal intervention and control groups.
Inclusion criteria: in obese and overweight adult patients (BMI over 25 and less 39.9); subjects aged over 18 years. Exclusion criteria: Individuals with a history of any diseases; diabetes; cardiovascular disease; liver and kidney as well as pregnant and breastfeeding; Drugs of increasing body weight, body weight loss drugs will be excluded.
Intervention group: Participants of the case group will be asked to not only follow the prescribed diet but also will be consumed Tamarindus indica L. Fruit , 10 grams, twice a day with meals for 6 weeks.
Participants of the control group will be asked to follow the suitable diet.
Main outcome measures: body weight, BMI, serum lipid profile, blood pressure and blood sugar levels.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608259662N11
Registration date:2017-01-15, 1395/10/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-15, 1395/10/26
Registrant information
Name
Sedigheh Asgary
Name of organization / entity
Isfahan Cardiovascular Research Center ,Isfahan Cardiovascular Research institute , Physiology Re
Country
Iran (Islamic Republic of)
Phone
+98 31 1335 9090
Email address
s_asgari@crc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Isfahan University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effects of Tamarindus indica L. fruit on body weight, serum lipid profile, and blood pressure among obese and overweight adults
Public title
The effects of Tamarindus indica L. fruit on overweight and besity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: obese and overweight adults (BMI over 25 and less 39.9); subjects aged over 18 years.
Exclusion criteria: Individuals with a history of diabetes, cardiovascular disease, liver and kidney as well as pregnancy and breastfeeding; Drugs which increase or body weight or are used to lose weight (orlistat, phentermine, diethylpropion, topiramate, bupropion, metformin, SSRI drugs and herbal medicines on the market) from 2 months before the start of the study; Drugs affecting blood lipid levels include statins, fibrates, sex hormones (estrogen, progestins and birth control pills), beta-blockers, alpha-blocker, corticosteroids, isotretinoin, cyclosporine) from 2 months prior to the study and supplements like fish oil which is effect on blood lipids levels
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jirib St. Isfahan, Iran
City
Isfahan
Postal code
Approval date
2014-06-01, 1393/03/11
Ethics committee reference number
92124
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66.8
ICD-10 code description
Morbid obesity
Primary outcomes
1
Description
BMI
Timepoint
Before and after 6 weeks
Method of measurement
Meters and weight scales
2
Description
total cholestrol
Timepoint
Before and after 6 weeks
Method of measurement
Parss Azmon KIT/Hitachi Device
3
Description
HDL
Timepoint
Before and after 6 weeks
Method of measurement
Parss Azmon KIT / Hitachi Device
4
Description
LDL
Timepoint
Before and after 6 weeks
Method of measurement
Parss Azmon KIT/Hitachi Device
5
Description
TG
Timepoint
Before and after 6 weeks
Method of measurement
Parss Azmon KIT/Hitachi Device
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before and after 6 weeks
Method of measurement
Sphygmomanometer
Intervention groups
1
Description
Intervention group: Participants of the case group will be asked not only to follow the prescribed diet but also to consume Tamarindus indica L. Fruit pulp (Available in the Market), 10 grams, twice a day with meals for 6 weeks.
Category
Treatment - Drugs
2
Description
Control group: the second group will be asked to use suitable and usual diet for 6 weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Cardiovascular Research Center
Full name of responsible person
Dr. Rasool Soltani
Street address
Khorram Sstreet, Jomhori square
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Dr.Gholam Hossin Sadri
Street address
Hezar jirib St.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Cardiovascular Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Sedigheh Asgary
Position
Pharmacist and PhD Pharmacogenetics
Other areas of specialty/work
Street address
Khorram Street, Jomhoori Square
City
Isfahan
Postal code
Phone
+98 313359090
Fax
Email
sasgary@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Pharmacist
Other areas of specialty/work
Street address
Hezar Jerib Ave., Azadi sqr.
City
Isfahan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)