Is Sheep Ghee Cardioprotective?

Inflammation Clinical Trial

Official title:

Effect of Sheep Ghee on Lipid Profile and High-sensitivity C-reactive Protein: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05492279
• Other study ID #: 98-01-01-22054
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cholesterol; Metabolic Disorder
• Inflammation
• Metabolic Diseases

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