Determination of Protocol of Nocturnal Food Intake of Shift Workers.

Shift Work Type Circadian Rhythm Sleep Disorder Clinical Trial

Official title:

Determination of Protocol of Nocturnal Food Intake of Shift Workers: a Crossover Randomized and Controlled Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03456219
• Other study ID #: CEP UFU 2250027/2017
• Status: Completed
• Phase: N/A
• Start date: June 27, 2017
• Est. completion date: January 11, 2018

Study information

• Verified date: April 2019
• Source: Federal University of Uberlandia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 11, 2018
• Est. primary completion date: January 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parasomnias
• Shift Work Type Circadian Rhythm Sleep Disorder
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Intervention

Other:
• Normal protein diet
The intervention with the control diet was composed of 65% of carbohydrates, 15% of proteins and 20% of lipids.
• High-protein diet
The intervention with the higher-protein diet was composed of 45% of carbohydrates, 35% of proteins and 20% of lipids.

Locations

Country	Name	City	State
Brazil	Cibele Aparecida Crispim	Uberlândia	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Uberlandia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of metabolic parameters	Blood samples were collected before and after (30, 60, 90 and 120 minutes) the consumption of each of the meals at nighttime (work schedule). In the first meal of the following day (standard breakfast) were determined the serum concentrations of glucose (mg/dL).	7 months
Primary	Change of metabolic parameters	Blood samples were collected before and after (30, 60, 90 and 120 minutes) the consumption of each of the meals at nighttime (work schedule). In the first meal of the following day (standard breakfast) were determined the serum concentrations of insulin (mU/mL).	7 months
Primary	Change of metabolic parameters	Blood samples were collected before and after (30, 60, 90 and 120 minutes) the consumption of each of the meals at nighttime (work schedule). In the first meal of the following day (standard breakfast) were determined the serum concentrations of triglycerides (mg/dL).	7 months
Primary	Change of food perceptions	To evaluate appetite, satiety and postprandial satisfaction, a visual analogue scale called "hunger and satiety 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. There is no classification of the values obtained. The answers are subjective and used in a comparative way.	7 months