Determination of Protocol of Nocturnal Food Intake of Shift Workers.

• Sponsor: Federal University of Uberlandia (Other)
• Overall Status: Completed
• CT.gov ID: NCT03456219
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.5
• Patients Per Site Per Month: 2.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Shift Work Type Circadian Rhythm Sleep Disorder	Other: Normal protein diet; Other: High-protein diet	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Determination of Protocol of Nocturnal Food Intake of Shift Workers: a Crossover Randomized and Controlled Study.
• Actual Study Start Date: Jun 27, 2017
• Actual Primary Completion Date: Jan 11, 2018
• Actual Study Completion Date: Jan 11, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change of metabolic parameters [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cibele Aparecida Crispim	Uberlândia	Minas Gerais	Brazil	38405-320

Sponsors and Collaborators

• Federal University of Uberlandia

Investigators

• Principal Investigator: CIBELE A CRISPIM, PhD, Federal University of Uberlandia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cibele Aparecida Crispim, Principal investigator, Federal University of Uberlandia
• ClinicalTrials.gov Identifier: NCT03456219
• Other Study ID Numbers: CEP UFU 2250027/2017
• First Posted: Mar 7, 2018
• Last Update Posted: May 1, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Cibele Aparecida Crispim, Principal investigator, Federal University of Uberlandia: Food intake; Sleep; Shift work; Postprandial metabolic response
• Additional relevant MeSH terms: Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm

Study Results

No Results Posted as of May 1, 2019