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Determination of Protocol of Nocturnal Food Intake of Shift Workers.

Primary Purpose

Shift Work Type Circadian Rhythm Sleep Disorder

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Normal protein diet
High-protein diet
Sponsored by
Federal University of Uberlandia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Shift Work Type Circadian Rhythm Sleep Disorder focused on measuring Food intake, Sleep, Shift work, Postprandial metabolic response

Eligibility Criteria

20 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Cibele Aparecida Crispim

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Shift workers

Night workers

Arm Description

Night workers of the Hospital of Clinics of Uberlândia, Federal University of Uberlândia, received the normal protein diet.

Night workers of the Hospital of Clinics of Uberlândia, Federal University of Uberlândia, received the high-protein diet.

Outcomes

Primary Outcome Measures

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).
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).
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).
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.

Secondary Outcome Measures

Full Information

First Posted
January 26, 2018
Last Updated
April 30, 2019
Sponsor
Federal University of Uberlandia
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1. Study Identification

Unique Protocol Identification Number
NCT03456219
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 27, 2017 (Actual)
Primary Completion Date
January 11, 2018 (Actual)
Study Completion Date
January 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Uberlandia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shift Work Type Circadian Rhythm Sleep Disorder
Keywords
Food intake, Sleep, Shift work, Postprandial metabolic response

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shift workers
Arm Type
Experimental
Arm Description
Night workers of the Hospital of Clinics of Uberlândia, Federal University of Uberlândia, received the normal protein diet.
Arm Title
Night workers
Arm Type
Experimental
Arm Description
Night workers of the Hospital of Clinics of Uberlândia, Federal University of Uberlândia, received the high-protein diet.
Intervention Type
Other
Intervention Name(s)
Normal protein diet
Intervention Description
The intervention with the control diet was composed of 65% of carbohydrates, 15% of proteins and 20% of lipids.
Intervention Type
Other
Intervention Name(s)
High-protein diet
Intervention Description
The intervention with the higher-protein diet was composed of 45% of carbohydrates, 35% of proteins and 20% of lipids.
Primary Outcome Measure Information:
Title
Change of metabolic parameters
Description
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).
Time Frame
7 months
Title
Change of metabolic parameters
Description
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).
Time Frame
7 months
Title
Change of metabolic parameters
Description
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).
Time Frame
7 months
Title
Change of food perceptions
Description
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.
Time Frame
7 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CIBELE A CRISPIM, PhD
Organizational Affiliation
Federal University of Uberlandia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cibele Aparecida Crispim
City
Uberlândia
State/Province
Minas Gerais
ZIP/Postal Code
38405-320
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32668588
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.
Results Reference
derived

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Determination of Protocol of Nocturnal Food Intake of Shift Workers.

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