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The effect of sour tea consumption (Hibiscus sabdariffa L.) on the lipid profile in dyslipidemic subjects

Protocol summary

Summary
In this randomized clinical trial, inclusion criteria are: having polygenic dyslipidemia as defined, not taking lipid lowering drugs and exclusion criteria are: having allergy to tea, not interested in consuming tea; having other diseases such as familial dyslipidemia, diabetes, cardiovascular disease, kidney and liver diseases. 50 patients after signing informed consent will be entered to the study. The patients will be randomly assigned into two intervention and control groups. Both groups at baseline will receive lifestyle modification education. The intervention period will be 12 weeks, in which the intervention group will consume two cups of sour tea extract daily between morning and evening meals for 90 days (each time, add two teaspoons (2 grams) of pulverized sour tea in one glass of boiling water (240 ml) for 30 minutes, with a sugar cube (3 g)). The Intervention group will be assessed and followed of possible complications of consuming sour tea. In both groups total cholesterol, triglyceride, LDL-c, HDL-c will be measured at baseline, and six weeks and twelve weeks after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201008224612N1
Registration date: 2012-04-30, 1391/02/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-04-30, 1391/02/11
Registrant information
Name
Farihe Ahmadzadeh Sani
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 3722 1929
Email address
farihe_ahmadzadeh1384@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
The International Branch of Shahid Beheshti University of Medical Sciences & Health Services
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-09-20, 1391/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sour tea consumption (Hibiscus sabdariffa L.) on the lipid profile in dyslipidemic subjects
Public title
The effect of sour tea (Hibiscus sabdariffa L.) on the lipid
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Polygenic dyslipidemia as defined; not intaking lipid lowering drugs Exclusion criteria: allergy to tea; not interested in consuming tea; take a trip; having other diseases such as familial dyslipidemia; diabetes; cardiovascular disease; kidney and liver diseases
Age
From 30 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Ethics Committee of the International Branch of Shahid Beheshti University of Medical Scien
Street address
19 Shahid Abbaspour St., Vali-Asr Ave., the International Branch of Shahid Beheshti University of Medical Sciences & Health Services
City
Tehran
Postal code
141553693
Approval date
2012-01-01, 1390/10/11
Ethics committee reference number
116/5237

Health conditions studied

1

Description of health condition studied
polygenic Dyslipidemia
ICD-10 code
E78.2
ICD-10 code description
Mixed hyperlipidaemia

Primary outcomes

1

Description
total cholesterol
Timepoint
Baseline, six weeks and twelve weeks after intervention
Method of measurement
Cholesterol oxidase enzymatic method

Secondary outcomes

1

Description
LDL-C
Timepoint
Baseline, six weeks and twelve weeks after intervention
Method of measurement
Fridvald is calculated using the formula

2

Description
HDL-c
Timepoint
Baseline, six weeks and twelve weeks after intervention
Method of measurement
Cholesterol oxidase enzymatic method

3

Description
triglyceride
Timepoint
Baseline, six weeks and twelve weeks after intervention
Method of measurement
Glycerol oxidase enzymatic methods

Intervention groups

1

Description
Intervention group: The Intervention group will receive lifestyle modification education at baseline and then consume two cups of sour tea extract daily between morning and evening meals for 90 days (each time, add two teaspoons (2 grams) of pulverized sour tea in one glass of boiling water (240 ml) for 30 minutes, and take it with a sugar cube (3 grams)).
Category
Treatment - Other

2

Description
Control group: The Control group will receive lifestyle modification education at baseline only and do not consume sour tea.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Gonabad,s 22 Bahman Hospital
Full name of responsible person
Farihe Ahmadzadeh Sani
Street address
Gonabad University of Medical Sciences, Food and Drug Administration, Ghadir Square
City
Gonabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
the International Branch of Shahid Beheshti University of Medical Sciences & Health Services
Full name of responsible person
Dr.Kiandokht Ghanati
Street address
19 Shahid Abbaspour St., Vali-Asr Ave., the International Branch of Shahid Beheshti University of Medical Sciences & Health Services
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
the International Branch of Shahid Beheshti University of Medical Sciences & Health Services
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
Name of organization / entity
the International Branch of Shahid Beheshti University of Medical Sciences & Health Services
Full name of responsible person
Farihe Ahmadzadeh Sani
Position
MSc.student in nutrition sciences
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Food and Drug Administration, Ghadir Square
City
Gonabad
Postal code
9691699967
Phone
+98 53 3722 1929
Fax
+98 53 3722 1919
Email
farihe_ahmadzadeh1384@gmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
the International Branch of Shahid Beheshti University of Medical Sciences & Health Services
Full name of responsible person
Farihe Ahmadzadeh Sani
Position
MSc.student in nutrition sciences
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Food and Drug Administration, Ghadir Square
City
Gonabad
Postal code
9691699967
Phone
+98 53 3722 1929
Fax
+98 53 3722 1919
Email
farihe_ahmadzadeh1384@gmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
the International Branch of Shahid Beheshti University of Medical Sciences & Health Services
Full name of responsible person
Farihe Ahmadzadeh Sani
Position
MSc.student in nutrition sciences
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Food and Drug Administration, Ghadir Square
City
Gonabad
Postal code
9691699967
Phone
+98 53 3722 1929
Fax
+98 53 3722 1919
Email
farihe_ahmadzadeh1384@gmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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