The Effect of Dates on Plasma Lipids, Oxidative Stress and the Atherogenicity of Serum in Healthy Adults
Primary Purpose
Atherosclerosis
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
dates
Sponsored by
About this trial
This is an interventional prevention trial for Atherosclerosis
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteers
Exclusion Criteria:
Sites / Locations
- Emek Medical Center
Outcomes
Primary Outcome Measures
serum oxidative stress
Secondary Outcome Measures
serum lipid profile
Full Information
NCT ID
NCT00750789
First Posted
August 17, 2008
Last Updated
September 10, 2008
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT00750789
Brief Title
The Effect of Dates on Plasma Lipids, Oxidative Stress and the Atherogenicity of Serum in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
November 2008 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
It has been proven in in-vitro studies that dates decrease the oxidative stress in serum. There have been no in-vivo studies to this date. The current study aims to test whether dates consumption by healthy adults decreases serum oxidative stress and improves serum PON1 activity and serum lipid profile.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
dates
Intervention Description
5 maedjool dates or 7 emery dates per day for 2 weeks each with a washout period of 2 weeks between
Primary Outcome Measure Information:
Title
serum oxidative stress
Time Frame
30 days
Secondary Outcome Measure Information:
Title
serum lipid profile
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers
Exclusion Criteria:
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wasseem Rock, MD
Phone
04-6495135
Email
wasseem_rock@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wasseem Rock
Organizational Affiliation
Emek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emek Medical Center
City
Afula
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wasseem Rock, MD
Phone
04-6495135
12. IPD Sharing Statement
Learn more about this trial
The Effect of Dates on Plasma Lipids, Oxidative Stress and the Atherogenicity of Serum in Healthy Adults
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