Determination of Protocol of Nocturnal Food Intake of Shift Workers.
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 11, 2018
CompletedFirst Submitted
Initial submission to the registry
January 26, 2018
CompletedFirst Posted
Study publicly available on registry
March 7, 2018
CompletedMay 1, 2019
April 1, 2019
7 months
January 26, 2018
April 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
Shift workers
EXPERIMENTALNight workers of the Hospital of Clinics of Uberlândia, Federal University of Uberlândia, received the normal protein diet.
Night workers
EXPERIMENTALNight workers of the Hospital of Clinics of Uberlândia, Federal University of Uberlândia, received the high-protein diet.
Interventions
The intervention with the control diet was composed of 65% of carbohydrates, 15% of proteins and 20% of lipids.
The intervention with the higher-protein diet was composed of 45% of carbohydrates, 35% of proteins and 20% of lipids.
Eligibility Criteria
You may qualify if:
- Male workers;
- Age between 20 and 60 years;
- Have been working night shift for at least six months;
- Sedentary.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cibele Aparecida Crispim
Uberlândia, Minas Gerais, 38405-320, Brazil
Related Publications (1)
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.
PMID: 32668588DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
CIBELE A CRISPIM, PhD
Federal University of Uberlandia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
January 26, 2018
First Posted
March 7, 2018
Study Start
June 27, 2017
Primary Completion
January 11, 2018
Study Completion
January 11, 2018
Last Updated
May 1, 2019
Record last verified: 2019-04