Time of Day Effect on Pesticides Metabolism and Toxicity

NCT04177030 | Completed

• 1 other identifier: CUT3
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Diet Habit

Keywords

circadian clock; pesticides; fruits; vegetables; diet; time

Outcome Measures

Primary Outcomes (2)

• Change in concentrations of biomarkers of exposure to pesticides (ng/g) from 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

  the metabolomic profile in each period using a metabolomics platform

  up to day 8 in both periods since baseline

Secondary Outcomes (2)

• Change in levels of weight in kilograms

  up to day 8 in both periods since baseline

• Change in levels of waist circumference in centimeters

  up to day 8 in both periods since baseline

Study Arms (2)

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.

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.

Behavioral: Isopesticide dietary scheme

Interventions

Isopesticide dietary scheme BEHAVIORAL

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.

Also known as: Group A

Group A-Morning First

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cyprus University of Technology: lead

Study Sites (1)

Cyprus University of Technology

Limassol, Cyprus

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Konstantinos C Makris

  Cyprus University of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Konstantinos Makris, Associate Professor of Environmental Health

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 26, 2019
• Study Start: July 27, 2020
• Primary Completion: December 23, 2020
• Study Completion: June 30, 2021
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: upon publication, the data will become available.
• Access Criteria: the data will be publicly available

Locations

CY (1)