NCT03456219

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2018

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

January 26, 2018

Last Update Submit

April 30, 2019

Conditions

Keywords

Food intakeSleepShift workPostprandial metabolic response

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

EXPERIMENTAL

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

Other: Normal protein diet

Night workers

EXPERIMENTAL

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

Other: High-protein diet

Interventions

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

Shift workers

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

Night workers

Eligibility Criteria

Age20 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

MeSH Terms

Interventions

Diet, High-Protein

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • CIBELE A CRISPIM, PhD

    Federal University of Uberlandia

    PRINCIPAL INVESTIGATOR

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

Locations