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Completed

NCT Number: NCT05492279

Is Sheep Ghee Cardioprotective?

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

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Key information

Conditions

Cholesterol; Metabolic Disorder Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Inflammation Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

20 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Javad Kojuri

Shiraz, Fars, 7134814336, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sheep ghee

Dietary Supplement

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

Sunflower oil

Dietary Supplement

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

Primary outcomes

  1. LDL cholesterol

    Time frame: 2 months

    serum LDL level in mg/dl

  2. total cholesterol

    Time frame: 2 months

    serum total cholesterol in mg/dl

  3. HDL cholesterol

    Time frame: 2 months

    Serum HDL in mg/dl

  4. HS-CRP

    Time frame: 2 months

    HS-CRP level in picogram/dl

Secondary outcomes

  1. adverse effect

    Time frame: 2 months

    gastrointestinal, skin, allergy

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 8, 2022
Registry last updated
Aug 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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