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

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

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.

Study Overview

• Status: Terminated
• Conditions: Shift Work
• Intervention / Treatment: Other: Dietary intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 9NH
    • Life Course Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UK dietary guideline diet; A 4-day diet (food and beverage provision for 3 meals and 2 snacks) will be provided along with an eating plan (time of each meal / snack). The experimental diet will meet UK dietary guidelines for fiber, salt, sugar, saturated fat, fruit and vegetable intake. Energy (calorie) requirements for each participant will be calculated from age, sex and weight of the participant. The diet will be consumed across 3 consecutive night shifts.	Other: Dietary intervention; Dietary modification (provision of diet).
Other: Shift worker diet; A 4-day diet (food and beverage provision for 3 meals and 2 snacks) will be provided along with an eating plan (time of each meal / snack). Typical 'shift diet' based on previous research investigating what UK night workers eat. The 'shift diet' will contain ~15% energy from added sugar, 15g fiber, 2.5 portions fruit/vegetable, no whole grains. Required energy intake (calories) for each day to maintain their current body weight. Energy (calorie) requirements for each participant will be calculated from age, sex and weight of the participant.The diet will be consumed across 3 consecutive night shifts.	Other: Dietary intervention; Dietary modification (provision of diet).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Blood glucose variability (coefficient variation)	24-hr blood glucose variability measured by continuous glucose monitor	3 night shifts, an average of 72 hours
Blood glucose variability (time in range)	24-hr blood glucose variability measured by continuous glucose monitor	3 night shifts, an average of 72 hours
Heart rate variability	24-hr heart rate variability measured by heart rate monitor	3 night shifts, an average of 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of test diet	Likert scale questionnaire	3 night shifts, an average of 72 hours

Collaborators and Investigators

• Sponsor: King's College London

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: November 29, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Drum2019RG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No