Eating Behaviors in Shift Workers

Eating Behavior Clinical Trial

Official title:

The Interaction of Shift Work and Food Environment on Eating Behaviors and Appetite

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04468672
• Other study ID #: AAAS8559
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2020
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Columbia University
• Contact: Mehreen Bhatti, BS
• Phone: 917-397-6451
• Email: mzb2107[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare eating behaviors and measures of hunger and fullness between day and night workers in order to better understand why night workers are at increased risk for obesity and related diseases.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Work ~ 8-hour shifts during day or night on 3 or more consecutive days of the week
• BMI 19-35 kg/m^2
• Age 20-55 years of age
• Metabolically healthy
• Weight stable over previous 3 months
• Lives in New York City area

Exclusion Criteria:

• Pregnant or less than 1 year postpartum at time of study
• Smoking
• History of drug or alcohol abuse
• Rotating shift work
• Habitual sleep duration of more than 6 hour per night
• Obstructive sleep apnea
• Transmeridian travel
• Type 2 diabetes
• Cardiovascular disease
• Hypertension
• Participation in diet or weight loss program in the 3 months prior to enrollment
• Psychiatric or sleep disorder
• Food allergies or intolerances
• Dislike of or unwillingness to eat test foods

Related Conditions & MeSH terms

• Eating Behavior
• Shift Work Type Circadian Rhythm Sleep Disorder
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Intervention

Behavioral:
• Portion size
The amount of food served (g) at the first two meals of each day. These amounts will vary across 4 weeks.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Food intake	Food by weight (g) in response to variations in portion served	24-hours intake period
Primary	Energy intake	Food by energy (kcal) in response to variations in portion served	24-hours intake period
Primary	Energy density consumed	Energy density consumed (kcal/g) in response to variations in portion served	24-hours intake period
Secondary	Appetite-regulating hormones	Appetite-regulating hormones, including Glucagon-like-peptide 1 (GLP-1) and ghrelin will be analyzed from plasma from whole blood samples collected while fasted and at 30, 60, 90, and 120 min postprandial. Area under the curve of plasma concentrations will be calculated for each individual appetite-regulating hormone	2-hours measurement period
Secondary	Hunger and fullness	Subjective measures related to hunger, fullness, and prospective consumption will be measured before and after meals via visual analog scales. The range of scores are 0 mm to 100 mm, with higher scores indicating greater feelings of the corresponding measure (e.g. greater hunger). Post-meal measures, adjusted for the corresponding pre-meal measure, will be analyzed as individual outcomes. Area under the curve will also be calculated for each measure.	24-hours measurement period