Clinical Trial on the Effectiveness of Citrolive
CITROXI
1 other identifier
interventional
23
1 country
1
Brief Summary
The clinical trial consists in checking the antioxidant effect of citrolive on low density cholesterol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedFirst Posted
Study publicly available on registry
April 2, 2020
CompletedApril 2, 2020
March 1, 2020
2.2 years
October 16, 2019
March 30, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Blood pressure
The systolic and diastolic blood pressure was measured with an OMRON oscilimétrilo sphygmomanometer
The change in systolic and diastolic blood pressure is observed after three months of intake of the product under investigation
Biochemistry and blood count
the hematological profile is analyzed with the Horiba ABX Oentra 80 analyzer. Biochemical profile with the ILAB 600 analyzer
The change is observed after three months of intake of the product under investigation
Secondary Outcomes (7)
Weight
The change is observed after three months of intake of the product under investigation
Height
The change is observed after three months of intake of the product under investigation
BMI
The change is observed after three months of intake of the product under investigation
Perimeters
The change is observed after three months of intake of the product under investigation
Folds
The change is observed after three months of intake of the product under investigation
- +2 more secondary outcomes
Study Arms (2)
experimental group
EXPERIMENTALvolunteers consume 1 capsule per day for 3 months. (500 mg citrolive).
control group Placebo (sucrose)
PLACEBO COMPARATORvolunteers consume 1 capsule per day for 3 months. (saccharose).
Interventions
Eligibility Criteria
You may qualify if:
- Not belonging to the group of individuals considered as priorities by the Third Joint Task Force for the prevention of cardiovascular diseases due to high risk.
- Present total cholesterol figures greater than 200 milligrams / deciliter and / or low density cholesterol figures greater than 130 milligrams / deciliter so that after applying the cardiovascular risk table (SCORE) they present a current risk of less than 5% of suffer an ischemic event in a period of 10 years, being without pharmacological treatment.
- Present several cardiovascular risk factors with cholesterolemia figures close to 200 milligrams / deciliters and / or low density cholesterol figures close to 130 milligrams / deciliters.
You may not qualify if:
- \. chronic or terminal illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Catholic University of Murcia
Murcia, 30107, Spain
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 16, 2019
First Posted
April 2, 2020
Study Start
October 1, 2017
Primary Completion
November 30, 2019
Study Completion
February 1, 2020
Last Updated
April 2, 2020
Record last verified: 2020-03