Clinical trial NCT03456219: Determination of Protocol of Nocturnal Food Intake of Shift Workers.
Official title: Determination of Protocol of Nocturnal Food Intake of Shift Workers: a Crossover Randomized and Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shift Work Type Circadian Rhythm Sleep Disorder
Keywords: Food intake
Sleep
Shift work
Postprandial metabolic response
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 14
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study evaluates the effect of different dietary conducts in the nocturnal period on the postprandial metabolism and food perceptions of night workers of the Hospital of Clinics of Uberlândia, Federal University of Uberlândia.

Detailed description: Due to imbalances in the circadian rhythm, shift workers may present inadequate eating habits, which provoke metabolic and nutritional disorders. In this crossover study the participants consumed, at different times and separated by 6 days interval, two meals pre-established at the time of night work: a control and a higher-protein. On the day of each intervention, the participants were evaluated for response of blood and subjective markers after meal (glucose, insulin, triglycerides and subjective perceptions related to ingestion after each meal). It is expected that the standardization of a glycemic reduction diet will improve the metabolic response of the workers, demonstrated in the results of the biochemical parameters. If this scenario is confirmed, it is still expected that the data and results obtained in this study may serve as subsidies for the elaboration of nutritional interventions consistent with the work routine at night.

Eligibility criteria: Inclusion Criteria:

* Male workers;
* Age between 20 and 60 years;
* Have been working night shift for at least six months;
* Sedentary.

Exclusion Criteria:

* Failure to provide the information or material necessary for the development of the study;
* Carriers of diseases previously diagnosed and under treatment, such as type 2 diabetes mellitus, hypertension, cardiovascular diseases and related mood disorders such as depression.

Primary outcomes:
measure: Change of metabolic parameters
timeFrame: 7 months
measure: Change of metabolic parameters
timeFrame: 7 months
measure: Change of metabolic parameters
timeFrame: 7 months
measure: Change of food perceptions
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Uberlândia
country: Brazil
facility: Cibele Aparecida Crispim
state: Minas Gerais
Study officials:
affiliation: Federal University of Uberlandia
name: CIBELE A CRISPIM, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cunha NB, Silva CM, Mota MC, Lima CA, Teixeira KRC, Cunha TM, Crispim CA. A High-Protein Meal during a Night Shift Does Not Improve Postprandial Metabolic Response the Following Breakfast: A Randomized Crossover Study with Night Workers. Nutrients. 2020 Jul 13;12(7):2071. doi: 10.3390/nu12072071.