Measuring the Cardio-metabolic Response to Diet Quality Modification During Night Work.

Shift Work Clinical Trial

Official title:

Measuring the Cardio-metabolic Response to Diet Quality Modification During Night Work: Shift-eat (Night) Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04182867
• Other study ID #: Drum2019RG
• Status: Terminated
• Phase: N/A
• Start date: May 28, 2021
• Est. completion date: October 30, 2022

Study information

• Verified date: March 2022
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this pilot study is to investigate the acute impact of diet quality modification during night work on 24-hr glucose variability (GV) and heart rate variability (HRV) in healthy free-living employees.

Description:

An increasing body of data reports deterioration of cardio-metabolic health in shift workers. For example, large scale meta-analyses have reported shift workers to be at increased risk of developing type 2 diabetes and of experiencing a coronary event, compared to day working employees.

Shift work causes complex changes in physiology (desynchrony of circadian rhythms) and behaviors including activity, sleep and eating patterns. The importance of meal timing is becoming increasingly recognized in both chronobiology and nutrition fields, with emerging awareness of 'chrono-nutrition', the interaction between nutrition and circadian time.

Given the importance to the economy of a healthy aging workforce, and the increase in shift work prevalence, it is important to establish if diet modification can reduce the health disparities between shift and day working employees.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Current night shift worker (defined as a period of work between 11pm and 6am) working regular blocks of 3 night shifts.

• Body mass index between 18.5 and 35 kg/m2.

• Weight stable (no weight change by more than 3 kg in the last 2 months).

• Not a regular smoker (1 or more cigarettes per day) and would be willing not to smoke for the duration of the study.

• Not pregnant or breastfeeding.

• Not diagnosed with heart attack, stroke, angina, thrombosis, liver or kidney diseases, diabetes, chronic gastrointestinal disorder or cancer.

• Not currently taking medication to stabilize blood glucose (e.g. acarbose, metformin or sulfonylureas).

• Not started new medication within the last 3 months likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones.

• Do not take medication for blood pressure e.g. diuretics, (beta-blockers, Ca-channel, ACE inhibitors, Angiotensin Receptor blockers)

• Do not have diagnosed hypertension (high blood pressure, systolic blood pressure that is higher than 180 mmHg and or diastolic blood pressure that is higher than 110 mmHg).

• Not diagnosed with arterial fibrillation or any other condition that affects heart rate (e.g. arrhythmia).

• No food intolerance, allergies, hypersensitivity or follow any dietary restrictions (e.g. gluten intolerance, coeliac, lactose intolerance, vegan or vegetarian) that will prevent the ability to follow the test diets.

• Do not have a history substance abuse, or current high alcohol intake (>28 units/week for males and >21 units/week for females).

• Able to understand the information sheet and willing to comply with study protocol and able to follow dietary instructions before and during the study.

• Ability to prepare basic meals from ingredients provided.

• No travel arrangements outside UK within the period of data collection.

• Not already participating in a clinical trial.

• Able to give informed written consent.

Related Conditions & MeSH terms

• Shift Work

Intervention

Other:
• Dietary intervention
Dietary modification (provision of diet).

Locations

Country	Name	City	State
United Kingdom	Life Course Sciences	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose variability (mean amplitude of glycaemic excursions)	24-hr blood glucose variability measured by continuous glucose monitor	3 night shifts, an average of 72 hours
Primary	Blood glucose variability (coefficient variation)	24-hr blood glucose variability measured by continuous glucose monitor	3 night shifts, an average of 72 hours
Primary	Blood glucose variability (time in range)	24-hr blood glucose variability measured by continuous glucose monitor	3 night shifts, an average of 72 hours
Primary	Heart rate variability	24-hr heart rate variability measured by heart rate monitor	3 night shifts, an average of 72 hours
Secondary	Acceptability of test diet	Likert scale questionnaire	3 night shifts, an average of 72 hours