- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03800732
The Influence of Nocturnal Food Intake in Eating Behavior of Night Workers
10. februar 2022 oppdatert 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
10
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Minas Gerais
-
Uberlândia, Minas Gerais, Brasil, 38.405-320
- Cibele Aparecida Crispim
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år til 50 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Preprandial metabolic
Tidsramme: 6 months
|
Ghrelin, GLP-1 - glucagon-like peptide 1, PYY-peptide YY
|
6 months
|
|
Change of food perceptions
Tidsramme: 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.
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Food behavior
Tidsramme: 6 months
|
Record of food consumption of the meals / snacks held following the test meal.
|
6 months
|
Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2019
Primær fullføring (Faktiske)
1. september 2019
Studiet fullført (Faktiske)
1. juli 2020
Datoer for studieregistrering
Først innsendt
9. januar 2019
Først innsendt som oppfylte QC-kriteriene
9. januar 2019
Først lagt ut (Faktiske)
11. januar 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. februar 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. februar 2022
Sist bekreftet
1. februar 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 86382218.6.0000.5152
Plan for individuelle deltakerdata (IPD)
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