NCT03800732

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

February 14, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

January 9, 2019

Last Update Submit

February 10, 2022

Conditions

Shift Work Type Circadian Rhythm Sleep Disorder

Outcome Measures

Primary Outcomes (2)

  • Preprandial metabolic

    Ghrelin, GLP-1 - glucagon-like peptide 1, PYY-peptide YY

    6 months

  • 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.

    6 months

Secondary Outcomes (1)

  • Food behavior

    6 months

Study Arms (1)

Night workers.

EXPERIMENTAL

Night workers of the military police of Minas Gerais, Uberlândia, who will participate in the three interventions of the study.

Other: With Meal during night workOther: Without Meal during night workOther: Sleep night

Interventions

With Meal during night workOTHER

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).

Night workers.
Without Meal during night workOTHER

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).

Night workers.
Sleep nightOTHER

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).

Night workers.

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cibele Aparecida Crispim

Uberlândia, Minas Gerais, 38.405-320, Brazil

Location

Related Publications (1)

  • Teixeira BS, Silva CM, Silva ATF, Santos LLD, de Paiva Maia YC, Pedrazzoli M, Wright KP Jr, Crispim CA. Influence of fasting during the night shift on next day eating behavior, hunger, and glucose and insulin levels: a randomized, three-condition, crossover trial. Eur J Nutr. 2023 Apr;62(3):1281-1293. doi: 10.1007/s00394-022-03069-6. Epub 2022 Dec 17.

    PMID: 36526739DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 11, 2019

Study Start

January 1, 2019

Primary Completion

September 1, 2019

Study Completion

July 1, 2020

Last Updated

February 14, 2022

Record last verified: 2022-02

Locations

BR(1)