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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05492279
Other study ID # 98-01-01-22054
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date July 1, 2022

Study information

Verified date August 2022
Source Shiraz University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Normal volunteers were randomly received Sheep ghee or sunflower oil, and before and after the study lipid profile and HS-CRP were measured.


Description:

During outpatient clinic visits, potentially eligible individuals were screened for enrollment according to the inclusion and exclusion criteria. Patients were randomly allocated into the treatment and control groups via the blocked randomization method. The control group received a normal diet for eight weeks with 10 g of sunflower oil. In the treatment group, sunflower oil was replaced with 10 g of sheep ghee. 50 patients in each group were enrollment. Patients' information, including demographic data and the serum levels of fasting blood sugar (FBS), LDL, HDL, triglyceride (TG), and hs-CRP, were recorded in datasheets twice: once before treatment with sheep ghee and once eight weeks later.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date July 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 76 Years
Eligibility Inclusion Criteria: - healthy adults, seeking outpatient visit at professor kojuri cardiology clinic Exclusion Criteria: - any history of ischemic heart disease (IHD), - coronary artery bypass grafting (CABG) - percutaneous intervention (PCI) - stroke - peripheral vascular diseases - use of anti-hyperlipidemic agents - unwillingness to participate. - Need of tight hyperlipidemia control.

Study Design


Intervention

Dietary Supplement:
sheep ghee
natural sheep ghee, given to patient in a commercial box and intervention group 10 gr per day from sheep ghee
sunflower oil
natural sunflower oil, given to patients in a commercial box and patient use 10 gr of it

Locations

Country Name City State
Iran, Islamic Republic of Javad Kojuri Shiraz Fars

Sponsors (1)

Lead Sponsor Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary LDL cholesterol serum LDL level in mg/dl 2 months
Primary total cholesterol serum total cholesterol in mg/dl 2 months
Primary HDL cholesterol Serum HDL in mg/dl 2 months
Primary HS-CRP HS-CRP level in picogram/dl 2 months
Secondary adverse effect gastrointestinal, skin, allergy 2 months
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