To compare the effects of a diet rich in olive oil and a diet rich in ghee on plasma total, LDL, and HDL cholesterol, apo B, TG as well as insulin, adiponectin and liver enzyme in healthy adults.
Design
A randomized, crossover intervention, not blinded, on 30 subjects. A table of random numbers will be used for randomization.
Settings and conduct
The study will involve a 2-week run-in period using reference oil (olive oil) at the end of which baseline measurements will be made. Subjects will then be randomized to one of the two treatments for a period of 4 weeks with two 2-week washout periods in between during which reference oil will be consumed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
I. Adult male and non-menopausal female aged 20-60 year
Exclusion criteria:
I. History of type 2 diabetes or atherosclerotic disease
II. Abnormal liver function test (ALT and AST > 45 U/L )
III. Abnormal kidney function test (createnine > 1.4 mg/dL)
IV. On lipid lowering medication
V. Pregnancy and breast feeding
VI. Female on oral contraceptive unless they have no intention to change during the study.
Intervention groups
Diet with ghee
Diet with refined olive oil
Main outcome variables
Plasma LDL-Cholesterol and Apo B
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160702028742N9
Registration date:2021-01-05, 1399/10/16
Registration timing:registered_while_recruiting
Last update:2021-01-05, 1399/10/16
Update count:0
Registration date
2021-01-05, 1399/10/16
Registrant information
Name
Javad Nasrollahzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2236 0656
Email address
jnasrolah@razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-02, 1399/10/13
Expected recruitment end date
2021-02-20, 1399/12/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing of the effects of olive oil and ghee consumption on plasma lipids and lipoproteins, adiponectin, and insulin in healthy adults
Public title
ٍffects of ghee consumption on plasma lipids in healthy adults
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
I. Adult male and non-menopausal female aged 20-60 year
Exclusion criteria:
I. History of type 2 diabetes
I. History of coronary heart disease
II. Abnormal liver function test (ALT and AST > 45 U/L )
III. Abnormal kidney function test (createnine > 1.4 mg/dL)
IV. On lipid lowering medication
V. Pregnancy and breast feeding
VI. Female on oral contraceptive unless they have no intention to change during the study
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method is performed using computer randomization software. For this purpose, in order to randomize whether the consumption of ghee by each person will be first or the second treatment, each person's number will be entered in Excel software and then they are randomized using the RAND function. The first 15 participants will begin study by consuming ghee and the next 15 will begin by consuming the olive oil.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Nutrition and Food Technology Research Institute Ethic Committee
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2020-12-01, 1399/09/11
Ethics committee reference number
IR.SBMU.nnftri.Rec.1399.053
Health conditions studied
1
Description of health condition studied
healthy subjects
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Plasma LDL-cholesterol
Timepoint
Measurements at baseline (before the start of the intervention) and 4 weeks after the start
Method of measurement
Spectrophotometry
2
Description
Plasma apo B levels
Timepoint
Measurements at baseline (before the start of the intervention) and 4 weeks after the start
Method of measurement
Spectrophotometry
Secondary outcomes
1
Description
Plasma TG
Timepoint
Measurements at baseline and 4 weeks after each intervention
Method of measurement
Spectrophotometry
2
Description
Plasma ALT
Timepoint
Measurements at baseline and 4 weeks after each intervention
Method of measurement
Spectrophotometry
3
Description
Plasma Insulin levels
Timepoint
Measurements at baseline and 4 weeks after each intervention
Method of measurement
ELISA
4
Description
Plasma Adiponectin levels
Timepoint
Measurements at baseline and 4 weeks after each intervention
Method of measurement
ELISA
Intervention groups
1
Description
Intervention group: Consume ghee in the diet for 4 weeks. The approximate amount of oil allowed for each person to prepare each of the two meals of lunch and dinner is determined and they are asked that the amount of oil needed to cook food in each of the two meals of lunch and dinner is specified in the amount. People are also advised to consume low-fat animal sources (dairy and meat products).
Category
Lifestyle
2
Description
Control group: Consumption of olive oil in the diet. The approximate amount of oil allowed for each person to prepare each of the two meals of lunch and dinner is determined and they are asked that the amount of oil needed to cook food in each of the two meals of lunch and dinner is specified in the amount. People are also advised to consume low-fat animal sources (dairy and meat products).
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Nutrition and Diet therapy
Full name of responsible person
Susan Mohammadi
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2237 6420
Email
s.Mohamadi.sm62@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2236 0658
Email
nnftri_food@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Javand Nasrollahzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7424
Email
jnasrollahzadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Javad Nasrollahzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7424
Email
jnasrollahzadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Javad Nasrollahzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7424
Email
jnasrollahzadeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available