Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
28 June 2021 |
Main ID: |
NCT02847117 |
Date of registration:
|
25/07/2016 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Bioavailability of the Microconstituents of Natural Chios Mastiha in Healthy Adults.
|
Scientific title:
|
A Bioavailability Study of the Natural Chios Mastiha in Blood and Urine Samples of Healthy Adults. |
Date of first enrolment:
|
July 2016 |
Target sample size:
|
20 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT02847117 |
Study type:
|
Interventional |
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Greece
| | | | | | | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Age: 20-40 years old
- BMI: 18.5-24.9 kg/m2
Exclusion Criteria:
- BMI > 25 kg/m2
- Alcohol or drug abuse
- Medication, vitamin or inorganic supplements
- Vegan or macrobiotic diet before and during the study
- Gastrointestinal diseases, such as IBD, peptic ulcer or GI cancer
Age minimum:
20 Years
Age maximum:
40 Years
Gender:
Male
|
Health Condition(s) or Problem(s) studied
|
Biological Availability
|
Intervention(s)
|
Other: Mastiha
|
Primary Outcome(s)
|
Phenolic and terpenoid content or metabolites of Mastiha identification
[Time Frame: The phenolic and terpenoid content or metabolites of Mastiha will be identified in plasma samples applying LC-HRMS. Data will be presented through study completion, an average of 1 year.]
|
Targeted and untargeted metabolic profile assessment
[Time Frame: Plasma metabolites assessment with GC-MS, LC-HRMS and urine metabolites assessment with NMR will take place . Data will be presented through study completion, an average of 1 year.]
|
Secondary Outcome(s)
|
Oxidative stress assessment
[Time Frame: Serum resistance to oxidation will be assessed through the CuSO4 technique, oxidised LDL levels and uric acid levels. F-2 isoprostanes determination will take place in urine samples. Data will be presented through study completion, an average of 1 year.]
|
Secondary ID(s)
|
Mastiha BIO-GR (304)
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|