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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2020

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.

Interventions

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

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Blood glucose variability (mean amplitude of glycaemic excursions)
    • Time Frame: 4 days
    • 24-hr blood glucose variability measured by continuous glucose monitor
  • Blood glucose variability (coefficient variation)
    • Time Frame: 4 days
    • 24-hr blood glucose variability measured by continuous glucose monitor
  • Blood glucose variability (time in range)
    • Time Frame: 4 days
    • 24-hr blood glucose variability measured by continuous glucose monitor
  • Heart rate variability
    • Time Frame: 4 days
    • 24-hr heart rate variability measured by heart rate monitor

Secondary Measures

  • Acceptability of test diet
    • Time Frame: 4 days
    • Likert scale questionnaire

Participating in This Clinical Trial

Inclusion Criteria

  • Current night shift worker (defined as a period of work between midnight and 6am working 6 to 10 night shifts per month).
  • Not already participating in a clinical trial.
  • Able to give informed written consent
  • Body mass index between 18.5 and 30 kg/m2.
  • Non-smokers
  • No diagnosed 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).
  • No history of excess alcohol intake or substance abuse.
  • Happy to follow dietary instructions before and during the study.
  • Ability to prepare basic meals from ingredients provided.
  • No food intolerance, allergies, hypersensitivity or follow any dietary restrictions (e.g. gluten intolerance, coeliac, lactose intolerance, vegan or vegetarian) that will prevent your ability to follow the test diets.
  • Weight stable (no weight change by more than 3 kg in the last 2 months).
  • Able to understand the information sheet and willing to comply with study protocol.
  • No travel arrangements outside UK within the period of data collection.

Exclusion Criteria

  • Women who are pregnant, intending to become pregnant, or breastfeeding
  • Participation in another clinical trial
  • Unable to comply with the study protocol.
  • Weight change >3kg in preceding 2 months and body mass index <18.5 or >30 kg/m2.
  • Current smokers, or reported giving up smoking within the last 6 months History of substance abuse, previous or current high alcohol intake (>28 units/week for males and >21 units/week for females).
  • Reported history of Cardiovascular disease, diabetes, cancer, kidney, liver or bowel disease, gastrointestinal disorder or use of drug likely to alter gastrointestinal function)
  • Blood pressure ≥160/100 mmHg
  • Travel arrangements outside UK within the period of data collection

Gender Eligibility: All

Minimum Age: 25 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • King’s College London
  • Provider of Information About this Clinical Study
    • Sponsor

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