- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03800732
The Influence of Nocturnal Food Intake in Eating Behavior of Night Workers
10 februari 2022 uppdaterad av: Cibele Aparecida Crispim, Federal University of Uberlandia
The Influence of Nocturnal Food Intake in Eating Behavior of Night Workers: Randomized Cross-over Study.
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
10
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Minas Gerais
-
Uberlândia, Minas Gerais, Brasilien, 38.405-320
- Cibele Aparecida Crispim
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år till 50 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Night workers.
Night workers of the military police of Minas Gerais, Uberlândia, who will participate in the three interventions of the study.
|
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).
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).
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).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Preprandial metabolic
Tidsram: 6 months
|
Ghrelin, GLP-1 - glucagon-like peptide 1, PYY-peptide YY
|
6 months
|
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Change of food perceptions
Tidsram: 6 months
|
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.
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6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Food behavior
Tidsram: 6 months
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Record of food consumption of the meals / snacks held following the test meal.
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6 months
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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 januari 2019
Primärt slutförande (Faktisk)
1 september 2019
Avslutad studie (Faktisk)
1 juli 2020
Studieregistreringsdatum
Först inskickad
9 januari 2019
Först inskickad som uppfyllde QC-kriterierna
9 januari 2019
Första postat (Faktisk)
11 januari 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 februari 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 februari 2022
Senast verifierad
1 februari 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 86382218.6.0000.5152
Plan för individuella deltagardata (IPD)
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