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Is Sheep Ghee Cardioprotective?

Primary Purpose

Cholesterol; Metabolic Disorder, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
sheep ghee
sunflower oil
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholesterol; Metabolic Disorder focused on measuring Atherosclerosis, cardiovascular disease, high-sensitivity C-reactive protein, inflammation, sheep ghee

Eligibility Criteria

20 Years - 76 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Javad Kojuri

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

intervention

control group

Arm Description

10 gr Sheep ghee

10 gr sunflower oil

Outcomes

Primary Outcome Measures

LDL cholesterol
serum LDL level in mg/dl
total cholesterol
serum total cholesterol in mg/dl
HDL cholesterol
Serum HDL in mg/dl
HS-CRP
HS-CRP level in picogram/dl

Secondary Outcome Measures

adverse effect
gastrointestinal, skin, allergy

Full Information

First Posted
August 5, 2022
Last Updated
August 5, 2022
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05492279
Brief Title
Is Sheep Ghee Cardioprotective?
Official Title
Effect of Sheep Ghee on Lipid Profile and High-sensitivity C-reactive Protein: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholesterol; Metabolic Disorder, Inflammation
Keywords
Atherosclerosis, cardiovascular disease, high-sensitivity C-reactive protein, inflammation, sheep ghee

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
clinical trial randomized
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
random allocation, open label
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
10 gr Sheep ghee
Arm Title
control group
Arm Type
Active Comparator
Arm Description
10 gr sunflower oil
Intervention Type
Dietary Supplement
Intervention Name(s)
sheep ghee
Intervention Description
natural sheep ghee, given to patient in a commercial box and intervention group 10 gr per day from sheep ghee
Intervention Type
Dietary Supplement
Intervention Name(s)
sunflower oil
Intervention Description
natural sunflower oil, given to patients in a commercial box and patient use 10 gr of it
Primary Outcome Measure Information:
Title
LDL cholesterol
Description
serum LDL level in mg/dl
Time Frame
2 months
Title
total cholesterol
Description
serum total cholesterol in mg/dl
Time Frame
2 months
Title
HDL cholesterol
Description
Serum HDL in mg/dl
Time Frame
2 months
Title
HS-CRP
Description
HS-CRP level in picogram/dl
Time Frame
2 months
Secondary Outcome Measure Information:
Title
adverse effect
Description
gastrointestinal, skin, allergy
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Javad Kojuri
City
Shiraz
State/Province
Fars
ZIP/Postal Code
7134814336
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Is Sheep Ghee Cardioprotective?

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