Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04177030 |
Other study ID # |
CUT3 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 27, 2020 |
Est. completion date |
June 30, 2021 |
Study information
Verified date |
July 2022 |
Source |
Cyprus University of Technology |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The CIRCA-CHEM study is a non-pharmacological, randomized cross-over health intervention
trial studying the effect of the time of day on the metabolism and concomitant toxicity of
exposures to pesticides found in a balanced fruits and vegetables diet, providing the same
weekly portions of fruit and vegetables (isopesticide dietary scheme) but consumed in two
different time windows (morning vs. night).
Description:
The investigator's study is a 2x2 randomized cross over trial. All participants will be
randomly allocated to one of the two groups (morning vs night or night first and then
morning; Groups A and B, respectively) having to daily consume an isopesticide dietary
pattern (4:2 portions of fruits:vegetables) within a specific, time-restricted window for a
week and repeat the same procedure within a different time-restricted window for another week
after an in between wash-out period of one week. Morning time-restriction window is set to be
between 9am until 12pm and nighttime-restriction window is set between 7pm until 10pm,
respectively. Participants will be called to start time-restriction based on group
allocation.
In order for all participants to enter the study at a baseline level of pesticide load they
will be asked to undergo a run-in day where no fruit and vegetable consumption is allowed
prior the onset of the study. Within the first week of the study, Group A (n=25) will consume
fruits and vegetables within time-restriction morning window (9am-12pm) and Group B (n=25)
will consume fruits and vegetables within time-restriction night window (7pm-10pm). After
washout week period where participants will be called to return to their usual dietary
habits, two groups will swap to the opposite time-restriction window.
All participants should collect first morning urine samples on specific days during the first
week (1st, 3rd, 5th, 8th day) and during the third week (1st, 3rd, 5th, 8th day). Day
indicated as "8th", represents the first day of the following week (first day of the wash-out
week and first day of the fourth week which is the last day of the study). The participants
are asked to consume 4 portions of fruit and 2 portions of vegetables per day during the two
trial periods. The fruits selected for the study that will take place during winter season of
2020 are: a pear (~180g), a red apple (~170g), a banana (~110g) and an orange (~400g). The
vegetables selected include a tomato (~200g), two cucumbers (~240g) and lettuce (1 cup,4
chopped). All fruits and vegetables will be freshly and seasonally produced in Cyprus.
Overall, dietary daily consumption of foods and fluids will be monitored with the use of a
dietary diary throughout the study. Participants will also be asked to take a photograph of
the ready to be consumed fruit and vegetable on actual time of consumption and share photos
with research team in order to verify at a minimum whether the pre-set time-restriction
criteria have been met.