The Influence of Nocturnal Food Intake in Eating Behavior of Night Workers
Primary Purpose
Shift Work Type Circadian Rhythm Sleep Disorder
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
With Meal during night work
Without Meal during night work
Sleep night
Sponsored by
About this trial
This is an interventional prevention trial for Shift Work Type Circadian Rhythm Sleep Disorder
Eligibility Criteria
Inclusion Criteria:
- Agree to participate in the study and sign the Informed Consent Form (EHIC).
- No significant changes in body mass in the last 6 months.
- With stable food and sleep routine in the last two months.
Exclusion Criteria:
- Failure to provide the information or material necessary for the development of the study.
- Report of chronic non-communicable diseases.
- Report of diagnosed and untreated psychiatric disorders.
Sites / Locations
- Cibele Aparecida Crispim
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Night workers.
Arm Description
Night workers of the military police of Minas Gerais, Uberlândia, who will participate in the three interventions of the study.
Outcomes
Primary Outcome Measures
Preprandial metabolic
Ghrelin, GLP-1 - glucagon-like peptide 1, PYY-peptide YY
Change of food perceptions
To evaluate appetite, satiety and postprandial satisfaction, a visual analogue scale was applied before and after consumption of the proposed meal, with the questions, "How much hunger did you have before the meal?"; "After the meal, how did you feel?"; "How much did you like the meal?", Signaling all responses on a 0 to 10 cm scale.
Secondary Outcome Measures
Food behavior
Record of food consumption of the meals / snacks held following the test meal.
Full Information
NCT ID
NCT03800732
First Posted
January 9, 2019
Last Updated
February 10, 2022
Sponsor
Federal University of Uberlandia
1. Study Identification
Unique Protocol Identification Number
NCT03800732
Brief Title
The Influence of Nocturnal Food Intake in Eating Behavior of Night Workers
Official Title
The Influence of Nocturnal Food Intake in Eating Behavior of Night Workers: Randomized Cross-over Study.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
July 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Uberlandia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aimed to verify the influence of night work and food intake during the night shift on the eating behavior of fixed night workers the next day.
Detailed Description
Night work causes restriction of sleep time and circadian misalignment and, therefore, have been associated with nutritional and metabolic impairments. The objective of the present study is to verify the influence of night work and food intake in this period on the behavior of the following day. The workers selected by criteria and inclusion and exclusion will be evaluated at the baseline: anthropometric parameters, food consumption and perception, duration of food consumption, sleep habits and chronobiological pattern (sleep monitoring by actigraphy, chronotype, social jet lag), parameters biochemical (blood count, lipidogram, C-reactive protein, cortisol, glucose, insulin).Subsequently, 30 workers will integrate a randomized and controlled crossover clinical study with three randomly established interventions: (1) two nights of work without meals during the shift; (2) two nights of work with a meal during the shift; (3) two nights sleep. Participants will go to the laboratory the morning after the second night of each condition to offer a test meal ad libitum, which will consist of foods of various compositions and food groups. Preprandial metabolic assessments will be conducted (ghrelin, GLP-1 - glucagon-like peptide 1, PYY-peptide YY). The following postprandial evaluations will be carried out and in the 24 hours following the experiment: food choices (record of all foods) and food perceptions (hunger, appetite, satiety and eating). It is expected to determine how nocturnal versus nocturnal work, and nocturnal fasting versus nocturnal fasting affect the next day's food choices.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shift Work Type Circadian Rhythm Sleep Disorder
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Night workers.
Arm Type
Experimental
Arm Description
Night workers of the military police of Minas Gerais, Uberlândia, who will participate in the three interventions of the study.
Intervention Type
Other
Intervention Name(s)
With Meal during night work
Intervention Description
Two nights of work with a meal during the shift and after will go to the laboratory the morning for eating a test meal ad libitum, which will consist of foods of various compositions and food groups. Preprandial metabolic assessments will be conducted (ghrelin, GLP-1 - glucagon-like peptide 1, PYY-peptide YY). The following postprandial evaluations will be carried out and in the 24 hours following the experiment: food choices (record of all foods) and food perceptions (hunger, appetite, satiety and eating).
Intervention Type
Other
Intervention Name(s)
Without Meal during night work
Intervention Description
Two nights of work without a meal during the shift and after will go to the laboratory the morning for eating a test meal ad libitum, which will consist of foods of various compositions and food groups. Preprandial metabolic assessments will be conducted (ghrelin, GLP-1 - glucagon-like peptide 1, PYY-peptide YY). The following postprandial evaluations will be carried out and in the 24 hours following the experiment: food choices (record of all foods) and food perceptions (hunger, appetite, satiety and eating).
Intervention Type
Other
Intervention Name(s)
Sleep night
Intervention Description
Two sleep nights and after will go to the laboratory the morning for eating a test meal ad libitum, which will consist of foods of various compositions and food groups. Preprandial metabolic assessments will be conducted (ghrelin, GLP-1 - glucagon-like peptide 1, PYY-peptide YY). The following postprandial evaluations will be carried out and in the 24 hours following the experiment: food choices (record of all foods) and food perceptions (hunger, appetite, satiety and eating).
Primary Outcome Measure Information:
Title
Preprandial metabolic
Description
Ghrelin, GLP-1 - glucagon-like peptide 1, PYY-peptide YY
Time Frame
6 months
Title
Change of food perceptions
Description
To evaluate appetite, satiety and postprandial satisfaction, a visual analogue scale was applied before and after consumption of the proposed meal, with the questions, "How much hunger did you have before the meal?"; "After the meal, how did you feel?"; "How much did you like the meal?", Signaling all responses on a 0 to 10 cm scale.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Food behavior
Description
Record of food consumption of the meals / snacks held following the test meal.
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Agree to participate in the study and sign the Informed Consent Form (EHIC).
No significant changes in body mass in the last 6 months.
With stable food and sleep routine in the last two months.
Exclusion Criteria:
Failure to provide the information or material necessary for the development of the study.
Report of chronic non-communicable diseases.
Report of diagnosed and untreated psychiatric disorders.
Facility Information:
Facility Name
Cibele Aparecida Crispim
City
Uberlândia
State/Province
Minas Gerais
ZIP/Postal Code
38.405-320
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Influence of Nocturnal Food Intake in Eating Behavior of Night Workers
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