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Completed

NCT Number: NCT03456219

Determination of Protocol of Nocturnal Food Intake of Shift Workers.

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.

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Key information

Conditions

Shift Work Type Circadian Rhythm Sleep Disorder

Age range

20 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cibele Aparecida Crispim

Uberlândia, Minas Gerais, 38405-320, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Normal protein diet

Other

The intervention with the control diet was composed of 65% of carbohydrates, 15% of proteins and 20% of lipids.

High-protein diet

Other

The intervention with the higher-protein diet was composed of 45% of carbohydrates, 35% of proteins and 20% of lipids.

Primary outcomes

  1. Change of metabolic parameters

    Time frame: 7 months

    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).

  2. Change of metabolic parameters

    Time frame: 7 months

    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).

  3. Change of metabolic parameters

    Time frame: 7 months

    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).

  4. Change of food perceptions

    Time frame: 7 months

    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.

Sponsors and collaborators

Lead sponsor

Federal University of Uberlandia

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 7, 2018
Registry last updated
May 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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