Is Sheep Ghee Cardioprotective?

Sponsor

Shiraz University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT05492279

Collaborator

(none)

Enrollment

Location

Arms

28.9

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cholesterol; Metabolic Disorder Inflammation	Dietary Supplement: sheep ghee Dietary Supplement: sunflower oil	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

clinical trial randomizedclinical trial randomized

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

random allocation, open label

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 1, 2020

Actual Primary Completion Date :

Jun 1, 2022

Actual Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intervention 10 gr Sheep ghee	Dietary Supplement: sheep ghee natural sheep ghee, given to patient in a commercial box and intervention group 10 gr per day from sheep ghee
Active Comparator: control group 10 gr sunflower oil	Dietary Supplement: sunflower oil natural sunflower oil, given to patients in a commercial box and patient use 10 gr of it

Arm

Intervention/Treatment

Experimental: intervention

10 gr Sheep ghee

Dietary Supplement: sheep ghee

natural sheep ghee, given to patient in a commercial box and intervention group 10 gr per day from sheep ghee

Active Comparator: control group

10 gr sunflower oil

Dietary Supplement: sunflower oil

natural sunflower oil, given to patients in a commercial box and patient use 10 gr of it

Outcome Measures

Primary Outcome Measures

LDL cholesterol [2 months]
serum LDL level in mg/dl
total cholesterol [2 months]
serum total cholesterol in mg/dl
HDL cholesterol [2 months]
Serum HDL in mg/dl
HS-CRP [2 months]
HS-CRP level in picogram/dl

Secondary Outcome Measures

adverse effect [2 months]
gastrointestinal, skin, allergy

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 76 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Javad Kojuri	Shiraz	Fars	Iran, Islamic Republic of	7134814336

Sponsors and Collaborators

Shiraz University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Javad Kojuri, professor, Shiraz University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT05492279

Other Study ID Numbers:

98-01-01-22054

First Posted:

Aug 8, 2022

Last Update Posted:

Aug 8, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Javad Kojuri, professor, Shiraz University of Medical Sciences

Atherosclerosis

cardiovascular disease

high-sensitivity C-reactive protein

inflammation

sheep ghee

Additional relevant MeSH terms:

Metabolic Diseases

Inflammation

Study Results

No Results Posted as of Aug 8, 2022