NCT05492279

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
Last Updated

August 8, 2022

Status Verified

August 1, 2022

Enrollment Period

2.3 years

First QC Date

August 5, 2022

Last Update Submit

August 5, 2022

Conditions

Keywords

Atherosclerosiscardiovascular diseasehigh-sensitivity C-reactive proteininflammationsheep ghee

Outcome Measures

Primary Outcomes (4)

  • LDL cholesterol

    serum LDL level in mg/dl

    2 months

  • total cholesterol

    serum total cholesterol in mg/dl

    2 months

  • HDL cholesterol

    Serum HDL in mg/dl

    2 months

  • HS-CRP

    HS-CRP level in picogram/dl

    2 months

Secondary Outcomes (1)

  • adverse effect

    2 months

Study Arms (2)

intervention

EXPERIMENTAL

10 gr Sheep ghee

Dietary Supplement: sheep ghee

control group

ACTIVE COMPARATOR

10 gr sunflower oil

Dietary Supplement: sunflower oil

Interventions

sheep gheeDIETARY_SUPPLEMENT

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

intervention
sunflower oilDIETARY_SUPPLEMENT

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

control group

Eligibility Criteria

Age20 Years - 76 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy adults, seeking outpatient visit at professor kojuri cardiology clinic

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Javad Kojuri

Shiraz, Fars, 7134814336, Iran

Location

MeSH Terms

Conditions

Metabolic DiseasesInflammationAtherosclerosisCardiovascular Diseases

Interventions

Sunflower Oil

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Plant OilsPlant PreparationsBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
random allocation, open label
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: clinical trial randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 5, 2022

First Posted

August 8, 2022

Study Start

February 1, 2020

Primary Completion

June 1, 2022

Study Completion

July 1, 2022

Last Updated

August 8, 2022

Record last verified: 2022-08

Locations