Protocol summary
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Study aim
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The aim of this study is to determine the effect of oral soft gel containing lemon and cumin essential oil in various doses on weight in subjects with BMI≥25.
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Design
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Parallel double-blind randomized controlled clinical trial.
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Settings and conduct
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72 subjects with overweight and obese eligible and referred to Naghavi Diet Therapy Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Subjects aged 18 - 50 years with overweight or obesity (BMI ≥ 25 kg/m2). The exclusion criteria will as follows: BMI < 25 kg/m2, subjects with hypertension, thyroid, diabetes or cardiovascular disorders, pregnancy and lactation and the use of hormonal or anti-obesity medications.
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Intervention groups
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Subjects will be assigned to receive either oral 25 mg soft gel containing lemon and cumin essential oil (intervention group: n=24), oral 75 mg soft gel containing lemon and cumin essential oil (intervention group: n=24) or placebo (control group: n=24).
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Main outcome variables
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Weight, fasting plasma glucose (FPG), serum insulin, insulin resistance, oxidative stress, lipid profiles and thyroid hormones
General information
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Reason for update
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Due to an error, the request for an update in our website has conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2015030812438N10
Registration date:
2015-03-25, 1394/01/05
Registration timing:
registered_while_recruiting
Last update:
2020-12-22, 1399/10/02
Update count:
1
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Registration date
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2015-03-25, 1394/01/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Barij Essence Company
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Expected recruitment start date
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2015-03-21, 1394/01/01
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Expected recruitment end date
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2015-03-30, 1394/01/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of oral soft gel containing lemon and cumin essential oil in various doses on weight in subjects with overweight and obesity
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Public title
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Effect of cumin and lemon on obesity
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Overweight or obesity (BMI ≥ 25 kg/m2)
Aged 18-50 years
Exclusion criteria:
BMI < 25 kg/m2
Hypertension
Thyroid disorders
Diabetes
Cardiovascular disorders
Pregnancy and lactation
The use of hormonal or anti-obesity medications
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Age
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From 18 years old to 50 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
72
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At study baseline and after stratification for pre-intervention BMI and age subjects will be randomly divided into three groups to take either high-dose C. cyminum L. and lime supplements (n =24) or low-dose C. cyminum L. and lime supplements (n = 24) or placebo (n = 24). Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2015-02-28, 1393/12/09
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Ethics committee reference number
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93210
Health conditions studied
1
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Description of health condition studied
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Overweight and Obesity
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ICD-10 code
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E66.9
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ICD-10 code description
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Obesity, unspecified
Primary outcomes
1
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Description
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Weight
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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scale
2
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Description
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Body Mass Index
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Calculation using formula
Secondary outcomes
1
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Description
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Total cholesterol
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic kit
2
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Description
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Insulin
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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ELISA kit
3
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Description
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Triglycerides
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic kit
4
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Description
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HDL-cholesterol
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic kit
5
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Description
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LDL-cholesterol
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic kit
6
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Description
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Glutathione
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
7
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Description
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Total antioxidant capacity
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
8
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Description
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Fasting blood sugar
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic kit
9
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Description
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Insulin resistance
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Calculation using HOMA formula
Intervention groups
1
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Description
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Intervention group: Oral soft gel containing lemon and cumin essential oil, 25 mg, twice a day, for 8 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Oral soft gel containing lemon and cumin essential oil, 75 mg, twice times a day, for 8 weeks orally
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Category
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Treatment - Drugs
3
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Description
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Control group: Placebo pearl, twice times a day, for 8 weeks orally.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available