Objective: The aim of this study is to determine the effect of oral soft gel containing lemon essential oil and Xenical capsule on weight in subjects with BMI≥25. Study design: parallel double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Subjects aged 18-50 years with overweight and obesity (BMI≥25) will be included in this study. Individuals with neoplastic, cardiovascular disorders, malabsorptive disorders, current or previous (within the last 6 months) use of hormonal and anti-obesity medications will be excluded in the study. Population and sample size: 105 subjects with overweight and obese eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Subjects will be assigned to receive either oral soft gel containing lemon essential oil (intervention group: n=35), Xenical capsule (intervention group: n=35) or placebo (control group: n=35). Subjects' weight will be recorded in baseline and end-of-trial. Fasting blood samples will be taken at baseline and after 8-wk intervention to measure metabolic profiles and thyroid hormones. Start and End Date of Intervention: 8 weeks (July 11, 2013-September 11, 2013). Outcomes: Weight, fasting plasma glucose (FPG), serum insulin, lipid profiles and thyroid hormones will be measured in baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306225623N9
Registration date:2013-06-30, 1392/04/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-06-30, 1392/04/09
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij Essence Medicinal Plants Research Center
Expected recruitment start date
2013-07-11, 1392/04/20
Expected recruitment end date
2013-09-11, 1392/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral soft gel containing lemon essential oil and Xenical capsule on weight in subjects with overweight and obesity
Public title
Effect of oral soft gel containing lemon essential oil and Xenical capsule in treatment of obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Subjects aged 18-50 years; BMI≥25.
Exclusion Criteria: Individuals with neoplastic; cardiovascular disorders; malabsorptive disorders; current or previous (within the last 6 months) use of hormonal; anti-obesity medications.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Postal code
Approval date
2013-03-13, 1391/12/23
Ethics committee reference number
P/29/5/1/4640
Health conditions studied
1
Description of health condition studied
Overweight and Obesity
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified
Primary outcomes
1
Description
Weight
Timepoint
Baseline and End-of-trial
Method of measurement
Scale
2
Description
Fasting plasma glucose
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
3
Description
Insulin
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
4
Description
T3
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
5
Description
T4
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
6
Description
TSH
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Oral soft gel containing lemon essential oil, 100 mg, three times a day, for 8 weeks orally.
Category
Treatment - Drugs
2
Description
Intervention group: Xenical capsule, 120 mg, three times a day, for 8 weeks orally.
Category
Treatment - Drugs
3
Description
Control group: Placebo capsule, three times a day, for 8 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Barij Essence Company
Full name of responsible person
Mohsen Taghizadeh
Street address
Barij Essence Company, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Essence Company
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
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutrition PhD
Other areas of specialty/work
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Postal code
Phone
+98 36 1446 3378
Fax
Email
asemi_z@kaums.ac.irasemi_r@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutrition PhD
Other areas of specialty/work
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Postal code
Phone
+98 36 1446 3378
Fax
Email
asemi_z@kaums.ac.irasemi_r@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)