Determination of Protocol of Nocturnal Food Intake of Shift Workers.

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

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.

Study Overview

• Status: Completed
• Conditions: Shift Work Type Circadian Rhythm Sleep Disorder
• Intervention / Treatment: Other: Normal protein diet; Other: High-protein diet

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Uberlândia, Minas Gerais, Brazil, 38405-320
      • Cibele Aparecida Crispim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shift workers; Night workers of the Hospital of Clinics of Uberlândia, Federal University of Uberlândia, received the normal protein diet.	Other: Normal protein diet; The intervention with the control diet was composed of 65% of carbohydrates, 15% of proteins and 20% of lipids.
Experimental: Night workers; Night workers of the Hospital of Clinics of Uberlândia, Federal University of Uberlândia, received the high-protein diet.	Other: High-protein diet; The intervention with the higher-protein diet was composed of 45% of carbohydrates, 35% of proteins and 20% of lipids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Federal University of Uberlandia
• Investigators: Principal Investigator: Cibele A Crispim, PhD, Federal University of Uberlândia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2017
• Primary Completion (Actual): January 11, 2018
• Study Completion (Actual): January 11, 2018

Study Registration Dates

• First Submitted: January 26, 2018
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): May 1, 2019
• Last Update Submitted That Met QC Criteria: April 30, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Sleep; Food intake; Shift work; Postprandial metabolic response
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Neurologic Manifestations; Occupational Diseases; Chronobiology Disorders; Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
• Other Study ID Numbers: CEP UFU 2250027/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No