- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05492279
Is Sheep Ghee Cardioprotective?
Effect of Sheep Ghee on Lipid Profile and High-sensitivity C-reactive Protein: A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Fars
-
Shiraz, Fars, Iran, Islamic Republic of, 7134814336
- Javad Kojuri
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention
10 gr 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
|
natural sunflower oil, given to patients in a commercial box and patient use 10 gr of it
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
LDL cholesterol
Time Frame: 2 months
|
serum LDL level in mg/dl
|
2 months
|
|
total cholesterol
Time Frame: 2 months
|
serum total cholesterol in mg/dl
|
2 months
|
|
HDL cholesterol
Time Frame: 2 months
|
Serum HDL in mg/dl
|
2 months
|
|
HS-CRP
Time Frame: 2 months
|
HS-CRP level in picogram/dl
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
adverse effect
Time Frame: 2 months
|
gastrointestinal, skin, allergy
|
2 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 98-01-01-22054
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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