Time of Day Effect on Pesticides Metabolism and Toxicity
Condition: Diet Habit
Study type: Interventional

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).
    

Detailed 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.
    

Intervention name(s): Isopesticide dietary scheme; Isopesticide dietary scheme
Intervention type(s): Behavioral; Behavioral
Intervention description(s): All participants should collect first morning urine samples on specific days during the first week and during the third week. 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. 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.; All participants should collect first morning urine samples on specific days during the first week and during the third week. 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. 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.
Other intervention name(s): Group A; Group B
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: circadian clock; pesticides; fruits; vegetables; diet; time