Time of Day Effect on Pesticides Metabolism and Toxicity (CIRCA-CHEM)

July 19, 2022 updated by: Konstantinos Makris, Cyprus University of Technology

Time of Day Effect on Pesticides Metabolism and Toxicity - the CIRCA CHEM Pilot Trial

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
      • Limassol, Cyprus
        • Cyprus University of Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy adults (absence of any self-reported chronic or other known disease)
  2. Age:18-60
  3. Normal to overweight individuals (18.5 ≤ BMI <30)
  4. Permanent residents of Cyprus for the past 5 years

Exclusion Criteria:

  1. Chronically ill individuals (subjects with no self-reported chronic diseases)
  2. Age <18 years
  3. Obese individuals (BMI ≥30)
  4. Pregnant or lactating women
  5. Individuals with food allergies
  6. Systematic organic consuming individuals (more than 80% of their weekly meals)
  7. Individuals working shift schedule or having chronic sleep symptoms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A-Morning First
Within the first week of the study, Group A will consume fruits and vegetables within time-restriction morning window (9am-12pm). Following washout week, Group A will consume fruits and vegetables within time-restriction night window (7pm-10pm) for one week.
Behavioral: Isopesticide dietary scheme
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 Names:
  • Group B
Experimental: Group B-Night First
Within the first week of the study, Group B will consume fruits and vegetables within time-restriction night window (7pm-10pm). Following washout week, Group B will consume fruits and vegetables within time-restriction morning window (9am-12pm) for one week.
Behavioral: Isopesticide dietary scheme
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 Names:
  • Group B

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in concentrations of biomarkers of exposure to pesticides (ng/g) from baseline
Time Frame: up to day 8 in both periods since baseline
pyrethroids and neonicotinoids urinary levels in each period
up to day 8 in both periods since baseline
Change in peak area counts of the metabolomic profile from baseline
Time Frame: up to day 8 in both periods since baseline
the metabolomic profile in each period using a metabolomics platform
up to day 8 in both periods since baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in levels of weight in kilograms
Time Frame: up to day 8 in both periods since baseline
weight measurements
up to day 8 in both periods since baseline
Change in levels of waist circumference in centimeters
Time Frame: up to day 8 in both periods since baseline
waist circumference measurements
up to day 8 in both periods since baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cyprus University of Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Konstantinos C Makris, Cyprus University of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CUT3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Upon publication the individual participant data (in anonymized form) will be available through the journal's website.

IPD Sharing Time Frame

upon publication, the data will become available.

IPD Sharing Access Criteria

the data will be publicly available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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