Diet HabitCIRCA-CHEMNCT04177030
Time of Day Effect on Pesticides Metabolism and Toxicity
A study testing Isopesticide dietary scheme in people with Diet Habit, run by Cyprus University of Technology at 1 site in Cyprus.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Habit
- What is being tested?
- Isopesticide dietary scheme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCyprus
- Study dates
- 27 Jul 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults (absence of any self-reported chronic or other known disease)
- Age:18-60
- Normal to overweight individuals (18.5 ≤ BMI <30)
- Permanent residents of Cyprus for the past 5 years
Who cannot join
- Chronically ill individuals (subjects with no self-reported chronic diseases)
- Age <18 years
- Obese individuals (BMI ≥30)
- Pregnant or lactating women
- Individuals with food allergies
- Systematic organic consuming individuals (more than 80% of their weekly meals)
- Individuals working shift schedule or having chronic sleep symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Diet Habit
- Being tested
- Isopesticide dietary scheme
- Keywords
- circadian clock, pesticides, fruits, vegetables, diet, time
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isopesticide dietary schemeBehavioural
Also called Group A
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.
Isopesticide dietary schemeBehavioural
Also called Group B
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A-Morning First | Experimental | 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. Receives: Behavioral: Isopesticide dietary scheme |
| Group B-Night First | Experimental | 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. Receives: Behavioral: Isopesticide dietary scheme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in concentrations of biomarkers of exposure to pesticides (ng/g) from baseline
pyrethroids and neonicotinoids urinary levels in each period
Measured: up to day 8 in both periods since baseline
Change in peak area counts of the metabolomic profile from baseline
the metabolomic profile in each period using a metabolomics platform
Measured: up to day 8 in both periods since baseline
Secondary outcomes (2)
Change in levels of weight in kilograms
weight measurements
Measured: up to day 8 in both periods since baseline
Change in levels of waist circumference in centimeters
waist circumference measurements
Measured: up to day 8 in both periods since baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start27 Jul 2020
- Primary completion23 Dec 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyprus University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Makris, Cyprus University of Technology
- Investigators
- Konstantinos C Makris, Principal investigator, Cyprus University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177030
- Sponsor's protocol ID
- CUT3
- Acronym
- CIRCA-CHEM
- Status last verified
- Jul 2022
- First submitted
- 20 Nov 2019
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon publication the individual participant data (in anonymized form) will be available through the journal's website.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time of Day Effect on Pesticides Metabolism and Toxicity - the CIRCA CHEM Pilot Trial
- ClinicalTrials.gov ID
- NCT04177030
- Acronym / sponsor ID
- CIRCA-CHEM / CUT3
- Conditions
- Diet Habit
- Keywords
- circadian clock, pesticides, fruits, vegetables, diet, time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cyprus University of TechnologyUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 23 Dec 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A-Morning First | Experimental | Behavioral: Isopesticide dietary schemeWithin 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. |
| Group B-Night First | Experimental | Behavioral: Isopesticide dietary schemeWithin 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adults (absence of any self-reported chronic or other known disease)
- Age:18-60
- Normal to overweight individuals (18.5 ≤ BMI <30)
- Permanent residents of Cyprus for the past 5 years
Key exclusion criteria (7 listed)
- Chronically ill individuals (subjects with no self-reported chronic diseases)
- Age <18 years
- Obese individuals (BMI ≥30)
- Pregnant or lactating women
- Individuals with food allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isopesticide dietary schemeAlso: Group AAll 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. | Behavioural | Group A-Morning First |
| Isopesticide dietary schemeAlso: Group BAll 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. | Behavioural | Group B-Night First |
Primary outcome
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
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
2 secondary outcomes
Change in levels of weight in kilograms
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: Yes. Upon publication the individual participant data (in anonymized form) will be available through the journal's website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantinos C Makris principal investigator
Cyprus University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isopesticide dietary scheme in people with Diet Habit, run by Cyprus University of Technology at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in concentrations of biomarkers of exposure to pesticides (ng/g) from baseline (time frame: up to day 8 in both periods since baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.