Cholesterol; Metabolic DisorderNCT05492279
Is Sheep Ghee Cardioprotective?
A study testing sheep ghee and sunflower oil in people with Cholesterol; Metabolic Disorder and Inflammation, run by Shiraz University of Medical Sciences at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 20 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholesterol; Metabolic Disorder, Inflammation
- What is being tested?
- sheep ghee and sunflower oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- 1 Feb 2020to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adults, seeking outpatient visit at professor kojuri cardiology clinic
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sheep Ghee on Lipid Profile and High-sensitivity C-reactive Protein: A Randomized Clinical Trial
Normal volunteers were randomly received Sheep ghee or sunflower oil, and before and after the study lipid profile and HS-CRP were measured.
Read the 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.
- Conditions
- Cholesterol; Metabolic Disorder, Inflammation
- Being tested
- sheep ghee, sunflower oil
- Keywords
- Atherosclerosis, cardiovascular disease, high-sensitivity C-reactive protein, inflammation, sheep ghee
- Medical subject headings
- Metabolic Diseases, Inflammation, Atherosclerosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sheep gheeDietary supplement
natural sheep ghee, given to patient in a commercial box and intervention group 10 gr per day from sheep ghee
sunflower oilDietary supplement
natural sunflower oil, given to patients in a commercial box and patient use 10 gr of it
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | 10 gr Sheep ghee Receives: Dietary Supplement: sheep ghee |
| control group | Active comparator | 10 gr sunflower oil Receives: Dietary Supplement: sunflower oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL cholesterol
serum LDL level in mg/dl
Measured: 2 months
total cholesterol
serum total cholesterol in mg/dl
Measured: 2 months
HDL cholesterol
Serum HDL in mg/dl
Measured: 2 months
HS-CRP
HS-CRP level in picogram/dl
Measured: 2 months
Secondary outcomes (1)
adverse effect
gastrointestinal, skin, allergy
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Feb 2020
- Primary completion1 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholesterol; Metabolic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- clinical trial randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javad Kojuri, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492279
- Sponsor's protocol ID
- 98-01-01-22054
- Status last verified
- Aug 2022
- First submitted
- 5 Aug 2022
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sheep Ghee on Lipid Profile and High-sensitivity C-reactive Protein: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05492279
- Acronym / sponsor ID
- 98-01-01-22054
- Conditions
- Cholesterol; Metabolic Disorder, Inflammation
- Keywords
- Atherosclerosis, cardiovascular disease, high-sensitivity C-reactive protein, inflammation, sheep ghee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- clinical trial randomized
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Dietary Supplement: sheep ghee10 gr Sheep ghee |
| control group | Active comparator | Dietary Supplement: sunflower oil10 gr sunflower oil |
Who may qualify
- Ages
- 20 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy adults, seeking outpatient visit at professor kojuri cardiology clinic
Key exclusion criteria (8 listed)
- any history of ischemic heart disease (IHD),
- coronary artery bypass grafting (CABG)
- percutaneous intervention (PCI)
- stroke
- peripheral vascular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sheep gheenatural sheep ghee, given to patient in a commercial box and intervention group 10 gr per day from sheep ghee | Dietary supplement | intervention |
| sunflower oilnatural sunflower oil, given to patients in a commercial box and patient use 10 gr of it | Dietary supplement | control group |
Primary outcome
LDL cholesterol
Time frame: 2 months
serum LDL level in mg/dl
total cholesterol
Time frame: 2 months
serum total cholesterol in mg/dl
HDL cholesterol
Time frame: 2 months
Serum HDL in mg/dl
HS-CRP
Time frame: 2 months
HS-CRP level in picogram/dl
1 secondary outcome
adverse effect
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
Related trials for Cholesterol; Metabolic Disorder
Recruiting
Effect of a Grape Seed Proanthocyanidin Extract (GSPE) on LDL Cholesterol Levels in Rotating Night Shift Workers
Cardiovascular Diseases, Circadian Rhythm Sleep Disorder, Shift Work Type
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sheep ghee and sunflower oil in people with Cholesterol; Metabolic Disorder and Inflammation, run by Shiraz University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL cholesterol (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022; AzTrials last refreshed its copy on 1 Nov 2026.